BEUDAMED
    FDA Adverse Event Death Summary report: N

    AORTIC VALVE GRAFT

    MDR report key: 7185453 · Received January 12, 2018

    Report

    Report Number
    3008592544-2018-00003
    Event Type
    Death
    Date Received
    January 12, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 16, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE VALVE PORTION OF THE VALVED GRAFT WAS REMOVED AND THE GRAFT WAS LEFT IN PLACE. THE PHYSICIAN SUBSEQUENTLY REPLACED AND SEWED A 23 MM MEDTRONIC MECHANICAL VALVE TO THE EXISTING GRAFT. THE PHYSICIAN REPORTED THAT THE THAT THE DEATH WAS DUE TO THE PATIENT'S OTHER COMORBIDITIES AND NOT RELATED TO THE VALVE OR ITS FUNCTION NOR WAS THERE ANY ALLEGATION THAT THE VALVE CONTRIBUTED TO THE PATIENT'S DEATH. ADDED PATIENT INITIALS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED ONE OF THE LEAFLETS WAS NOT RETURNED. THE VALVE WAS RECEIVED WITH ONE LEAFLET ATTACHED. THE SEWING RING WAS DAMAGED, AND THE GRAFT WAS NOT RETURNED. THE STIFFENING RING WAS COMPLETELY EXPOSED. THE EXISTING SEWING RING WAS SLIGHTLY DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE ATTACHED LEAFLET WAS RECEIVED IN CLOSED POSITION AND WAS INTACT WITH NO EVIDENCE OF DAMAGE SUCH AS CRACKS AND/OR SURFACE ANOMALIES. THE ATTACHED LEAFLET MOVED TO OPEN AND CLOSED POSITION WITHOUT DIFFICULTIES. BOTH INFLOW AND OUTFLOW VALVE HINGE MECHANISMS WERE INTACT. DAMAGE TO THE CARBON WAS NOTED. FINE CRACKS WERE OBSERVED ON THE RIM AT THE INFLOW ASPECT AND CRACKS AND MISSING CARBON PIECES WERE OBSERVED ON THE RIM AT THE OUTFLOW ASPECT. USING A LAB BLUE ACTUATOR TO TEST LEAFLET MOVEMENT, THE ONE LEAFLET MOVED WITHOUT DIFFICULTY. THE LOCK WIRE WAS PULLED OUT AND THE STIFFENING RING REMOVED FROM THE ORIFICE. A PIECE OF THE CARBON BROKE OFF (THE PIECE BETWEEN THE OBSERVED CRACKS). THE SERIAL NUMBER WAS VERIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND CONTINUES TO UNDERGO ANALYSIS. AT THE COMPLETION OF THE ANALYSIS A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF A NON-MEDTRONIC PROSTHETIC VALVE, DUE TO ENDOCARDITIS, MULTIPLE VEGETAT IONS AND AN ABSCESS, THE VALVE WAS EXPLANTED. PRIOR TO THE IMPLANT OF THIS 27 MM MECHANICAL VALVED GRAFT, VISUAL INSPECTION NOTED THE VALVE WAS INTACT. DURING THE IMPLANT, THE PHYSICIAN NOTED THAT ONE OF THE LEAFLETS HAD DETACHED AND WAS IN THE VENTRICULAR CAVITY. THE DEVICE WAS REMOVED AND REPLACED WITH A 23 MM VALVED GRAFT. LATER THAT DAY, THE PATIENT DIED OF SEVERE VENTRICULAR DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30841 AORTIC VALVE GRAFT HEART-VALVE, MECHANICAL LWQ MEDTRONIC, INC. 502AG27

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| R