BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2025587-2018-01946

    MDR report key: 7737437 · Received July 31, 2018

    Report

    Report Number
    2025587-2018-01946
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    March 30, 2014
    Report Date
    October 3, 2018
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ABDEL-WAHAB M ET AL. COMPARISON OF BALLOON-EXPANDABLE VS SELF-EXPANDABLE VALVES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: THE CHOICE RANDOMIZED CLINICAL TRIAL. JAMA. 2014 APR 16;311(15):1503-14. DOI: 10.1001/JAMA.2014.3316. EPUB 2014 MAR 30. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE 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.

    Additional Manufacturer Narrative · 1

    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 WHETHER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) HAS A BETTER RATE OF SUCCESS WITH A NON-MEDTRONIC BALLOON-EXPANDABLE DEVICE IN COMPARISON TO THE MEDTRONIC COREVALVE SELF-EXPANDABLE DEVICE. ALL DATA WERE COLLECTED FROM 5 CENTERS BETWEEN MARCH 2012 AND DECEMBER 2013. THE STUDY POPULATION INCLUDED 241 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80.75 YEARS), 120 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL COREVALVE PATIENTS, 11 DEATHS OCCURRED WITHIN 30 DAYS FOLLOWING TAVR PROCEDURE. OF THOSE DEATHS, 5 PERTAINED TO CARDIOVASCULAR CAUSES WHILE 6 WERE DUE TO ANY OTHER CAUSE. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL COREVALVE PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, VALVE-IN-VALVE IMPLANTATION, VALVE SNARING DUE TO DEEP IMPLANT, DEVICE MALPOSITIONING, DEVICE EMBOLIZATION (PROSTHESIS MOVED DURING OR AFTER DEPLOYMENT SUCH THAT IT LOST CONTACT WITH THE AORTIC ANNULUS), VALVE-RELATED DYSFUNCTION REQUIRING INTERVENTION, STROKE, MILD/MODERATE/SEVERE AORTIC REGURGITATION, MINOR/MAJOR/LIFE THREATENING BLEEDING, MINOR/MAJOR VASCULAR COMPLICATIONS, AND HIGH TRANSVALVULAR PRESSURE GRADIENTS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention