BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 11340263 · Received February 17, 2021

    Report

    Report Number
    2025587-2021-00588
    Event Type
    Injury
    Date Received
    February 17, 2021
    Date of Event
    December 14, 2020
    Report Date
    February 17, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ENTA Y ET AL. PATIENTS' CHARACTERISTICS AND MORTALITY IN URGENT/EMERGENT/SALVAGE TRANSCATHETER AORTIC VALVE REPLACEMENT: INSIGHT FROM THE OCEAN-TAVI REGISTRY. OPEN HEART. 2020 DEC;7(2):E001467. DOI: 10.1136/OPENHRT-2020-001467. FIRST PUBLISHED: DECEMBER 14, 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 PREDICTORS FOR THE NEED FOR URGENT/EMERGENT/SALVAGE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WAS COLLECTED FROM A FOURTEEN-CENTER REGISTRY BETWEEN OCTOBER 2013 AND JULY 2016. THE STUDY POPULATION INCLUDED 1,613 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 84.4 YEARS AND A MEAN WEIGHT OF 48.7 KG. OF THOSE, 144 PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 80 DEATHS OCCURRED WITHIN THIRTY DAYS AFTER TAVR. MULTIPLE MANUFACTURERS TRANSCATHETER VALVES WERE IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: EMERGENT OR ELECTIVE EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, CONVERSION TO OPEN-HEART SURGERY, NEED FOR SECOND VALVE IMPLANTATION, NEW PERMANENT PACEMAKER IMPLANTATION, ACUTE CORONARY OBSTRUCTION, STROKE, CARDIAC TAMPONADE, VALVE EMBOLIZATION/DISLODGEMENT, MODERATE TO SEVERE AORTIC REGURGITATION, LIFE-THREATENING OR MAJOR BLEEDING, TRANSFUSION, MAJOR VASCULAR COMPLICATION, AND WORSENED CONGESTIVE HEART FAILURE AFTER TAVR. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236274 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1