BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 2081335 · Received April 27, 2011

    Report

    Report Number
    2025587-2011-00056
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT LIKELY RELATED TO IMPLANT TECHNIQUE. ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LAB, THE VALVE WAS DILATED IN THE CORONARY SINUS AREAS. THERE WERE TWO AREAS OF PSEUDOANEURYSMS. A SMALL HOLE WAS NOTED AT THE RIGHT CORONARY SINUS MEASURING APPROX 7.2 MM X 1 MM. A LARGE HOLE WAS NOTED AT THE LEFT CORONARY SINUS MEASURING APPROX 16MM X 3MM. THE EDGES WERE ROLLED AND SMOOTH SUGGESTING ADVENTITIAL HEMORRHAGE. THE SEWING RING WAS EVERTED. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE AND INTACT. ALL COMMISSURES WERE INTACT. THERE WAS NO EVIDENCE OF HOST TISSUE ON THE VALVE. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PER THE IFU, BIOPROSTHESIS IMPLANTATION - TAKE CARE NOT TO EVERT (ROLL OUTWARD) THE INFLOW END OF THE BIOPROSTHESIS WHEN SUTURING THE VALVE TO THE PT'S ANNULUS. EVERSION COULD DAMAGE THE VALVE TISSUE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 5 MONTHS, WAS EXPLANTED DUE TO PSEUDOANEURYSM AND DEHISCENCE OF THE VALVE ROOT. AT EXPLANT, TWO CUTS/ TEARS WERE OBSERVED UNDER THE LEFT AND RIGHT CORONARY OSTIA. THE FIRST LAYER OF SUTURES ON THE INFLOW SIDE, WERE EVERTING SUTURES. THERE WAS NO AORTIC REGURGITATION. OBSERVATION OF THE EXPLANTED VALVE SHOWED INTACT CUSPS. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC ROOT BIOPROSTHESIS LWR MEDTRONIC HEART VALVES, INC. 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention