BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 2073431 · Received May 1, 2011

    Report

    Report Number
    2015691-2011-15392
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AS RECEIVED THE RING EXHIBITS MODERATE HOST TISSUE OVERGROWTH. SUTURE THREADS ARE EVIDENT IN THE SEWING RING. MINOR CUTS IN THE SEWING FABRIC IS EVIDENT MOST LIKELY DUE TO MECHANICAL DAMAGE AT EXPLANT. NO OTHER INCONSISTENCIES DETECTED OR IN THE X-RAY, AS THE BAND IS INTACT. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE AND DIGITAL MICROSCOPE. X-RAY AND LIGHT/DIGITAL MICROSCOPE. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CONCLUSION: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. OPERATIVE REPORT INDICATES THE EXPLANTED NATIVE VALVE WAS FOUND TO HAVE DEHISCENCE. THE SURGEON INDICATED THAT THE REASON FOR EXPLANT IS NOT RELATED TO EDWARDS' RING MALFUNCTION. DEVICE EVALUATION RESULTS AND CONCLUSIONS WILL REPORTED ONCE COMPLETED.

    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 REPORTED THAT THE EDWARDS PHYSIO RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS. UPON FOLLOW-UP WITH THE HEALTHCARE PROVIDER, IT WAS LEARNED THAT THE PATIENT EXPERIENCED REGURGITATION. OPERATIVE REPORT INDICATES THE EXCISED [NATIVE] VALVE WAS FOUND TO HAVE DEHISCENCE, AND WAS REPLACED WITH AN EDWARDS' VALVE. THE SURGEON INDICATED THAT THE REASON FOR EXPLANTING THE RING IS PATIENT RELATED AND NOT DUE 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-09E1230

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention