BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

    MDR report key: 2905080 · Received January 9, 2013

    Report

    Report Number
    2015691-2013-19061
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    K083470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED RING HAS NOT BEEN RETURNED TO EDWARDS FOR EVALUATION AS IT WAS DISCARDED AT THS HOSPITAL. RING DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE VALVE REPAIR IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. LATE DEHISCENCE CAN OCCUR AS A RESULT OF SUCCESSIVE DILATATION OF CARDIAC STRUCTURES THAT RESULT FROM PROGRESSION OF DISEASE. THE AVAILABLE INFORMATION SUGGESTS NOTHING TO INDICATE A DEVICE QUALITY DEFICIENCY THAT MAY HAVE CAUSED RO CONTRIBUTED TO THIS EVENT. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA SURGEON THAT AN EDWARDS MITRAL ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 31 MONTHS. REPORT INDICATES THAT THE REASON FOR EXPLANT WAS RING DEHISCENCE AND THAT THE PT. DEVELOPED SHORTNESS OF BREATH AND FATIGUE. THE VALVE WAS RE-REPAIRED USING AN EDWARDS ANNULOPLASTY RING. OPERATIVE REPORT INDICATES: "THIS IS A (B)(6) GENTLEMAN WHO HAS A KNOWN HISTORY OF MITRAL VALVE DISEASE. HE UNDERWENT A MITRAL VALVE REPAIR APPROXIMATELY 2 YEARS AGO. IT IS APPARENT THAT HE DID AN ANNULOPLASTY WITH RESUSPENSION OF THE POSTERIOR LEAFLET WITH ARTIFICIAL CHORDAE. IT IS NOT APPARENT THAT HE DID ANY RESECTION TO THE POSTERIOR LEAFLET. NONETHELESS, HE WAS RECENTLY EVALUATED FOR PROFOUND SHORTNESS OF BREATH THAT HAS BEEN CRESCENDOING OVER A 2 TO 3 WEEK PERIOD OF TIME. ON INITIAL EVALUATION, HE WAS THOUGHT TO BE IN CONGESTIVE HEART FAILURE AND TREATED AS SUCH, HE WAS FURTHER EVALUATED WITH ON ECHOCARDIOGRAM AND THIS REVEALED SEVERE MITRAL REGURGITATION WITH PARTIAL DEHISCENCE OF THE ANNULOPLASTY RING. INTRAOPERATIVE TRANSESOPHAGEAL ECHO DEMONSTRATED A SEVERELY BILLOWING POSTERIOR LEAFLET WITH PROLAPSE AND A SEVERELY DEHISCED RING WHICH APPROXIMATELY 2/3 OF THE RING WAS FLIPPING AROUND IN THE LEFT ATRIUM. THE ANTERIOR LEAFLET DID MOVE ADEQUATELY AND DID NOT APPEAR TO BE IMPAIRED. THE AORTIC VALVE WAS NORMAL . LEFT VENTRICULAR CONTRACTILITY WAS GOOD OVERALL. HE DID HAVE SOME LEFT VENTRICULAR DILATION WITH SOME MILD DYSFUNCTION NOTING GLOBAL CONTRACTILITY WAS GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12734 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 5200 R-10A0008

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R