BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING

    MDR report key: 4201323 · Received October 27, 2014

    Report

    Report Number
    2015691-2014-02516
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 3, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS AS IT WAS DISCARDED BY THE HOSPITAL. WITHOUT RETURN OF THE DEVICE, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. RE-OPERATIONS OF FAILED ANNULOPLASTY RINGS ARE PRIMARILY A RESULT OF A PROGRESSION OF DISEASE OR TECHNICAL FAILURES AND ARE NOT RELATED TO PRODUCT MALFUNCTIONS. UNLIKE PROSTHETIC HEART VALVES, ANNULOPLASTY RINGS ARE AN ADJUNCT TO THE VALVE REPAIR. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    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 THROUGH EDWARDS IMPLANT PATIENT REGISTRY THAT A 34MM BIOPROSTHETIC MITRAL RING, IMPLANTED APPROXIMATELY THREE (3) YEARS AND EIGHT (8) MONTHS, WAS EXPLANTED DUE TO SEVERE STENOSIS AND SEVERE INSUFFICIENCY/REGURGITATION. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM PERICARDIAL VALVE. THERE WERE NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684482 CARPENTIER-EDWARDS® PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R