BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 3081233 · Received April 26, 2013

    Report

    Report Number
    2025587-2013-00066
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE WAS DISTORTED; OVAL SHAPED. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. THE VALVE APPEARED SLIGHTLY DESICCATED POSSIBLY DUE TO THE FOUR DAY DURATION IN FORMALIN. ALL LEAFLETS APPEARED SLIGHTLY STIFF BUT FLEXIBLE POSSIBLY DUE TO BLOOD CONTACT, THE DECONTAMINATION PROCESS AND EXPOSURE TO FORMALIN. THE RIGHT AND NON-CORONARY CUSPS WERE INTACT. A SMALL TEAR OBSERVED ALONG THE FREE MARGIN OF THE LEFT CUSP APPEARED TO HAVE OCCURRED DURING IMPLANT. ALL COMMISSURES WERE INTACT. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATION OF A TORN LEAFLET. THE TEAR OCCURRED DURING IMPLANT AND WAS RELATED TO IMPLANT TECHNIQUE. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS SUTURED INTO POSITION AND WHEN THE CENTER CRADLE WAS REMOVED, THE PHYSICIAN NOTED ONE OF THE LEAFLETS APPEARED TORN AT THE FREE EDGE. THE VALVE WAS EXPLANTED AND ANOTHER VALVE OF THE SAME MODEL WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181118 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA T505

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention