BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 4252217 · Received November 14, 2014

    Report

    Report Number
    2015691-2014-02712
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, MODERATE TO HEAVY CALCIFICATION WAS OBSERVED IN THE CUSP AREAS OF ALL THREE (3) LEAFLETS AND WAS CONFIRMED VIA X-RAY. ALL THREE (3) LEAFLETS EXHIBITED PARTIAL TEARS AT THEIR RESPECTIVE COMMISSURE; THESE TEARS DID NOT TEAR THROUGH THE ENTIRE THICKNESS OF THE LEAFLETS AND CALCIFICATION WAS OBSERVED NEAR THIS REGION. THICKENED AND SWOLLEN TISSUE WAS OBSERVED ON ALL THREE (3) LEAFLETS AT ALL THREE (3) COMMISSURES. HEMATOMA AND THROMBI WERE OBSERVED ON TWO (2) LEAFLETS ON THE OUTFLOW ASPECT. INCIDENTAL FINDINGS: THE WIREFORM OF TWO (2) COMMISSURES WERE DISTORTED; THESE DAMAGES ARE LIKELY DUE TO IMPLANT OR EXPLANT. THE CLINICAL REPORT OF STENOSIS COULD BE CONFIRMED AS CALCIFICATION RESTRICTED MOBILITY IN THE LEAFLETS AND LED TO STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.) AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE EXPLANTED DEVICE IS ANTICIPATED FOR RETURN TO EDWARDS AND AN EVALUATION OF THE PRODUCT IS CURRENTLY PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    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, EDWARDS RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AFTER FOURTEEN (14) YEARS, NINE (9) MONTHS DUE TO PROSTHETIC VALVE AORTIC STENOSIS. THIS WAS REPLACED WITH A 21MM PERICARDIAL BIOPROSTHESIS. THE PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU) IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738516 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R