BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8716448 · Received June 20, 2019

    Report

    Report Number
    2025587-2019-01993
    Event Type
    Death
    Date Received
    June 20, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 15, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017651
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT PER THE PHYSICIAN THE CAUSE OF DEATH WAS THE LEFT CORONARY (LCA) OCCLUSION. ANGIOGRAM CONFIRMED A LCA OCCLUSION WITH THE POSSIBLE CAUSE BEING THE LEAFLET OF THE MOSAIC VALVE. THE EVOLUT VALVE WAS NOTED TO BE PROPERLY POSITIONED AND STABLE. THE LCA WAS SUCCESSFULLY STENTED, HOWEVER, HEMODYNAMICS NEVER RECOVERED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 305C221, SERIAL #: (B)(4), UBD: 25-MAY-2015, UDI#: (B)(4). CONCOMITANT PRODUCT BRAND NAME: MOSAIC. CONCOMITANT PRODUCT CODE: LWR. CONCOMITANT PMA/(510)K #: P990064. (B)(4). PRODUCT ANALYSIS: THE VALVES REMAIN IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCTS, 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 EIGHT YEARS AND SEVEN MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, DIZZINESS AND SHORTNESS OF BREATH WERE REPORTED. ECHOCARDIOGRAM REVEALED MODERATE CENTRAL AORTIC REGURGITATION AND A VALVE GRADIENT OF 19 MM HG. A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT WAS SCHEDULED. THE PHYSICIAN INDICATED THAT THE RING OF THE BIOPROSTHETIC VALVE MIGHT NEED TO BE ¿FRACTURED¿ DUE TO THE PATIENT¿S PHYSICAL SIZE AND PATIENT-PROSTHESIS MISMATCH. PRE-OPERATIVE COMPUTED TOMOGRAPHY IMAGING SHOWED A LEFT CORONARY HEIGHT OF LESS THAN 10 MILLIMETER (MM). DUE TO THIS, A COMPLETE BASILICA PROCEDURE ON THE LEFT CORONARY LEAFLET WAS PERFORMED (BIOPROSTHETIC OR NATIVE AORTIC SCALLOP INTENTIONAL LACERATION TO PREVENT IATROGENIC CORONARY ARTERY OBSTRUCTION). IMMEDIATELY FOLLOWING THE BASILICA PROCEDURE, A 23 MM TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED IN AN IDEAL POSITION, AND THE AORTIC INSUFFICIENCY WAS NOTED AS RESOLVED. HOWEVER, THE GRADIENT WAS NOTED TO BE 26 MM HG AND A POST VALVE IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 22 MM NON-MEDTRONIC BALLOON IN AN ATTEMPT TO ¿FRACTURE¿ THE RING OF THE PREVIOUS BIOPROSTHETIC VALVE. IMMEDIATELY FOLLOWING THE POST VALVE IMPLANT BAV, A DROP IN BLOOD PRESSURE WAS OBSERVED. THE TRANSCATHETER VALVE WAS SNARED INTO THE ASCENDING AORTA. A VENTRICULAR ASSIST DEVICE WAS PLACED, FOLLOWED BY CARDIOPULMONARY RESUSCITATION (CPR) AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT DID NOT RECOVER AND EXPIRED. IT WAS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. PER THE PHYSICIAN, THERE WAS A POSSIBLE LEFT CORONARY OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510509 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23-US 00763000017651

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death