BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1746153 · Received June 28, 2010

    Report

    Report Number
    2025587-2010-00060
    Event Type
    Death
    Date Received
    June 28, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED AS THE VALVE FUNCTIONED ACCORDING TO SPECIFICATION DURING TESTING. H3 ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, ALL LEAFLETS WERE IN THE CLOSED POSITION WITH A GAP BETWEEN ALL CUSPS AT THE POINT OF COAPTATION. ALL LEAFLETS WERE INTACT AND SLIGHTLY STIFF BUT FLEXIBLE. ALL COMMISSURES WERE INTACT. PULSE DUPLICATION HYDRODYNAMIC TESTING DATA SHOWED THE GRADIENT WAS SLIGHTLY HIGHER THAN THE HISTORICAL TESTING DATA. REGURGITATION WAS MUCH SMALLER THAN THE BASELINE TESTING DATA. HIGH SPEED VIDEO EVALUATION DURING PULSE DUPLICATION SHOWED THE LEFT CUSP DID NOT OPEN FULLY AT THE LOWER FLOW RATE. AT HIGHER FLOW RATES, THE LEFT CUSP OPENING WAS NORMAL. THERE WAS NO EVIDENCE OF LEAKAGE UPON LEAFLET CLOSURE AND NO EVIDENCE OF GAPPING BETWEEN FREE EDGES. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE CAUSE OF DEATH WAS NOT REPORTED. ANALYSIS OF THE VALVE REVEALED NO ABNORMALITIES OR MALFUNCTION. SHOULD FURTHER INFORMATION REGARDING THE CAUSE OF DEATH BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE WAS ABANDONED AFTER IMPLANT DUE TO AORTIC INSUFFICIENCY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED FOUR DAYS POST IMPLANT. THE CAUSE OF DEATH WAS NOT RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death