BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMR ETLOGIX MITRAL ANNUPLASTY RING

    MDR report key: 1903856 · Received November 20, 2010

    Report

    Report Number
    2015691-2010-14394
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 20, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K083623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = ALFIERI STITCH. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE DEVICE IS UNAVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 13 MG/DL, 110 MG/DL, 86 MG/DL, LO (LESS THAN 10 MG/DL), 112 MG/DL 2) 83 MG/DL, 136 MG/DL, 13 MG/DL, 123 MG/DL, AND 115 MG/DL. SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 5 MONTHS. ON 10/22/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), ADDITIONAL INFORMATION WAS RECEIVED. THE REASON FOR EXPLANTING THE DEVICE WAS NOTED TO BE DUE TO AN ALFIERI STITCH. HOWEVER, THROUGH THE OPERATIVE REPORT, IT WAS ALSO LEARNED THAT THE PATIENT UNDERWENT AN ECHO WHICH REVEALED SEVERE MITRAL STENOSIS. PER THE HEALTH-CARE PROVIDER, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A DEVICE MALFUNCTION BUT WAS PROCEDURE RELATED. ACCORDING TO THE OPERATIVE REPORT THE PATIENT HAD THE MITRAL VALVE REPAIR FOR SEVERE MITRAL INCOMPETENCE SECONDARY TO MILD MYXOMATOUS DEGENERATION. "AT THAT TIME, FLAPS WERE REPAIRED AND AN ALFIERI STITCH WAS PLACED BETWEEN THE A2 AND P2 LEAFLETS, AFTER HAVING PLACED THE ANNULOPLASTY RING SIZE 30, AT WHICH TIME INSPECTION OF THE VALVE WITH INSUFFLATION SALINE REVEALED A MILD-TO-MODERATE CENTRAL LEAK. AFTER PLACING THE ALFIERI STITCH, THE LEAK WAS GONE AND ECHOCARDIOGRAPHY SUGGESTED NO TECHNICAL PROBLEMS; HOWEVER, POSTOPERATIVELY, REPEAT ECHO REVEALED SEVERE MITRAL STENOSIS. SINCE THAT TIME, THE PATIENT HAS HAD RELATIVE HYPOTENSION AND EXERTIONAL EXERCISE INTOLERANCE. IT WAS FELT THAT EITHER REPAIR OR REPLACEMENT OF THE VALVE WAS INDICATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMR ETLOGIX MITRAL ANNUPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100 R-07E0912

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention