BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 11142609 · Received January 8, 2021

    Report

    Report Number
    2025587-2021-00082
    Event Type
    Death
    Date Received
    January 8, 2021
    Date of Event
    December 16, 2020
    Report Date
    January 8, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000211158
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: EVPROPLUS-34US, SERIAL/LOT #: (B)(4), UBD: 30-JUN-2022, UDI#: (B)(4). PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM REVEALED A SEVERE LEAK. AT THAT TIME IT COULD NOT BE DETERMINED WHERE THE LEAK WAS COMING FROM BUT THE PHYSICIANS THOUGHT POSSIBLE PARAVALVULAR LEAK (PVL). A POST IMPLANT VALVE DILATION WITH 28 MILLIMETER NON-MEDTRONIC BALLOON WAS PERFORMED BUT THIS DID NOT ADDRESS THE LEAK. ACCORDING TO THE PHYSICIAN, THE PATIENT'S CALCIFIED AND TORTUOUS ANATOMY COULD HAVE CONTRIBUTED TO THE PVL. IT WAS ALSO REPORTED THAT THE PATIENT HAD A POSSIBLE S1 BICUSPID NATIVE VALVE AS THE RIGHT CORONARY CUSP (RCC) AND LEFT CORONARY CUSP (LCC) APPEARED FUSED. THE IMPLANTING TEAM DECIDED TO IMPLANT A SECOND TRANSCATHETER VALVE. DURING THE IMPLANT OF THE SECOND VALVE, THE FIRST VALVE DISLODGED. THE FIRST VALVE WAS MOVED UP OUT OF ANNULUS AND WAS SNARED ABOVE WHERE THE SECOND VALVE WAS TO BE DEPLOYED. THE SECOND VALVE WAS DEPLOYED. THE SEVERE PVL LEAK REMAINED AND WAS OBSERVED TO BE ISOLATED AROUND THE ANNULUS IN THE RCC AND LCC REGIONS. A 28 MILLIMETER NON-MEDTRONIC BALLOON POST DILATED THE SECOND VALVE WITH NO IMPROVEMENT. AT THIS POINT, SEVERAL CARDIOPULMONARY RESUSCITATION (CPR) CYCLES HAD BEEN PERFORMED. THE PATIENT WAS THEN PLACED ON CARDIOPULMONARY BYPASS FOLLOWED BY ADDITIONAL VENTRICULAR SUPPORT. HOWEVER, THE PATIENT DIED THE SAME DAY. THE PHYSICIANS SUSPECTED THE DEATH WAS CAUSED BY A POSSIBLE ASCENDING AORTIC DISSECTION CAUSED BY MOVING THE FIRST VALVE. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37709 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-34US 00763000211158

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R