BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5054461 · Received September 3, 2015

    Report

    Report Number
    2025587-2015-00931
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 21, 2011
    Report Date
    August 11, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION FOR DEGENERATED BIOPROSTHETIC HEART VALVES AUTHORS: HOLGER EGGEBRECHT, MD, ULRICH SCHÄFER, MD, HENDRIK TREEDE, MD, PETER BOEKSTEGERS, MD, JÖRG BABIN-EBELL, MD, MARKUS FERRARI, MD, HELGE MÖLLMANN, MD, HELMUT BAUMGARTNER, MD, THIERRY CARREL, MD, PHILIPP KAHLERT, MD, PHILIPP LANGE, MD, THOMAS WALTHER, MD, RAIMUND ERBEL, MD, RAJENDRA H. MEHTA, MD, MS, MATTHIAS THIELMANN, MD CITATION: JACC CARDIOVASCULAR INTERVENTIONS NOV 2011;4(11):1218-27. (DOI: 10.1016/J.JCIN.2011.07.015)

    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 REVIEW OF AN EVALUATION OF PATIENTS WITH DEGENERATED SURGICALLY IMPLANTED BIOPROSTHETIC HEART VALVES WHO UNDERWENT VALVE-IN-VALVE (VIV) TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE STUDY POPULATION INCLUDED 47 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 79.8 YEARS). ELEVEN MEDTRONIC SURGICAL BIOPROSTHETIC VALVES (FROM TWO VALVE FAMILIES, SERIAL NUMBERS NOT REPORTED) WERE NOTED WITH STENOSIS AND/OR REGURGITATION AND REQUIRED VIV IMPLANT INTERVENTION. TWELVE MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVES (SERIAL NUMBERS NOT REPORTED) WERE UTILIZED AS THE VIV IMPLANT. ACROSS ALL PATIENTS, EIGHT DEATHS OCCURRED WITHIN 30 DAYS OF THE VIV PROCEDURE, FIVE OF WHICH WERE DEEMED CARDIAC-RELATED (FOUR LOW CARDIAC OUTPUT AND ONE ARRHYTHMIA); NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCTS. ACROSS ALL PATIENTS, ADVERSE EVENTS INCLUDED: PRE-VIV STENOSIS AND/OR REGURGITATION (N=47), POST-VIV VASCULAR COMPLICATIONS (N=6), POST-VIV PERMANENT PACEMAKER IMPLANT (N=5), POST-VIV RENAL FAILURE REQUIRING DIALYSIS (N=4), AND PERI-VIV SEVERE REGURGITATION AFTER INITIAL TAVI DEPLOYMENT REQUIRING AN ADDITIONAL TAVI ("VALVE-IN-VALVE-IN-VALVE", N=2). OF ALL ADVERSE EVENTS, THESE WERE ASSOCIATED WITH MEDTRONIC PRODUCTS: PRE-VIV SURGICAL BIOPROSTHETIC VALVES WITH STENOSIS AND/OR REGURGITATION (N=11, FROM TWO VALVE FAMILIES), POST-VIV PERMANENT PACEMAKER IMPLANT (N=4), AND PERI-VIV SEVERE REGURGITATION AFTER TOO-LOW INITIAL TAVI DEPLOYMENT REQUIRING AN ADDITIONAL TAVI (N=1). THE STUDY CONCLUDED VIV TRANSCATHETER IMPLANTS CAN BE PERFORMED WITH HIGH TECHNICAL SUCCESS RATES AND EXCELLENT POST-PROCEDURAL VALVULAR FUNCTION FOR THESE ELDERLY HIGH-RISK PATIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585252 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention