PORTICO TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2135147-2026-00419
- Event Type
- Death
- Date Received
- January 26, 2026
- Date of Event
- February 29, 2024
- 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
42 EVENTS OF DEATH WERE REPORTED THAT COULD BE RELATED TO THE NAVITOR DEVICE, INCLUDING DEATHS OF ACUTE MYOCARDIAL INFARCTION, CARDIOVASCULAR PROCEDURE, HEART FAILURE, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, HEMORRHAGE, RENAL, STROKE, SUDDEN CARDIAC DEATH. 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 2 TIMEFRAME BETWEEN 01 OCTOBER 2025 - 31 DECEMBER 2025.
H2. A CORRECTION REPORT HAS BEEN SUBMITTED BECAUSE THE INITIAL REPORT WAS SUBMITTED INADVERTENTLY. 42 EVENTS OF DEATH WERE REPORTED THAT COULD BE RELATED TO THE NAVITOR DEVICE, INCLUDING DEATHS OF ACUTE MYOCARDIAL INFARCTION, CARDIOVASCULAR PROCEDURE, HEART FAILURE, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, HEMORRHAGE, RENAL, STROKE, SUDDEN CARDIAC DEATH. 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. B2: DATE OF DEATH: THE EARLIEST DATE OF DEATH WAS USED. 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 01 OCTOBER 2025 - 31 DECEMBER 2025.
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY DATA THAT NAVITOR DEVICES MAY BE RELATED TO 42 ADVERSE EVENTS WHICH ARE CONSIDERED DEATH INCLUDING: ACUTE MYOCARDIAL INFARCTION, CARDIOVASCULAR PROCEDURE, HEART FAILURE, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, HEMORRHAGE, RENAL, STROKE, SUDDEN CARDIAC DEATH 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 16 NOVEMBER 2023 ¿ 15 JANUARY 2025. PATIENTS¿ MEAN AGE IS 83 YEARS, RANGING FROM 54 TO 99 YEARS. 55% OF THE PATIENTS WERE MALE, 45% 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;42214168,12/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/24/2024 in a 85 year old Male. On 12/23/2024, patient death was reported due to Acute myocardial infarction. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Acute myocardial infarction was reported. 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. Six out of 3541 (0.2%) subjects experienced death due to Acute myocardial infarction since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,85,Male,86.6,4/24/2024,NI,1969,1802,2993,4755,4114;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,D,"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, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. 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. 14 out of 3541 (0.2%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,83,Female,66,1/9/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;43179157,1/21/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 94 year old Female. On 01/21/2025, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. 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. 14 out of 3541 (0.2%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,94,Female,44.4,1/15/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;43737473,2/3/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/08/2025 in a 73 year old Female. On 02/03/2025, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. 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. 14 out of 3541 (0.2%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,73,Female,95,1/8/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;8540670,9/4/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/12/2023 in a 94 year old Male. On 09/04/2024, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,94,Male,61.9,12/12/2023,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;41995893,11/18/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/11/2024 in a 86 year old Male. On 11/18/2024, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Male,81.2,3/11/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42033983,1/27/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/25/2024 in a 81 year old Female. On 01/27/2025, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,81,Female,78.7,3/25/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42248768,8/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/23/2024 in a 71 year old Male. On 08/16/2024, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,71,Male,87.1,1/23/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42369826,2/23/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/26/2024 in a 90 year old Male. On 02/23/2025, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,90,Male,73.5,6/26/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42432769,12/8/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/24/2024 in a 86 year old Male. On 12/08/2024, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Male,65.32,6/24/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42491097,7/12/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/31/2024 in a 79 year old Female. On 07/12/2025, patient death was reported due to Heart failure. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. 26 out of 3541 (0.7%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,79,Female,87.1,7/31/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42064275,3/4/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/02/2024 in a 84 year old Female. On 03/04/2025, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Female,84,4/2/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;42190370,10/3/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/14/2024 in a 81 year old Male. On 10/03/2024, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,81,Male,78.1,5/14/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;42299643,2/29/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/03/2024 in a 83 year old Female. On 02/29/2024, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,83,Female,61,1/3/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;42902543,2/10/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/12/2024 in a 80 year old Female. On 02/10/2025, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,80,Female,54.7,11/12/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;43232566,2/1/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 12/18/2024 in a 82 year old Male. On 02/01/2025, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,76.6,12/18/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;44131284,4/17/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/21/2024 in a 81 year old Male. On 04/17/2024, patient death was reported due to Infection. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,81,Male,88.5,2/21/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;42310529,4/9/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/01/2024 in a 86 year old Male. On 04/09/2025, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. 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 death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Male,57.7,5/1/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42335696,4/17/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/06/2024 in a 55 year old Male. On 04/17/2025, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. 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 death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,55,Male,61.5,6/6/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42490950,4/20/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/17/2024 in a 92 year old Female. On 04/20/2025, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. 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 death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,92,Female,59.9,7/17/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;42500560,11/26/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 07/17/2024 in a 75 year old Female. On 11/26/2024, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. 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 death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,75,Female,72.7,7/17/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;44131308,9/16/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/05/2024 in a 92 year old Male. On 09/16/2024, patient death was reported due to Other cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other cardiovascular reason was reported. 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 death due to Other cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,92,Male,60.6,8/5/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;43293680,12/6/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/19/2024 in a 75 year old Female. On 12/06/2024, patient death was reported due to Other non-cardiovascular reason. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Other non-cardiovascular reason was reported. 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. 130 out of 3541 (3.7%) subjects experienced death due to Other non-cardiovascular reason since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,75,Female,49.1,11/19/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;42098875,6/18/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/08/2024 in a 71 year old Female. On 06/18/2024, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,71,Female,62.5,4/8/2024,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;42323704,12/24/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/11/2024 in a 82 year old Male. On 12/24/2024, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,82,Male,100,6/11/2024,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;42403597,10/9/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 02/27/2024 in a 84 year old Male. On 10/09/2024, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Male,54.54,2/27/2024,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;42664360,1/28/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 08/29/2024 in a 86 year old Female. On 01/28/2025, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Female,85.2,8/29/2024,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;43118242,2/24/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 01/15/2025 in a 95 year old Male. On 02/24/2025, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,95,Male,65.7,1/15/2025,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;44095242,3/5/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 11/16/2023 in a 94 year old Male. On 03/05/2024, patient death was reported due to Pulmonary. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Pulmonary was reported. 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. 17 out of 3541 (0.5%) subjects experienced death due to Pulmonary since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,94,Male,54.9,11/16/2023,NI,4462,1802,2993,4755,4114;4119,3221,4315,NA,0;42012975,8/23/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 03/26/2024 in a 66 year old Female. On 08/23/2024, patient death was reported due to Renal. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Renal was reported. 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. Three out of 3541 (0.1%) subjects experienced death due to Renal since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,66,Female,122.5,3/26/2024,NI,2041,1802,2993,4755,4114;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,D,"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, patient death was reported due to Stroke. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Stroke was reported. 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. Eight out of 3541 (0.2%) subjects experienced death due to Stroke since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,87,Male,148.3,6/19/2024,NI,1770,1802,2993,4755,4114;4119,3221,4315,NA,0;39633428,2/28/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/23/2024 in a 91 year old Male. On 02/28/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,91,Male,76.7,5/23/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;42110782,12/13/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 04/10/2024 in a 75 year old Male. On 12/13/2024, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,75,Male,58.1,4/10/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;42293991,1/14/2025,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 05/23/2024 in a 92 year old Female. On 01/14/2025, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,92,Female,67,5/23/2024,NI,1762,1802,2993,4755,4114;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,D,"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, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,70,Male,51.7,3/7/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;42721311,10/8/2024,1/28/2026,11/7/2025,Navitor,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Navitor was implanted on 06/25/2024 in a 84 year old Female. On 10/08/2024, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Female,69,6/25/2024,NI,1762,1802,2993,4755,4114;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,D,"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, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Female,46.4,5/9/2024,NI,1762,1802,2993,4755,4114;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,D,"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, patient death was reported due to Sudden cardiac death. The relationship of the Death to the Navitor could not be determined based on the limited data received from the registry.","An event of death due to Sudden cardiac death was reported. 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 death due to Sudden cardiac death since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,84,Female,50.7,8/19/2024,NI,1762,1802,2993,4755,4114;4119,3221,4315,NA,0;42396899,12/6/2024,1/28/2026,11/7/2025,Portico,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK PORTICO,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Portico was implanted on 06/25/2024 in a 77 year old Female. On 12/06/2024, patient death was reported due to Heart failure. The relationship of the Death to the Portico could not be determined based on the limited data received from the registry.","An event of death due to Heart failure was reported. 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. Six out of 585 (1.0%) subjects experienced death due to Heart failure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,77,Female,69.2,6/25/2024,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;43485292,1/14/2025,1/28/2026,11/7/2025,Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Titan was implanted on 01/14/2025 in a 86 year old Male. On 01/14/2025, patient death was reported due to Cardiovascular procedure. The relationship of the Death to the Titan could not be determined based on the limited data received from the registry.","An event of death due to Cardiovascular procedure was reported. 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. 14 out of 3541 (0.2%) subjects experienced death due to Cardiovascular procedure since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,86,Male,108,1/14/2025,NI,4446,1802,2993,4755,4114;4119,3221,4315,NA,0;41944641,1/3/2025,1/28/2026,11/7/2025,Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Titan was implanted on 02/29/2024 in a 78 year old Male. On 01/03/2025, patient death was reported due to Infection. The relationship of the Death to the Titan could not be determined based on the limited data received from the registry.","An event of death due to Infection was reported. 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. 22 out of 3541 (0.6%) subjects experienced death due to Infection since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,78,Male,72.1,2/29/2024,NI,1930,1802,2993,4755,4114;4119,3221,4315,NA,0;42335570,5/30/2025,1/28/2026,11/7/2025,Titan,"Aortic Valve, Prosthesis, Percutaneously Delivered",NA,Unknown,UNK NAVITOR,NI,NI,P190023,NA,D,"It was reported through Portico TVT Registry data that a Titan was implanted on 05/13/2024 in a 95 year old Male. On 05/30/2025, patient death was reported due to Stroke. The relationship of the Death to the Titan could not be determined based on the limited data received from the registry.","An event of death due to Stroke was reported. 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. Eight out of 3541 (0.2%) subjects experienced death due to Stroke since the beginning of the registry. 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. Therefore, no remedial action is required at this time.",No Information,95,Male,55.3,5/13/2024,NI,1770,1802,2993,4755,4114;4119,3221,4315,NA,0;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,;
IT WAS REPORTED THROUGH STS/ACC TVT REGISTRY DATA THAT NAVITOR DEVICES MAY BE RELATED TO 42 ADVERSE EVENTS WHICH ARE CONSIDERED DEATH INCLUDING: ACUTE MYOCARDIAL INFARCTION, CARDIOVASCULAR PROCEDURE, HEART FAILURE, INFECTION, OTHER CARDIOVASCULAR REASON, OTHER NON-CARDIOVASCULAR REASON, PULMONARY, HEMORRHAGE, RENAL, STROKE, SUDDEN CARDIAC DEATH. 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 16 NOVEMBER 2023 ¿ 15 JANUARY 2025. PATIENTS¿ MEAN AGE IS 83 YEARS, RANGING FROM 54 TO 99 YEARS. 55% OF THE PATIENTS WERE MALE, 45% 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239817 | PORTICO TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | UNK PORTICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | Death |