BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL CONDUIT

    MDR report key: 12520723 · Received September 23, 2021

    Report

    Report Number
    2025587-2021-02878
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P790007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LE RUZ R, ET AL. EDWARDS SAPIEN XT TRANSCATHETER PULMONARY VALVE IMPLANTATION: 5-YEAR FOLLOW-UP IN A FRENCH REGISTRY. CATHETER CARDIOVASC INTERV. 2021 JUL 6. DOI: 10.1002/CCD.29862. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE MWH), HANCOCK (PMA# P790007, PRODUCT CODE LWR). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE PATIENT OUTCOMES AFTER TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) WITH THE EDWARDS SAPIEN XT VALVE. ALL DATA WAS COLLECTED FROM A THREE-CENTER REGISTRY BETWEEN 2011 AND 2016. OF THE 62 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE; MEDIAN AGE 27 YEARS; MEAN WEIGHT 66 KG), 6 WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC VALVED CONDUIT: CONTEGRA (3) OR HANCOCK (3). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, FOUR DEATHS OCCURRED DURING FOLLOW-UP AFTER TPVR. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL CONTEGRA AND HANCOCK PATIENTS, ADVERSE EVENTS INCLUDED: TPVR WITH THE EDWARDS SAPIEN XT VALVE. THE DURATION FROM CONDUIT IMPLANT TO TPVR WAS A MEDIAN OF 10 YEARS. REASONS FOR REPLACEMENT CONSISTED OF PULMONARY STENOSIS, PULMONARY REGURGITATION (MILD TO SEVERE), OR MIXED STENOSIS/REGURGITATION. ADDITIONAL ADVERSE EFFECTS OBSERVED PRIOR TO TPVR: HEART FAILURE AND ELEVATED RIGHT VENTRICLE-TO-PULMONARY ARTERY GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416508 MEDTRONIC SURGICAL CONDUIT HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-CONDUIT

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R