BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 3841057 · Received May 30, 2014

    Report

    Report Number
    2025587-2014-00335
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P980043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT HAS BEEN RECEIVED AT MEDTRONIC'S QUALITY LABORATORY AND CONTINUES TO UNDERGO ANALYSIS. A SUPPLEMENTAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED THAT ALL LEAFLETS WERE IN THE CLOSED POSITION WITH GOOD DEPTH OF COAPTATION. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE AND INTACT. ALL COMMISSURES WERE INTACT. HYDRODYNAMIC PULSE DUPLICATION TESTING AT 70 BEATS PER MINUTE WITH HIGH SPEED VIDEO OBSERVATION SHOWED NORMAL, FULL OPENING AND CLOSING LEAFLET MOTION WITH NO EVIDENCE OF LEAKAGE. FLOW THROUGH THE VALVE WAS DOCUMENTED USING ECHOCARDIOGRAPHY, DIGITAL HIGH SPEED IMAGING AND FLOW METER ASSESSMENT. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATION AS THE VALVE PERFORMED AS EXPECTED DURING LABORATORY TESTING. (B)(4).

    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 THAT FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, ECHOCARDIOGRAM REVEALED THAT THE LEAFLETS WERE NOT OPENING PROPERLY. THE VALVE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318219 HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION T505U225

    Patients

    Seq Age Sex Outcome Treatment
    1