BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TRIFECTA VALVE

    MDR report key: 19696116 · Received July 8, 2024

    Report

    Report Number
    2135147-2024-03273
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    January 1, 2017
    Report Date
    July 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    PMA / PMN Number
    P100029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF TRIFECTA VALVE PROCEDURE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING ARTERIAL HYPERTENSION, DYSLIPIDEMIA, OBESITY, DIABETES MELLITUS, ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR PACEMAKER, STROKE, ACUTE CORONARY SYNDROME, PERCUTANEOUS CORONARY INTERVENTION, AND CHRONIC ARTERY BYPASS GRAFT. SOME OF THE COMPLICATIONS REPORTED WERE AORTIC VALVE INSUFFICIENCY, HOSPITALIZATION, AND ADDITIONAL SURGERY (VALVE-IN-VALVE); 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.

    Description of Event or Problem · 0

    THE ARTICLE, "A MULTIMODAL APPROACH TO PREDICT PROSTHESIS-PATIENT MISMATCH IN PATIENTS UNDERGOING VALVE-IN-VALVE TRANS-CATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE SINGLE CENTER STUDY TO TEST A MULTIMODAL IMAGING APPROACH TO PREDICT PATIENT-PROSTHESIS MISMATCH (PPM) RISK DURING THE TRANSCATHETER-AORTIC-VALVE-IMPLANTATION (TAVI) PLANNING PHASE AND ASSESS ITS CLINICAL PREDICTIVITY IN VALVE-IN-VALVE (VIV)-TAVI PROCEDURES. DEVICES INCLUDED IN THE STUDY WERE TRIFECTA, MITROFLOW, HANCOCK II, EPIC, TORONTO SPV, MAGNA EASE, FREEDOM SOLO, CARPENTIER EDWARDS, PERIMOUNT, AND EVOLUT. THE ARTICLE CONCLUDED IN VIV-TAVI USING SELF-EXPANDABLE SUPRA-ANNULAR VALVES, A MULTIMODAL IMAGING APPROACH MIGHT IMPROVE CLINICAL OUTCOME PREDICTING SEVERE PPM OCCURRENCE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS FRANCESCO BURZOTTA, DEPARTMENT OF CARDIOVASCULAR AND PULMONARY SCIENCES, UNIVERSITÀ CATTOLICA DEL SACRO CUORE, ROME, ITALY, [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2017 TO JANUARY 2023. A TOTAL OF 40 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 8 PREVIOUSLY RECEIVED AN ABBOTT DEVICE. ALL PATIENTS RECEIVED AN EVOLUT VALVE FOR THE VIV PROCEDURE. THE AVERAGE AGE WAS 77.5 YEARS AND THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED ARTERIAL HYPERTENSION, DYSLIPIDEMIA, OBESITY, DIABETES MELLITUS, ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR PACEMAKER, STROKE, ACUTE CORONARY SYNDROME, PERCUTANEOUS CORONARY INTERVENTION, CHRONIC ARTERY BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902195 SJM TRIFECTA VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R