BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2071261 · Received April 27, 2011

    Report

    Report Number
    2015691-2011-15351
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = PARTIAL DEHISCENCE. CORRECTED DATA: THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO PARTIAL DEHISCENCE. UNFORTUNATELY, NO OTHER DETAILS WERE PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. DESPITE MULTIPLE FOLLOW UP ATTEMPTS, THE HEALTHCARE PROVIDER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. WITHOUT ADDITIONAL INFORMATION AND DEVICE RETURN, NO FURTHER INVESTIGATION CAN BE CONDUCTED INTO THE ROOT CAUSE OF THIS EXPLANT. THERE IS NO INDICATION OF AN EDWARDS' DEVICE QUALITY DEFICIENCY THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE IN THIS CASE, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 9 MONTHS, AND A VALVE REPLACEMENT WAS PERFORMED. THE REASON FOR EXPLANTING THE DEVICE WAS NOT PROVIDED, DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-09H1777

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R