BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS

    MDR report key: 2032018 · Received March 28, 2011

    Report

    Report Number
    2015691-2011-15105
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 26, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 ON THE SAME DAY OF SURGERY. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS ADMITTED WITH SEVERE AORTIC STENOSIS. CARDIAC CATHETERIZATION AND CARDIAC ECHOCARDIOGRAM CONFIRMED THE PRESENCE OF SEVERE AORTIC STENOSIS AND SEVERE CORONARY ARTERY DISEASE. HIS LEFT VENTRICULAR FUNCTION WAS NORMAL. HIS LEFT VENTRICLE WAS THICKENED AND HYPERTROPHIED. HIS ASCENDING AORTA WAS FREE OF CALCIFICATION. THE NATIVE AORTIC VALVE WAS TRICUSPID AND EXTENSIVELY CALCIFIED. THE ROOT OF THE AORTA WAS CALCIFIED ESPECIALLY ALONG THE AREA OF THE RIGHT CORONARY OSTIUM NECESSITATION CARE TO AVOID LIFTING THIS PLAQUE WITH THE SEQUELAE OF EXTENDING A PLANE OF DISSECTION ONTO THE RIGHT CORONARY ARTERY. INITIAL PLACEMENT OF A 23 MM EDWARDS VALVE RESULTED IN PERIVALVULAR LEAK CONFIRMED BY ECHO. THIS WAS ADJACENT TO THE AREA OF THE RIGHT CORONARY ARTERY WHERE THE AORTIC ROOT WAS CALCIFIED. THE VALVE WAS RE-EXAMINED AND THERE WAS AN AREA ALONG THE RIGHT CORONARY ANNULUS NEAR THE CONVERSION BETWEEN THE RIGHT AND THE NON-CORONARY ANNULUS THAT APPEARED TO HAVE BEEN TORN. A PLEDGET OF SUTURES WERE PASSED THROUGH THE ANNULUS AND THE SEWING RING IN ATTEMPT TO REPAIR THIS LEAK; HOWEVER, THIS LEAK REMAINED PERSISTENT. THEREFORE, THE VALVE WAS REMOVED AND REPLACED WITH ANOTHER EDWARDS VALVE OF THE SAME MODEL BUT SMALLER SIZE. EXAMINATION OF THE NEW VALVE CONFIRMED NO VALVULAR OR PERIVALVULAR AORTIC INSUFFICIENCY BY ECHO. PER THE HEALTH-CARE PROVIDER, THE REASON FOR EXPLANTING THE DEVICE WAS NOT RELATED TO A PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2700 R-09B0207

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention