BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1992748 · Received February 16, 2011

    Report

    Report Number
    2015691-2011-14804
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    September 6, 2010
    Report Date
    January 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. NO INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: RESPONSE WAS RECEIVED ON (B)(6) 2011. OPERATIVE REPORT WAS RECEIVED ON (B)(6) 2011. DEVICE IS NOT AVAILABLE FOR RETURN. EXPLANT WAS DUE TO PATIENT RELATED FACTORS AND NOT A MALFUNCTION OF THE ANNULOPLASTY RING.

    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, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A RESPONSE WAS RECEIVED FROM THE HEALTH CARE PROVIDER ALONG WITH THE OPERATIVE REPORT WHICH INDICATED THE ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH ANOTHER RING OF THE SAME MODEL, SAME SIZE, DUE TO AN UNSATISFACTORY MITRAL VALVE REPAIR AND NOT DUE TO A MALFUNCTION OF THE RING.PER THE OPERATIVE REPORT, "INITIALLY CHORDS WERE PLACED TO P2. THE POSTEROMEDIAL COMMISSURE WAS PLICATED. A 32 PHYSIO RING WAS IMPLANTED. THE LEFT ATRIUM WAS CLOSED AND THE PATIENT WAS BROUGHT OFF BYPASS. THIS SHOWED MILD TO MODERATE MITRAL REGURGITATION. AGAIN THE AORTA WAS CROSS CLAMPED AND CARDIOPLEGIA WAS GIVEN. THE CLEFT BETWEEN THE FIRST AND SECOND SCALLOP OF THE POSTERIOR LEAFLET WAS CLOSED. THIS DID NOT IMPROVE THE MITRAL REGURGITATION SO THE PATIENT WAS PLACED BACK ON CARDIOPULMONARY BYPASS AND THE AORTA WAS CROSS CLAMPED. CARDIOPLEGIA WAS GIVEN. THIS TIME THE RING WAS TAKEN OUT. THE GORTEX CHORDS WERE REMOVED. FURTHER GORTEX CHORDS WERE PLACE. A QUADRANGULAR RESECTION WAS THEN DONE ON THE MIDDLE SCALLOP. IT WAS REPAIRED WITH 5/0 PROLENE. THE GORTEX CHORDS WERE PLACED TO THE MIDDLE SCALLOP. THE 32 PHYSIO RING WAS RE-IMPLANTED. THE LEFT ATRIUM WAS CLOSED. THE HEART WAS THEN DEAIRED AND THE CROSS CLAMP REMOVED. THE HEART RETURNED TO SINUS RHYTHM. ATRIAL AND VENTRICULAR PACING WIRES WERE PLACE. WHEN THE PATIENT WAS WARM CARDIOPULMONARY BYPASS WAS WEANED WITHOUT ANY PROBLEMS. TRANSOESOPHAGEAL ECHO SHOWED TRACE TO MILD MITRAL REGURGITATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 10B052

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R