BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 2001313 · Received February 24, 2011

    Report

    Report Number
    2015691-2011-14881
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    September 2, 2010
    Report Date
    January 25, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEHISCENCE OF ANNULOPLASTY RING. DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: UNFORTUNATELY, THE EDWARDS DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RECEIVED SUTURE THREADS ARE EVIDENT IN RING. MINIMAL HOST TISSUE OVERGROWTH ONTO THE SEWING FABRIC. CUTS IN THE SEWING FABRIC IS EVIDENT; THE CUTS ARE MOST LIKELY DUE TO MECHANICAL DAMAGE AT EXPLANT. NO OTHER INCONSISTENCIES DETECTED OR IN THE X-RAY, AS THE RING IS INTACT. THE RETURNED DEVICE WAS EXAMINED VISUALLY AND WITH A LIGHT MICROSCOPE AND DIGITAL MICROSCOPE. X-RAY AND RULER ALSO USED. X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: HOST TISSUE/PANNUS GROWTH IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. LITERATURE DEFINES PANNUS AS A TYPE OF SCARRING AND TISSUE INGROWTH. IT IS NOT CURRENTLY POSSIBLE TO PREDICT THE OCCURRENCE AND SEVERITY FOR ANY GIVEN PATIENT WITH A BIOPROSTHETIC HEART VALVE/ANNULOPLASTY RING. A CERTAIN DEGREE OF HOST TISSUE GROWTH IS EXPECTED. HOWEVER, ABNORMAL OR SEVERE PANNUS GROWTH CAN EVENTUALLY AFFECT THE FUNCTION OF THE VALVE. ACCORDING TO LITERATURE, PANNUS TYPICALLY OCCURS BETWEEN 12 MONTHS TO 5 YEARS. PANNUS OCCURRING PRIOR TO 12 MONTHS IS RARE AND SUGGESTS PATIENT FACTORS MAY HAVE PLAYED A SIGNIFICANT ROLE. SINCE THE MECHANISM OF HOST TISSUE GROWTH IN BIOPROSTHETIC HEART VALVES/ANNULOPLASTY RINGS IS STILL NOT FULLY UNDERSTOOD, THE ROOT CAUSE FOR THE HOST TISSUE GROWTH FOR THIS PARTICULAR VALVE CANNOT BE DETERMINED AT THIS TIME.

    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 DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS AND 5 MONTHS. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO SEVERE MITRAL REGURGITATION AND A DEHISCED MITRAL VALVE RING. ACCORDING TO THE OPERATIVE REPORT: "(PATIENT'S NAME) IS A PLEASANT (B)(6) YEAR-OLD GENTLEMEN, WHO UNDERWENT A MITRAL ANNULOPLASTY AND POSTERIOR LEAFLET REPAIR IN 2002. HE IS NOW EVALUATED FOR PROGRESSIVE FATIGUE. LOWER EXTREMITY EDEMA, DYSPNEA ON EXERTION OVER 2 MONTHS...WORKUP REVEALED SEVERE MITRAL REGURGITATION, SEVERE TRICUSPID REGURGITATION, DEHISCED MITRAL VALVE RING, PATENT CORONARY ARTERIES, AND CHRONIC ATRIAL FIBRILLATION...THE PFO WHICH HAS BEEN IDENTIFIED ON THE INTRAOPERATIVE TRANSESOPHAGEAL ECHO WAS OPENED. THE EXPOSURE OF THE MITRAL VALVE WAS QUITE GOOD. THE PRE-EXISTING RING HAD DEHISCED OVER THE A2, A3, AND P3 PORTIONS. THE SUTURES THAT WERE STILL IN PLACE HOLDING IT IN WERE CUT, AND THE RING WAS REMOVED. THE REDUNDANT TISSUES OF THE ANNULUS WAS DEBRIDED SLIGHTLY." THE PATIENT'S VALVE WAS REPLACED WITH AN EDWARDS BIOPROSTHETIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4400 1F0978

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention