BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 2212788 · Received August 16, 2011

    Report

    Report Number
    2015691-2011-16049
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: CONCLUSION: FROM THE INFORMATION PROVIDED BY THE SURGEON, IT APPEARS THE SUTURES DURING IMPLANT WERE TOO CLOSE TO THE EDGE OF THE PATIENT'S ANNULUS WHICH ALLOWED THEM TO PULL THROUGH THE TISSUE. THE SUTURES DID NOT PULL THROUGH THE SEWING RING OF THE VALVE; THEREFORE, IT IS CONCLUDED THAT THIS EVENT WAS NOT DUE TO A MALFUNCTION OF THE DEVICE BUT DUE TO PATIENT FACTORS. IT WAS PREVIOUSLY REPORTED THAT THE DHR WAS IN PROCESS. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WAS BEING RETURNED. HOWEVER, IT WAS CONFIRMED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. THE SURGEON'S REPORT WAS ALSO INCORRECTLY REPORTED. BIOPROSTHETIC VALVE WAS PARTIALLY DETACHED AT THE SUTURE KNOTTING AREA DUE TO THE TEAR IN THE PATIENT'S TISSUE, HOWEVER THE CAUSE WAS NOT DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED. THE DHR REVIEW IS CURRENTLY IN PROCESS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT HAS NOT BEEN RETURNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    REPORTEDLY, THE 21MM VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2.83 MONTHS DUE TO REGURGITATION FROM A CUT ON PATIENT'S ANNULUS. IT WAS REPORTED THAT A PERIMOUNT VALVE WAS IMPLANTED FOR AORTIC VALVE REPLACEMENT (AVR) ON (B)(6) 2011. ON (B)(6) 2011, THE VALVE WAS EXPLANTED FOR AVR. AT THE EXPLANT, REGURGITATION WAS OBSERVED FROM A CUT ON THE TISSUE OF THE PATIENT'S ANNULUS LED BY A SUTURE ON THE ANNULUS. PER INFORMATION RECEIVED BY THE DEALER, THERE WAS AN ANEURYSM-LIKE THING OBSERVED AT THE REGURGITATION AREA. IT WAS ALSO REPORTED THROUGH THE DEALER THAT IT SEEMED THE CUSTOMER WAS CONSIDERING THAT THIS EVENT WAS CAUSED DUE TO THE SUTURING BEING SHORT ON THE TISSUE. SURGEON'S COMMENTS: BIOPROSTHETIC VALVE WAS PARTIALLY DETACHED AT THE SUTURE KNOTTING AREA DUE TO THE TEAR IN THE PATIENT'S TISSUE, HOWEVER, THE CAUSE WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 10J200

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R