BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 12577411 · Received October 5, 2021

    Report

    Report Number
    2648612-2021-00096
    Event Type
    Injury
    Date Received
    October 5, 2021
    Report Date
    October 5, 2021
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, 173 PATIENTS HAD THEIR MECHANICAL VALVE REPLACED DUE TO AORTIC STENOSIS OR REGURGITATION. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE ARTICLE, "REDO-AORTIC VALVE REPLACEMENT IN PRIOR STENTLESS PROSTHETIC AORTIC VALVES: TRANSCATHETER VERSUS SURGICAL APPROACH", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO COMPARE OUTCOMES OF REDO-AORTIC VALVE REPLACEMENT (AVR) VIA SURGICAL OR TRANSCATHETER APPROACH IN PRIOR SURGICAL AVR WITH LARGE PERCENTAGE OF PRIOR STENTLESS SURGICAL AVR. FREESTYLE/COREVALVE/EVOLUT R/EVOLUT PRO (MEDTRONIC), SJM MECHANICAL (ABBOTT), SAPIEN/SAPIEN XT/SAPIEN S3 (EDWARDS LIFESCIENCES) AND OTHER VALVES WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT ALTHOUGH THE VALVE IN VALVE (VIV) TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) GROUP WERE HIGHER RISK PATIENTS, THERE WERE SIGNIFICANTLY FEWER PROCEDURAL COMPLICATIONS, SHORTER LENGTH OF STAY, AND SIMILAR MORTALITY OUTCOMES UP TO 1-YEAR FOLLOW-UP IN THE OVERALL PATIENTS AS WELL AS IN THE STENTLESS GROUP ANALYSIS. THE PRIMARY AUTHOR OF THE ARTICLE IS CHARLES H. CHOI MD, SECTION OF CARDIOVASCULAR MEDICINE, WAKE FOREST SCHOOL OF MEDICINE, WAKE FOREST BAPTIST HEALTH SYSTEM, WINSTON-SALEM, NORTH CAROLINA, USA. THE CORRESPONDENCE AUTHOR OF THE ARTICLE IS DAVID X. M. ZHAO, SECTION OF CARDIOVASCULAR MEDICINE, WAKE FOREST SCHOOL OF MEDICINE, WAKE FOREST BAPTIST HEALTH SYSTEM, 1 MEDICAL CENTER BOULEVARD, WINSTON-SALEM, NC 27157, USA WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477518 SJM MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention