BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8042206 · Received November 6, 2018

    Report

    Report Number
    2025587-2018-02965
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    August 7, 2018
    Report Date
    November 6, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: OCHIAI T OUTCOMES OF SELF-EXPANDING VS. BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES FOR THE TREATMENT OF DEGENERATED AORTIC SURGICAL BIOPROSTHESES - A PROPENSITY SCORE-MATCHED COMPARISON CIRC J. 2018 SEP 25;82(10):2655-2662. DOI: 10.1253/CIRCJ.CJ-18-0157. EPUB 2018 AUG 2. 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 VIA LITERATURE REGARDING OUTCOMES OF SELF-EXPANDING VS. BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES FOR THE TREATMENT OF DEGENERATED AORTIC SURGICAL BIOPROSTHESES. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2012 AND AUGUST 2017. THE STUDY POPULATION INCLUDED 135 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 77 YEARS), 13 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHESES AND 24 PATIENTS WERE IMPLANTED WITH EVOLUT R BIOPROSTHESES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 30-DAYS, 1-YEAR, 6-MONTHS AND 1-YEAR MORTALITY WERE REPORTED DUE TO UNSPECIFIED REASONS. TWO DEATHS WERE REPORTED IN THE SELF-EXPANDING TRANSCATHETER HEART VALVE GROUP DURING THE FOLLOW-UP. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, SECOND VALVE, STROKE, MAJOR VASCULAR COMPLICATION, MAJOR BLEEDING AND MILD AORTIC REGURGITATION (AR). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883024 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention