NAVITOR TRANSCATHETER AORTIC VALVE
Report
- Report Number
- 2135147-2025-07059
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 7, 2025
- Report Date
- January 21, 2026
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NPT
- PMA / PMN Number
- P190023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF NAVITOR DEVICE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE. COMPLICATIONS REPORTED INCLUDED DEATH, STROKE, RENAL FAILURE, ATRIAL FIBRILLATION, SURGICAL INTERVENTION (PACEMAKER IMPLANT), HOSPITALIZATION/PROLONGED HOSPITALIZATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. LITERATURE ATTACHMENT: OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. LITERATURE ATTACHMENT: OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.
THE ARTICLE, "OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SHORT- AND MID-TERM OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN HEMODIALYSIS PATIENTS TO THOSE IN NON-HEMODIALYSIS PATIENTS AND STRATIFY THE RISK OF ALL-CAUSE MORTALITY AFTER TAVI IN HEMODIALYSIS PATIENTS. THE DEVICES INCLUDED IN THIS STUDY WERE NAVITOR, NAVITOR VISION, SAPIEN3, SAPIEN3 ULTRA RESILIA, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, AND EVOLUT FX. THE ARTICLE CONCLUDED THAT MID-TERM ALL-CAUSE AND MORTALITY AND HEART FAILURE HOSPITALIZATION WERE MORE FREQUENTLY OBSERVED IN HEMODIALYSIS PATIENTS. HEMODIALYSIS ITSELF WAS NOT ASSOCIATED WITH ALL-CAUSE MORTALITY OR THE COMPOSITE OUTCOME. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RYOSUKE HIGUCHI, DEPARTMENT OF CARDIOLOGY, SAKAKIBARA HEART INSTITUTE, 3-16-1 ASAHICHO, FUCHU, TOKYO 183-0003, JAPAN, WITH CORRESPONDING EMAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT TAVI BETWEEN 01 JANUARY 2021 TO 31 DECEMBER 2024. A TOTAL OF 2,888 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 85 YEARS OLD. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE.
THE ARTICLE, "OUTCOMES OF HEMODIALYSIS PATIENTS UNDERGOING CONTEMPORARY TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE SHORT- AND MID-TERM OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN HEMODIALYSIS PATIENTS TO THOSE IN NON-HEMODIALYSIS PATIENTS AND STRATIFY THE RISK OF ALL-CAUSE MORTALITY AFTER TAVI IN HEMODIALYSIS PATIENTS. THE DEVICES INCLUDED IN THIS STUDY WERE NAVITOR, NAVITOR VISION, SAPIEN3, SAPIEN3 ULTRA RESILIA, EVOLUT R, EVOLUT PRO, EVOLUT PRO+, AND EVOLUT FX. THE ARTICLE CONCLUDED THAT MID-TERM ALL-CAUSE AND MORTALITY AND HEART FAILURE HOSPITALIZATION WERE MORE FREQUENTLY OBSERVED IN HEMODIALYSIS PATIENTS. HEMODIALYSIS ITSELF WAS NOT ASSOCIATED WITH ALL-CAUSE MORTALITY OR THE COMPOSITE OUTCOME. [THE PRIMARY AND CORRESPONDING AUTHOR WAS RYOSUKE HIGUCHI, DEPARTMENT OF CARDIOLOGY, SAKAKIBARA HEART INSTITUTE, 3-16-1 ASAHICHO, FUCHU, TOKYO 183-0003, JAPAN, WITH CORRESPONDING EMAIL: [email protected].] THIS STUDY INCLUDED PATIENTS WHO UNDERWENT TAVI BETWEEN 01 JANUARY 2021 TO 31 DECEMBER 2024. A TOTAL OF 2,888 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH AN UNKNOWN AMOUNT RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 85 YEARS OLD. THE MAJORITY GENDER WAS FEMALE. COMORBIDITIES INCLUDED HEART FAILURE, HYPERTENSION, DIABETES, CANCER, STROKE, CHRONIC OBSTRUCTIVE CORONARY DISEASE, ATRIAL FIBRILLATION, CAROTID ARTERY DISEASE, MITRAL REGURGITATION, TRICUSPID REGURGITATION, AND PRIOR MYOCARDIAL INFARCTION, PERCUTANEOUS CORONARY INTERVENTION, CORONARY ARTERY BYPASS GRAFT, AND CORONARY ARTERY DISEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2753752 | NAVITOR TRANSCATHETER AORTIC VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | ABBOTT MEDICAL | UNK NAVITOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| S| R |