NAVITOR TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2135147-2026-00420
- Event Type
- Injury
- Date Received
- January 26, 2026
- Date of Event
- October 26, 2023
- Report Date
- January 28, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- PMA / PMN Number
- P190023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
229 ADVERSE EVENTS THAT COULD BE RELATED TO THE NAVITOR DEVICE WERE REPORTED INCLUDING AORTIC DISSECTION, ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, CARDIAC ARREST, CARDIAC PERFORATION, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, DEVICE EMBOLIZATION, DEVICE MIGRATION, DEVICE RELATED EVENT - OTHER, DEVICE THROMBOSIS, ENDOCARDITIS, MYOCARDIAL INFARCTION, PCI, PERCUTANEOUS CORONARY INTERVENTION, PERMANENT PACEMAKER, READMISSION (VALVE RELATED), REINTERVENTION - AORTIC VALVE, STROKE - HEMORRHAGIC, STROKE - ISCHEMIC, STROKE - UNDETERMINED, TRANSIENT ISCHEMIC ATTACK (TIA), VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, RISK ASSESSMENT WAS COMPLETED FOR THE REPORTED INCIDENTS. THE DEATH EVENTS AND RATES REPORTED IN THIS STUDY WERE FOUND TO BE ANTICIPATED IN THE STUDY POPULATION AND ARE IN ALIGNMENT WITH RATES OBSERVED IN OTHER CLINICAL STUDIES. NO NEW RISKS HAVE BEEN IDENTIFIED FOR THIS POPULATION. NO NEW HAZARDS OR HARMS WERE IDENTIFIED THAT WOULD IMPACT THE BENEFIT/RISK PROFILE. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN 01 OCTOBER 2025 - 31 DECEMBER 2025.
H2. A CORRECTION REPORT HAS BEEN SUBMITTED BECAUSE THE INITIAL REPORT WAS SUBMITTED INADVERTENTLY. 229 ADVERSE EVENTS THAT COULD BE RELATED TO THE NAVITOR DEVICE WERE REPORTED INCLUDING AORTIC DISSECTION, ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, CARDIAC ARREST, CARDIAC PERFORATION, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, DEVICE EMBOLIZATION, DEVICE MIGRATION, DEVICE RELATED EVENT - OTHER, DEVICE THROMBOSIS, ENDOCARDITIS, MYOCARDIAL INFARCTION, PCI, PERCUTANEOUS CORONARY INTERVENTION, PERMANENT PACEMAKER, READMISSION (VALVE RELATED), REINTERVENTION - AORTIC VALVE, STROKE - HEMORRHAGIC, STROKE - ISCHEMIC, STROKE - UNDETERMINED, TRANSIENT ISCHEMIC ATTACK (TIA), VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS LIMITED INFORMATION WAS PROVIDED INCLUDING THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, RISK ASSESSMENT WAS COMPLETED FOR THE REPORTED INCIDENTS. THE DEATH EVENTS AND RATES REPORTED IN THIS STUDY WERE FOUND TO BE ANTICIPATED IN THE STUDY POPULATION AND ARE IN ALIGNMENT WITH RATES OBSERVED IN OTHER CLINICAL STUDIES. NO NEW RISKS HAVE BEEN IDENTIFIED FOR THIS POPULATION. NO NEW HAZARDS OR HARMS WERE IDENTIFIED THAT WOULD IMPACT THE BENEFIT/RISK PROFILE. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, THERE WAS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING. THEREFORE, NO REMEDIAL ACTION IS REQUIRED AT THIS TIME. D4. PRIMARY UDI NUMBER: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. . D6A - IMPLANT DATE: THE EARLIEST IMPLANT DATE WAS USED. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN (B)(6) 2025 - (B)(6) 2025. ATTACHED: CSV FILE.
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY DATA THAT NAVITOR DEVICES MAY BE RELATED TO 229 ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY INCLUDING: AORTIC DISSECTION, ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, CARDIAC ARREST, CARDIAC PERFORATION, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, DEVICE EMBOLIZATION, DEVICE MIGRATION, DEVICE RELATED EVENT - OTHER, DEVICE THROMBOSIS, ENDOCARDITIS, MYOCARDIAL INFARCTION, PCI, PERCUTANEOUS CORONARY INTERVENTION, PERMANENT PACEMAKER, READMISSION (VALVE RELATED), REINTERVENTION - AORTIC VALVE, STROKE - HEMORRHAGIC, STROKE - ISCHEMIC, STROKE - UNDETERMINED, TRANSIENT ISCHEMIC ATTACK (TIA), VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE NAVITOR DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. STS/ACC TVT REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - RWD2300134. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN 26 OCTOBER 2023 ¿ 16 JANUARY 2025. PATIENTS¿ MEAN AGE IS 83 YEARS, RANGING FROM 54 TO 99 YEARS. 41% OF THE PATIENTS WERE MALE, 59% OF THE PATIENTS WERE FEMALE. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN 01 OCTOBER 2025 - 31 DECEMBER 2025. AS OF 07 NOVEMBER 2025, 3541 PATIENTS WERE TREATED WITH THE NAVITOR DEVICE AND 585 WITH THE PORTICO DEVICE IN THE STS/ACC TVT REGISTRY.
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Aortic Dissection was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Aortic Dissection was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Four out of 3541 (0.1%) subjects experienced Aortic Dissection since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,3160,4614,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Aortic Dissection was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Aortic Dissection was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Four out of 3541 (0.1%) subjects experienced Aortic Dissection since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,3160,4614,2993,4755,4114;4119,3221,4315,NA,0;41696508,1/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/16/2025 in a 72 year old Male. On 01/24/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,97.1,1/16/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;41916427,7/18/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/07/2023 in a 79 year old Male. On 07/18/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,79,Male,67.1,12/7/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;41999861,4/29/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/14/2024 in a 61 year old Female. On 04/29/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,61,Female,59.5,3/14/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42063760,7/7/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/15/2024 in a 80 year old Female. On 07/07/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,61.5,2/15/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42118186,7/10/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/16/2024 in a 84 year old Female. On 07/10/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,80.03,4/16/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42118186,1/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/16/2024 in a 84 year old Female. On 01/17/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,80.03,4/16/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42118302,7/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/04/2024 in a 80 year old Female. On 07/30/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,68,4/4/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42214168,11/26/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/24/2024 in a 85 year old Male. On 11/26/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Male,86.6,4/24/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42224627,10/17/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/09/2024 in a 75 year old Female. On 10/17/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Female,69.4,5/9/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42323156,5/14/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/13/2024 in a 90 year old Female. On 05/14/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,60.4,3/13/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42323156,8/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/13/2024 in a 90 year old Female. On 08/06/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,60.4,3/13/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42357186,5/1/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 89 year old Female. On 05/01/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,61.7,6/25/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42369435,7/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/03/2024 in a 76 year old Female. On 07/16/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,104.33,6/3/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42396766,1/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/27/2024 in a 80 year old Female. On 01/17/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,55.3,6/27/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42396902,6/19/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/19/2024 in a 74 year old Male. On 06/19/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Male,75,6/19/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42591776,2/21/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/29/2024 in a 69 year old Female. On 02/21/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,69,Female,86.1,8/29/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42683219,12/12/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/13/2024 in a 78 year old Male. On 12/12/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Male,126.7,6/13/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42683219,3/28/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/13/2024 in a 78 year old Male. On 03/28/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Male,126.7,6/13/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42696714,12/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/23/2024 in a 79 year old Male. On 12/30/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,79,Male,90.9,8/23/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43129508,2/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 70 year old Female. On 02/13/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Female,59.3,1/9/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43196492,1/22/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/16/2025 in a 80 year old Female. On 01/22/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,98.2,1/16/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43319710,12/27/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/17/2024 in a 83 year old Female. On 12/27/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,49.9,12/17/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43470929,11/25/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 74 year old Female. On 11/25/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Female,59,6/25/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43470929,4/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 74 year old Female. On 04/17/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Female,59,6/25/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43477231,10/4/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 09/30/2024 in a 76 year old Male. On 10/04/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,90.72,9/30/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43737473,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2025 in a 73 year old Female. On 01/09/2025, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,73,Female,95,1/8/2025,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;44095242,11/30/2023,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/16/2023 in a 94 year old Male. On 11/30/2023, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Male,54.9,11/16/2023,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;42299133,8/26/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 05/28/2024 in a 85 year old Male. On 08/26/2024, Atrial Fibrillation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Atrial Fibrillation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 139 out of 3541 (3.9%) subjects experienced Atrial Fibrillation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Male,101.5,5/28/2024,NI,1729,4614,2993,4755,4114;4119,3221,4315,NA,0;43101846,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 84 year old Female. On 01/07/2025, Bleeding - Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 51 out of 3541 (1.4%) subjects experienced Bleeding - Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,71.7,1/7/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43101846,1/8/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 84 year old Female. On 01/08/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 45 out of 3541 (1.3%) subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,71.7,1/7/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43105461,12/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/30/2024 in a 84 year old Female. On 12/30/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 45 out of 3541 (1.3%) subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,105.3,12/30/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43207614,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 78 year old Female. On 01/15/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 45 out of 3541 (1.3%) subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Female,80.35,1/14/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43504818,1/2/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2025 in a 86 year old Female. On 01/02/2025, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 45 out of 3541 (1.3%) subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,73.26,1/2/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43760620,12/5/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 12/05/2024 in a 84 year old Male. On 12/05/2024, Bleeding - Hematoma at Access Site was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Bleeding - Hematoma at Access Site was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 45 out of 3541 (1.3%) subjects experienced Bleeding - Hematoma at Access Site since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Male,67.9,12/5/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42357001,4/20/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/12/2024 in a 70 year old Male. On 04/20/2025, Bleeding - Life Threatening was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Life Threatening was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 16 out of 3541 (0.5%) subjects experienced Bleeding - Life Threatening since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Male,88.7,6/12/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;41933802,12/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/23/2024 in a 71 year old Male. On 12/05/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,71,Male,79.4,2/23/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;41999861,7/25/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/14/2024 in a 61 year old Female. On 07/25/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,61,Female,59.5,3/14/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;41999861,2/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/14/2024 in a 61 year old Female. On 02/17/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,61,Female,59.5,3/14/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42012823,12/19/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/20/2024 in a 90 year old Female. On 12/19/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,49,2/20/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42024005,5/10/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/25/2024 in a 81 year old Female. On 05/10/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Female,69,3/25/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42064077,11/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/12/2024 in a 78 year old Male. On 11/29/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Male,122.5,3/12/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42152390,3/29/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/10/2024 in a 89 year old Female. On 03/29/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,56.7,4/10/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42214168,12/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/24/2024 in a 85 year old Male. On 12/05/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Male,86.6,4/24/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42310529,4/5/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/01/2024 in a 86 year old Male. On 04/05/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,57.7,5/1/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42323585,7/28/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/20/2024 in a 89 year old Female. On 07/28/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,100.6,5/20/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42652063,5/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/03/2024 in a 81 year old Male. On 05/23/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Male,80.7,4/3/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42664360,1/18/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/29/2024 in a 86 year old Female. On 01/18/2025, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,85.2,8/29/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42697080,10/21/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/16/2024 in a 80 year old Female. On 10/21/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,51.4,8/16/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;42380585,10/27/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 06/20/2024 in a 82 year old Male. On 10/27/2024, Bleeding - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Bleeding - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 53 out of 3541 (1.3%) subjects experienced Bleeding - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Male,73.12,6/20/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43085331,1/6/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/06/2025 in a 79 year old Female. On 01/06/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 47 out of 3541 (1.3%) subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,79,Female,72.8,1/6/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 47 out of 3541 (1.3%) subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/15/2025, Bleeding - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Bleeding - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 47 out of 3541 (1.3%) subjects experienced Bleeding - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;37807721,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 82 year old Male. On 01/07/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Male,94.8,1/7/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43105532,12/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2024 in a 58 year old Female. On 12/05/2024, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,58,Female,78.5,12/5/2024,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43153501,1/16/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/16/2025 in a 86 year old Male. On 01/16/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,58.5,1/16/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/15/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43286567,1/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/13/2025 in a 83 year old Female. On 01/13/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,86.6,1/13/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43985342,5/9/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/09/2024 in a 86 year old Female. On 05/09/2024, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,46.4,5/9/2024,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;44131200,8/20/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/19/2024 in a 84 year old Female. On 08/20/2024, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,50.7,8/19/2024,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Cardiac Arrest was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Cardiac Arrest was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 87 out of 3541 (2.3%) subjects experienced Cardiac Arrest since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,1762,4614,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/15/2025, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 25 out of 3541 (0.7%) subjects experienced Cardiac Perforation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,2001,4614,2993,4755,4114;4119,3221,4315,NA,0;43737473,1/8/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2025 in a 73 year old Female. On 01/08/2025, Cardiac Perforation was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Perforation was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 25 out of 3541 (0.7%) subjects experienced Cardiac Perforation since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,73,Female,95,1/8/2025,NI,2001,4614,2993,4755,4114;4119,3221,4315,NA,0;42145206,9/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/29/2024 in a 89 year old Male. On 09/05/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Male,65.89,4/29/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42275724,4/2/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/27/2024 in a 76 year old Male. On 04/02/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,63,2/27/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42311338,3/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/08/2024 in a 64 year old Male. On 03/13/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,64,Male,67.1,5/8/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42323156,5/14/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/13/2024 in a 90 year old Female. On 05/14/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,60.4,3/13/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42323156,8/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/13/2024 in a 90 year old Female. On 08/06/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,60.4,3/13/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42335453,10/1/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/13/2024 in a 78 year old Female. On 10/01/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Female,52.2,5/13/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42357186,5/1/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 89 year old Female. On 05/01/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,61.7,6/25/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42369353,1/27/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/26/2024 in a 57 year old Female. On 01/27/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,57,Female,105,6/26/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42380611,8/28/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/07/2024 in a 70 year old Male. On 08/28/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Male,51.7,3/7/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42396902,6/23/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/19/2024 in a 74 year old Male. On 06/23/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Male,75,6/19/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42707795,8/26/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/26/2024 in a 80 year old Female. On 08/26/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,94.5,6/26/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43105532,12/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2024 in a 58 year old Female. On 12/05/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,58,Female,78.5,12/5/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43105532,12/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2024 in a 58 year old Female. On 12/16/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,58,Female,78.5,12/5/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43105532,12/27/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2024 in a 58 year old Female. On 12/27/2024, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,58,Female,78.5,12/5/2024,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/15/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43207614,1/16/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 78 year old Female. On 01/16/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Female,80.35,1/14/2025,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43737473,1/8/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2025 in a 73 year old Female. On 01/08/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,73,Female,95,1/8/2025,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Cardiac Surgery or Intervention - Other Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Cardiac Surgery or Intervention - Other Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 91 out of 3541 (2.2%) subjects experienced Cardiac Surgery or Intervention - Other Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42952253,12/3/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/03/2024 in a 77 year old Female. On 12/03/2024, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,77,Female,56,12/3/2024,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43105532,12/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2024 in a 58 year old Female. On 12/05/2024, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,58,Female,78.5,12/5/2024,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43135142,12/31/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/31/2024 in a 75 year old Male. On 12/31/2024, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Male,54.4,12/31/2024,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43153459,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 69 year old Male. On 01/09/2025, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,69,Male,94.8,1/9/2025,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Device Embolization was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Device Embolization was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Device Embolization since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43034592,1/2/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2025 in a 85 year old Male. On 01/02/2025, Device Migration was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Migration was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 12 out of 3541 (0.3%) subjects experienced Device Migration since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Male,67,1/2/2025,NI,2687,4614,1395,4755,4114;4119,3221,4315,NA,0;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Device Related Event - Other was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Related Event - Other was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Four out of 3541 (0.1%) subjects experienced Device Related Event - Other since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,4449,4614,2993,4755,4114;4119,3221,4315,NA,0;42356883,4/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/18/2024 in a 88 year old Female. On 04/09/2025, Device Thrombosis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Device Thrombosis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Five out of 3541 (0.1%) subjects experienced Device Thrombosis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Female,62.9,4/18/2024,NI,4440,4614,4001,4755,4114;4119,3221,4315,NA,0;42356883,4/8/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/18/2024 in a 88 year old Female. On 04/08/2025, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Endocarditis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Female,62.9,4/18/2024,NI,1834,4614,2993,4755,4114;4119,3221,4315,NA,0;42609248,7/26/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/22/2024 in a 88 year old Male. On 07/26/2025, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Endocarditis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,76.2,8/22/2024,NI,1834,4614,2993,4755,4114;4119,3221,4315,NA,0;43275606,1/2/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/19/2024 in a 54 year old Female. On 01/02/2025, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Endocarditis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,54,Female,56.88,12/19/2024,NI,1834,4614,2993,4755,4114;4119,3221,4315,NA,0;44131034,1/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2023 in a 91 year old Female. On 01/06/2024, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Endocarditis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,74.8,12/11/2023,NI,1834,4614,2993,4755,4114;4119,3221,4315,NA,0;44131284,4/11/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/21/2024 in a 81 year old Male. On 04/11/2024, Endocarditis was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Endocarditis was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 13 out of 3541 (0.4%) subjects experienced Endocarditis since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Male,88.5,2/21/2024,NI,1834,4614,2993,4755,4114;4119,3221,4315,NA,0;41774703,9/11/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2024 in a 77 year old Male. On 09/11/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,77,Male,63.1,1/2/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;41786794,3/8/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2024 in a 75 year old Female. On 03/08/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Female,66.6,1/8/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42209036,6/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 82 year old Female. On 06/29/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Female,113,4/2/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42224627,10/17/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/09/2024 in a 75 year old Female. On 10/17/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Female,69.4,5/9/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42310529,3/18/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/01/2024 in a 86 year old Male. On 03/18/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,57.7,5/1/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42357001,4/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/12/2024 in a 70 year old Male. On 04/07/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Male,88.7,6/12/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42380611,8/28/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/07/2024 in a 70 year old Male. On 08/28/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Male,51.7,3/7/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42385440,7/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/05/2024 in a 69 year old Male. On 07/29/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,69,Male,69.2,1/5/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42385455,11/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/23/2024 in a 89 year old Female. On 11/30/2024, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,54.7,2/23/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42484726,3/25/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/11/2024 in a 68 year old Female. On 03/25/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,68,Female,67,7/11/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42484726,8/4/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/11/2024 in a 68 year old Female. On 08/04/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,68,Female,67,7/11/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42651267,6/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/19/2024 in a 87 year old Male. On 06/24/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Male,148.3,6/19/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;42651443,4/21/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/05/2024 in a 72 year old Male. On 04/21/2025, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,72.1,6/5/2024,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;44095242,11/16/2023,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/16/2023 in a 94 year old Male. On 11/16/2023, Myocardial Infarction was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Myocardial Infarction was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 48 out of 3541 (1.4%) subjects experienced Myocardial Infarction since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Male,54.9,11/16/2023,NI,1969,4614,2993,4755,4114;4119,3221,4315,NA,0;41673795,2/7/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2023 in a 85 year old Male. On 02/07/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Male,82.6,12/5/2023,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;41774703,7/8/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2024 in a 77 year old Male. On 07/08/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,77,Male,63.1,1/2/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;41774703,9/11/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2024 in a 77 year old Male. On 09/11/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,77,Male,63.1,1/2/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;41803685,6/7/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/10/2024 in a 86 year old Female. On 06/07/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,59.2,1/10/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42186948,11/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/22/2024 in a 82 year old Male. On 11/05/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Male,137.7,4/22/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42357001,4/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/12/2024 in a 70 year old Male. On 04/09/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Male,88.7,6/12/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42456100,1/2/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/25/2024 in a 81 year old Male. On 01/02/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Male,59,7/25/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42484726,8/11/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/11/2024 in a 68 year old Female. On 08/11/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,68,Female,67,7/11/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42484726,8/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/11/2024 in a 68 year old Female. On 08/15/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,68,Female,67,7/11/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42651443,4/21/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/05/2024 in a 72 year old Male. On 04/21/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,72.1,6/5/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42696969,2/3/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/15/2024 in a 76 year old Male. On 02/03/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,77,5/15/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;43272776,2/11/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/03/2025 in a 88 year old Female. On 02/11/2025, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Female,89,1/3/2025,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;42524466,8/12/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 07/02/2024 in a 73 year old Male. On 08/12/2024, PCI was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of PCI was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 27 out of 3541 (0.8%) subjects experienced PCI since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,73,Male,75.4,7/2/2024,NI,4871,4624,2993,4755,4114;4119,3221,4315,NA,0;25048907,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 83 year old Female. On 01/15/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,77.2,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;40043997,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 85 year old Female. On 01/15/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,85,Female,81.2,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41673370,10/7/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/06/2023 in a 82 year old Male. On 10/07/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Male,97.1,12/6/2023,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41673623,11/20/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/05/2023 in a 88 year old Male. On 11/20/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,67.1,12/5/2023,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41696508,1/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/16/2025 in a 72 year old Male. On 01/17/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,97.1,1/16/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41852939,7/26/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 10/26/2023 in a 83 year old Female. On 07/26/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,64,10/26/2023,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41999842,11/12/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/13/2024 in a 84 year old Female. On 11/12/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,63.6,3/13/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42118291,12/17/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 88 year old Male. On 12/17/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,65.23,4/2/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42299585,10/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/23/2024 in a 80 year old Male. On 10/23/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Male,82.1,5/23/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42357211,5/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/14/2024 in a 76 year old Female. On 05/24/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,64.4,5/14/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42396790,12/2/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/24/2024 in a 87 year old Female. On 12/02/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Female,77.9,6/24/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42409234,4/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/15/2024 in a 91 year old Female. On 04/07/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,62,2/15/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42484726,8/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/11/2024 in a 68 year old Female. On 08/13/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,68,Female,67,7/11/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42519050,2/1/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/02/2024 in a 76 year old Male. On 02/01/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,73.8,7/2/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42534946,11/12/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/07/2024 in a 92 year old Male. On 11/12/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,92,Male,71.7,8/7/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42683219,3/28/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/13/2024 in a 78 year old Male. On 03/28/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Male,126.7,6/13/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42696969,2/3/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/15/2024 in a 76 year old Male. On 02/03/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,77,5/15/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42863558,9/16/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/26/2024 in a 86 year old Female. On 09/16/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,94.9,8/26/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42864514,12/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 10/18/2024 in a 83 year old Female. On 12/06/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,74.4,10/18/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43070417,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2025 in a 80 year old Female. On 01/09/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,67.1,1/2/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43101959,1/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 91 year old Female. On 01/13/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,64.7,1/7/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43120821,1/6/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2025 in a 78 year old Male. On 01/06/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Male,113.5,1/2/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43135435,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/06/2025 in a 87 year old Female. On 01/15/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Female,118,1/6/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43148069,1/21/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/16/2025 in a 72 year old Male. On 01/21/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,110.7,1/16/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43148213,1/13/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/10/2025 in a 76 year old Female. On 01/13/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,80.7,1/10/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/17/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43207614,1/16/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 78 year old Female. On 01/16/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Female,80.35,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43224068,12/24/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/23/2024 in a 90 year old Female. On 12/24/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,53.4,12/23/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43257865,1/10/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2025 in a 82 year old Male. On 01/10/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Male,68.4,1/8/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43319791,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/03/2025 in a 96 year old Female. On 01/07/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,96,Female,44,1/3/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43327691,1/8/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 67 year old Male. On 01/08/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,67,Male,86,1/7/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43382990,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 75 year old Female. On 01/15/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Female,80.5,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43436096,1/14/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 90 year old Female. On 01/14/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,70,1/14/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43470929,6/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 74 year old Female. On 06/29/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Female,59,6/25/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43637059,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/02/2025 in a 80 year old Male. On 01/09/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Male,77,1/2/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43760976,1/10/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 74 year old Female. On 01/10/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Female,78,1/9/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;44095242,11/20/2023,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/16/2023 in a 94 year old Male. On 11/20/2023, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Male,54.9,11/16/2023,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;44131231,1/12/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/11/2024 in a 95 year old Female. On 01/12/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,95,Female,46.5,1/11/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;44131308,8/9/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/05/2024 in a 92 year old Male. On 08/09/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,92,Male,60.6,8/5/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42299478,9/27/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 05/20/2024 in a 87 year old Male. On 09/27/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Male,54.89,5/20/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42369462,1/10/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 06/20/2024 in a 72 year old Male. On 01/10/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Male,78.83,6/20/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;42736307,8/27/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 08/27/2024 in a 88 year old Male. On 08/27/2024, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,78.5,8/27/2024,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;43352525,1/3/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/02/2025 in a 93 year old Male. On 01/03/2025, Permanent Pacemaker was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Permanent Pacemaker was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 568 out of 3541 (16.0%) subjects experienced Permanent Pacemaker since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,93,Male,96.16,1/2/2025,NI,1721,4624,2993,4755,4114;4119,3221,4315,NA,0;41830457,4/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 10/27/2023 in a 76 year old Female. On 04/30/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,64.3,10/27/2023,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;41830457,6/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 10/27/2023 in a 76 year old Female. On 06/23/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,64.3,10/27/2023,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42118291,12/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 88 year old Male. On 12/16/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,65.23,4/2/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42275724,4/2/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/27/2024 in a 76 year old Male. On 04/02/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Male,63,2/27/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42356883,4/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/18/2024 in a 88 year old Female. On 04/07/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Female,62.9,4/18/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42385495,10/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/18/2024 in a 81 year old Female. On 10/29/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Female,57.2,6/18/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42385495,5/14/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/18/2024 in a 81 year old Female. On 05/14/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Female,57.2,6/18/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42448310,12/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/18/2024 in a 93 year old Female. On 12/29/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,93,Female,49,4/18/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42609248,7/26/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/22/2024 in a 88 year old Male. On 07/26/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,76.2,8/22/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;43276034,6/2/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/29/2024 in a 80 year old Female. On 06/02/2025, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Female,57.61,8/29/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;44131034,12/18/2023,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2023 in a 91 year old Female. On 12/18/2023, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,74.8,12/11/2023,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;44131034,1/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2023 in a 91 year old Female. On 01/06/2024, Readmission (Valve Related) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Readmission (Valve Related) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 55 out of 3541 (1.6%) subjects experienced Readmission (Valve Related) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,74.8,12/11/2023,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;42118291,12/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 88 year old Male. On 12/16/2024, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 18 out of 3541 (0.5%) subjects experienced Reintervention - Aortic Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,65.23,4/2/2024,NI,4449,4607,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Reintervention - Aortic Valve was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Reintervention - Aortic Valve was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 18 out of 3541 (0.5%) subjects experienced Reintervention - Aortic Valve since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,4449,4624,2993,4755,4114;4119,3221,4315,NA,0;42052285,10/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/25/2024 in a 96 year old Female. On 10/30/2024, Stroke - Hemorrhagic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Hemorrhagic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 10 out of 3541 (0.3%) subjects experienced Stroke - Hemorrhagic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,96,Female,72.5,3/25/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42259221,8/1/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/27/2024 in a 82 year old Female. On 08/01/2024, Stroke - Hemorrhagic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Hemorrhagic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 10 out of 3541 (0.3%) subjects experienced Stroke - Hemorrhagic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Female,68.04,3/27/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;24003634,5/21/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/19/2024 in a 99 year old Female. On 05/21/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,99,Female,68.1,2/19/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42006744,11/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/14/2024 in a 91 year old Female. On 11/23/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,54,3/14/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42012771,11/25/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/26/2024 in a 81 year old Male. On 11/25/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Male,63,3/26/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42098875,6/10/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/08/2024 in a 71 year old Female. On 06/10/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,71,Female,62.5,4/8/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42118291,6/21/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 88 year old Male. On 06/21/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Male,65.23,4/2/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42118320,7/27/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/17/2024 in a 77 year old Male. On 07/27/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,77,Male,NI,4/17/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42190299,6/28/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/23/2024 in a 92 year old Female. On 06/28/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,92,Female,63.6,4/23/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42235125,11/24/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/08/2024 in a 75 year old Male. On 11/24/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Male,102.2,7/8/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42235125,12/10/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/08/2024 in a 75 year old Male. On 12/10/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Male,102.2,7/8/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42356883,4/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/18/2024 in a 88 year old Female. On 04/24/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,88,Female,62.9,4/18/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42369435,7/18/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/03/2024 in a 76 year old Female. On 07/18/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,104.33,6/3/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42385518,3/12/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/19/2024 in a 84 year old Male. On 03/12/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Male,82.5,4/19/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42609135,1/10/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/16/2024 in a 80 year old Male. On 01/10/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,80,Male,56.4,8/16/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42623831,8/11/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/06/2024 in a 86 year old Female. On 08/11/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Female,48.3,5/6/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42651267,6/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/19/2024 in a 87 year old Male. On 06/24/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Male,148.3,6/19/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42707722,11/12/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/10/2024 in a 72 year old Female. On 11/12/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,72,Female,75.6,6/10/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42736800,11/26/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/04/2024 in a 89 year old Male. On 11/26/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Male,56.7,4/4/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;43032827,12/21/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/04/2024 in a 76 year old Female. On 12/21/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,76,Female,80.3,12/4/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;43118242,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 95 year old Male. On 01/15/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,95,Male,65.7,1/15/2025,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;43129508,2/4/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 70 year old Female. On 02/04/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,70,Female,59.3,1/9/2025,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;43135142,1/11/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/31/2024 in a 75 year old Male. On 01/11/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,75,Male,54.4,12/31/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42118251,11/26/2024,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 04/15/2024 in a 74 year old Male. On 11/26/2024, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,74,Male,102.8,4/15/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;42335570,5/28/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 05/13/2024 in a 95 year old Male. On 05/28/2025, Stroke - Ischemic was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Stroke - Ischemic was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 121 out of 3541 (3.4%) subjects experienced Stroke - Ischemic since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,95,Male,55.3,5/13/2024,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;44131034,12/18/2023,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2023 in a 91 year old Female. On 12/18/2023, Stroke - Undetermined was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Stroke - Undetermined was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. Four out of 3541 (0.1%) subjects experienced Stroke - Undetermined since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,74.8,12/11/2023,NI,1770,4614,2993,4755,4114;4119,3221,4315,NA,0;41852939,7/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 10/26/2023 in a 83 year old Female. On 07/06/2024, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,64,10/26/2023,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;42082352,10/9/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/05/2024 in a 90 year old Female. On 10/09/2024, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,90,Female,54.1,4/5/2024,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;42298671,3/25/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/21/2024 in a 89 year old Female. On 03/25/2025, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,50.5,3/21/2024,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;42323019,2/5/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/23/2024 in a 87 year old Female. On 02/05/2025, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,87,Female,87,4/23/2024,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;42323618,7/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/30/2024 in a 89 year old Male. On 07/30/2024, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Male,77.1,4/30/2024,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;43349867,1/1/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/31/2024 in a 89 year old Female. On 01/01/2025, Transient Ischemic Attack (TIA) was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Transient Ischemic Attack (TIA) was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 24 out of 3541 (0.7%) subjects experienced Transient Ischemic Attack (TIA) since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,70.1,12/31/2024,NI,2109,4614,2993,4755,4114;4119,3221,4315,NA,0;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43105461,12/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/30/2024 in a 84 year old Female. On 12/30/2024, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,105.3,12/30/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/15/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43196414,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 82 year old Female. On 01/07/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,82,Female,66.3,1/7/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43207614,1/15/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/14/2025 in a 78 year old Female. On 01/15/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,78,Female,80.35,1/14/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43293803,12/20/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/19/2024 in a 89 year old Female. On 12/20/2024, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,89,Female,34,12/19/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Vascular Complication - Major was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Major was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 67 out of 3541 (1.9%) subjects experienced Vascular Complication - Major since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43101846,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 84 year old Female. On 01/07/2025, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 148 out of 3541 (4.2%) subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,71.7,1/7/2025,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43414560,12/20/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2024 in a 91 year old Female. On 12/20/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 148 out of 3541 (4.2%) subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,71,12/11/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;44131034,1/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/11/2023 in a 91 year old Female. On 01/06/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 148 out of 3541 (4.2%) subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,91,Female,74.8,12/11/2023,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;44131284,2/21/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/21/2024 in a 81 year old Male. On 02/21/2024, Vascular Complication - Minor was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Complication - Minor was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 148 out of 3541 (4.2%) subjects experienced Vascular Complication - Minor since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,81,Male,88.5,2/21/2024,NI,1888,4614,2993,4755,4114;4119,3221,4315,NA,0;43085331,1/6/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/06/2025 in a 79 year old Female. On 01/06/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,79,Female,72.8,1/6/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;43085829,1/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/09/2025 in a 83 year old Female. On 01/09/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;43101846,1/7/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/07/2025 in a 84 year old Female. On 01/07/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,71.7,1/7/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;43105461,12/30/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/30/2024 in a 84 year old Female. On 12/30/2024, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,84,Female,105.3,12/30/2024,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;43120789,11/7/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/07/2024 in a 86 year old Male. On 11/07/2024, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,83.8,11/7/2024,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Navitor Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,IN,"It was reported through Portico TVT Registry data that a Navitor Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, Vascular Surgery or Intervention - Unplanned was reported and is considered a Serious Injury. The relationship of the Serious Injury to the Navitor Titan could not be determined based on the limited data received from the registry.","An event of Vascular Surgery or Intervention - Unplanned was reported in the current reporting period. A more comprehensive assessment could not be performed as limited information was provided including that the device was not returned for analysis. Based on the limited information received, the cause of the reported incident could not be conclusively determined. A risk assessment was completed for the reported incident. 153 out of 3541 (4.3%) subjects experienced Vascular Surgery or Intervention - Unplanned since the beginning of the registry. The adverse events and rates reported in this study were found to be anticipated in the study population and are in alignment with rates observed in other clinical studies.;;No new risks have been identified for this population. No new hazards or harms were identified that would impact the benefit/risk profile. Based on a review of the available information, there was no indication of a product quality issue with regards to manufacture, design, or labeling. Therefore, no remedial action is required at this time. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,1888,4624,2993,4755,4114;4119,3221,4315,NA,0;
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY DATA THAT NAVITOR DEVICES MAY BE RELATED TO 229 ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURY INCLUDING: AORTIC DISSECTION, ATRIAL FIBRILLATION, BLEEDING - ACCESS SITE, BLEEDING - HEMATOMA AT ACCESS SITE, BLEEDING - LIFE THREATENING, BLEEDING - MAJOR, BLEEDING - OTHER, CARDIAC ARREST, CARDIAC PERFORATION, CARDIAC SURGERY OR INTERVENTION - OTHER UNPLANNED, DEVICE EMBOLIZATION, DEVICE MIGRATION, DEVICE RELATED EVENT - OTHER, DEVICE THROMBOSIS, ENDOCARDITIS, MYOCARDIAL INFARCTION, PCI, PERCUTANEOUS CORONARY INTERVENTION, PERMANENT PACEMAKER, READMISSION (VALVE RELATED), REINTERVENTION - AORTIC VALVE, STROKE - HEMORRHAGIC, STROKE - ISCHEMIC, STROKE - UNDETERMINED, TRANSIENT ISCHEMIC ATTACK (TIA), VASCULAR COMPLICATION - MAJOR, VASCULAR COMPLICATION - MINOR, VASCULAR SURGERY OR INTERVENTION - UNPLANNED THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE NAVITOR DEVICES COULD NOT BE DETERMINED BASED ON THE LIMITED DATA RECEIVED FROM THE REGISTRY. STS/ACC TVT REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - RWD2300134. THE DATA RECEIVED INDICATED THAT THE PROCEDURE DATE RANGE WAS BETWEEN (B)(6) 2023 ¿ (B)(6)2025. PATIENTS¿ MEAN AGE IS 81 YEARS, RANGING FROM 54 TO 99 YEARS. 41% OF THE PATIENTS WERE MALE, 59% OF THE PATIENTS WERE FEMALE. THIS REPORT IS FOR QUARTER 4 TIMEFRAME BETWEEN (B)(6) 2025 - (B)(6) 2025. AS OF (B)(6) 2025, 3541 PATIENTS WERE TREATED WITH THE NAVITOR DEVICE AND 585 WITH THE PORTICO DEVICE IN THE STS/ACC TVT REGISTRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237606 | NAVITOR TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | UNK NAVITOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Other| R| H |