BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 5002107 · Received August 13, 2015

    Report

    Report Number
    2025587-2015-00859
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    April 25, 2015
    Report Date
    November 4, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED IT WAS BUILT TO SPECIFICATION AND MET ALL INSPECTION AND ACCEPTANCE CRITERIA. NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: MANAGEMENT STRATEGIES FOR ACUTE CORONARY OCCLUSION ASSOCIATED WITH COREVALVE TRANSCATHETER AORTIC VALVE REPLACEMENT AUTHORS: SREEDIVYA CHAVA, EDWARD TERRIEN, JOSEPH SCHMOKER, MARC TISCHLER, HAROLD L. DAUERMAN CITATION: J THROMB THROMBOLYSIS (2015) 40:198¿202 (DOI 10.1007/S11239-015-1222-6) DATE OF PUBLISH USED FOR EVENT DATE.

    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 ACUTE CORONARY ARTERY OCCLUSION SUBSEQUENT TO MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE IMPLANTATION. A (B)(6) FEMALE PATIENT WITH SEVERE SYMPTOMATIC AORTIC STENOSIS UNDERWENT SUCCESSFUL IMPLANT OF A MEDTRONIC 29-MM TRANSCATHETER BIOPROSTHETIC VALVE (SERIAL NOT REPORTED). IMMEDIATE POST-IMPLANT MEASURES SHOWED MINIMAL PRESSURE GRADIENT ACROSS THE AORTIC VALVE AND MILD PERIVALVULAR REGURGITATION. APPROXIMATELY 20 MINUTES LATER THE PATIENT WAS NOTED WITH SEVERE BRADYCARDIA, HYPOTENSION, ST SEGMENT CHANGES, AND LEFT VENTRICULAR WALL HYPOKINESIS DUE TO OCCLUSION OF THE LEFT MAIN CORONARY ARTERY (LMCA) OSTIUM BY A DISPLACED NATIVE AORTIC VALVE LEAFLET. A INTRA-AORTIC BALLOON PUMP WAS INSERTED AND THE LMCA WAS STENTED, RESULTING IN STABILIZED HEMODYNAMICS WITH NORMAL SYSTOLIC FUNCTION AND MILD PERIVALVULAR REGURGITATION. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN A STABLE CONDITION AND DISCHARGED FIVE DAYS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION IDENTIFIED THE BIOPROSTHETIC VALVE AS MODEL MCS-P3-943 AND SERIAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533480 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention