BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 4431117 · Received January 19, 2015

    Report

    Report Number
    2015691-2015-00130
    Event Type
    Malfunction
    Date Received
    January 19, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 22, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTED DEVICE WAS RETURNED TO EDWARDS FOR ANALYSIS. AS RECEIVED, BLOOD WAS VISIBLE ON THE VALVE. TWO (2) COMMISSURAL WIREFORMS WERE SEVERELY BENT SIDEWAYS TOWARDS THEIR RESPECTIVE LEAFLET. THE DISTORTION OF THE WIREFORM AT THE COMMISSURES LED TO INCORRECT COAPTATION BETWEEN THE LEAFLETS AND A GAP BETWEEN TWO (2) LEAFLETS AT A COMMISSURE. THE SEWING RING HAD BEEN CUT AND THE CLOTH WAS TORN NEAR A COMMISSURE. THE X-RAY DEMONSTRATED A DISTORTED CONDITION OF THE WIREFORM. METHOD: X-RAY. ADDITIONAL MANUFACTURER NARRATIVE: THE CLINICAL OBSERVATION OF INADEQUATE LEAFLET COAPTATION CAUSED BY STENT DEFORMATION COULD BE CONFIRMED THROUGH VISUAL OBSERVATION. HOWEVER, BASED ON THE EVALUATION DONE BY ENGINEERING, THE ROOT CAUSE OF THE STENT DEFORMATION COULD NOT BE DETERMINED CONCLUSIVELY; THOUGH, IT IS LIKELY DUE TO THE HANDLING OF THE DEVICE. THE RETURNED DEVICE CONTAINED DRIED BLOOD AND ALSO A CUT IN THE SEWING RING CLOTH SUGGESTING THE DEVICE HAD BEEN USED. IT IS UNLIKELY THERE WAS A FLAW IN THE WIREFORM THAT WOULD CAUSE THE OBSERVED DEFORMATION. THE WIREFORM IS 100% VISUALLY INSPECTED. ANY IRREGULARITIES OR ALIGNMENT ISSUES WOULD LIKELY BE OBSERVED DURING INSPECTION. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. (B)(4). THE EXPLANTED DEVICE IS ANTICIPATED FOR RETURN TO EDWARDS LIFESCIENCES AND AN EVALUATION OF THE PRODUCT IS CURRENTLY PENDING ITS ARRIVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AT IMPLANT DUE TO INADEQUATE COAPTATION OF THE LEAFLETS, CAUSED BY A DEFORMED STENT. DURING IMPLANTATION, THE HOLDER WAS REMOVED AND THE SURGEON, AS REPORTED, OBSERVED A "MALFORMATION OF THE STENT" (VALVE STRUTS), CAUSING LACK OF LEAFLET COAPTATION. THIS WAS EXCISED AND REPLACED WITH A 21MM PERICARDIAL BIOPROSTHESIS. THE PATIENT WAS HOSPITALIZED IN STABLE CONDITION POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43516 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR