BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 12189038 · Received July 19, 2021

    Report

    Report Number
    2015691-2021-04179
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 19, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. PER THE ARTICLE, THE SURGICAL VALVE AND TRANSCATHETER VALVE WERE EXPLANTED APPROXIMATELY FOUR (4) MONTHS LATER. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION AND SURGICAL VALVE IS IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. SVD, A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. THE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED. JONES TL, SHARMA V, GLOTZBACH JP, WELT FGP, TANDAR A. IS TIMING EVERYTHING? BIOPROSTHETIC VALVE FRACTURE IN VALVE-IN-VALVE TAVR. J CARD SURG. 2020 NOV;35(11):3242-3243. DOI: 10.1111/JOCS.14979. EPUB 2020 AUG 25. PMID: 32840902.

    Description of Event or Problem · 1

    ARTICLE "IS TIMING EVERYTHING? BIOPROSTHETIC VALVE FRACTURE IN VALVE-IN-VALVE TAVR" 2020 WILEY PERIODICALS LLC J CARD. SURG. 2020;1-2. IT WAS LEARNED THROUGH REVIEW OF THIS ARTICLE A (B)(6) YEAR-OLD MALE PATIENT WITH A 23MM AORTIC VALVE IMPLANTED SEVEN (7) UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE SYMPTOMATIC AORTIC STENOSIS (MEAN GRADIENT = 54MMHG). A 26MM EVOLUT-R TRANSCATHETER VALVE WAS IMPLANTED FOLLOWED BY BFV WAS PERFORMED. THE PATIENT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED ON POST-OPERATIVE DAY TWO (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084580 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES ASKU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R