BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1933549 · Received December 20, 2010

    Report

    Report Number
    2015691-2010-14544
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 13, 2010
    Report Date
    November 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT AND/OR DEVICE STATUS IS REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET REGISTRY. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT A CONVENTIONAL CUSTOMER COMPLAINT. IN THIS CASE, IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 MONTHS. ON (B)(6) 2010, THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL REGURGITATION. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAD MITRAL VALVE REPAIR PERFORMED WITH REPAIR OF THE POSTERIOR LEAFLET AND A RING. HE HAD A DIFFICULT TIME POSTOPERATIVELY WITH A LOT OF NEUROLOGIC ISSUES WHICH FINALLY RESOLVED. HE, HOWEVER, HAD EVIDENCE OF RECURRENT MITRAL REGURGITATION THAT BECAME AT LEAST MODERATE IN SEVERITY, AND HE WAS IN A LOW OUTPUT STATE AND REALLY NEVER WAS ABLE TO IMPROVE FROM THAT. WITH DIURESIS WE ALSO DROVE UP HIS CREATININE AS HIGH AS 3, BUT IT WAS BACK DOWN TO 1.64 AT THIS TIME. HE, THEREFORE, HAD HIS MITRAL VALVE REPLACED. PER THE SURGEON, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-08M2669

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention