BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 18519577 · Received January 16, 2024

    Report

    Report Number
    2135147-2024-00255
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    January 1, 2013
    Report Date
    February 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRIFECTA VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR MYOCARDIAL INFARCTION, PERIPHERAL VASCULAR DISEASE, SYNCOPE, ATRIAL FIBRILLATION, PULMONARY HYPERTENSION, CHRONIC PULMONARY DISEASE, PRIOR STROKE, PRIOR TRANSIENT ISCHEMIC ATTACK, AND TUMOR. SOME OF THE COMPLICATIONS REPORTED WERE ACUTE KIDNEY INJURY, NEW ONSET ATRIAL FIBRILLATION, PERMANENT PACEMAKER IMPLANT, STROKE, TRANSIENT ISCHEMIC ATTACK, BLEEDING, AND PARAVALVULAR LEAK. 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. LITERATURE ATTACHMENT: ARTICLE TITLE " MINIMALLY INVASIVE SURGICAL AORTIC VALVE REPLACEMENT VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION IN LOW-RISK OCTOGENARIANS".

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT IS ESTIMATED. D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE ADDITIONAL PATIENT EFFECT OF MALFUNCTION REPORTED IN THE ARTICLE IS CAPTURED UNDER A SEPARATE MEDWATCH REPORT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE, "MINIMALLY INVASIVE SURGICAL AORTIC VALVE REPLACEMENT VERSUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION IN LOW-RISK OCTOGENARIANS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, SINGLE CENTER STUDY ON LOW-RISK (SOCIETY OF THORACIC SURGEONS [STS] SCORE<4%) OCTOGENARIANS BEFORE AND AFTER TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TF-TAVI) AND MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT (MINI-AVR) PERFORMED BETWEEN (B)(6) 2013 AND (B)(6) 2019; FOLLOW-UP WAS COMPLETED IN (B)(6) 2022. DEVICES INCLUDED IN THIS STUDY WERE SAPIEN 3/XT, EVOLUT R, PORTICO, TRIFECTA, ENABLE, PERCEVAL, INTUITY, AND OTHER UNKNOWN. THE ARTICLE CONCLUDED THAT IN THE PRESENT STUDY ON LOW-RISK OCTOGENARIANS, TRANSFEMORAL TAVI AND MINIMALLY INVASIVE AVR SHOWED COMPARABLE SHORT-TERM AND MID-TERM RESULTS. BOTH PROCEDURES ARE DEEMED SAFE AND EFFECTIVE. LARGER RANDOMIZED CONTROLLED TRIALS WILL BE REQUIRED TO DETERMINE WHICH LOW RISK PATIENTS WILL BENEFIT MOST FROM TAVI. [(B)(6)]. THE TIME FRAME OF THE STUDY WAS FROM (B)(6) 2013 TO (B)(6) 2019. A TOTAL OF 301 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 20 RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 83.8 YEARS AND THE AVERAGE GENDER WAS FEMALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR MYOCARDIAL INFARCTION, PERIPHERAL VASCULAR DISEASE, SYNCOPE, ATRIAL FIBRILLATION, PULMONARY HYPERTENSION, CHRONIC PULMONARY DISEASE, PRIOR STROKE, PRIOR TRANSIENT ISCHEMIC ATTACK, AND TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712635 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability| R| L