BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFER TO H10.

    MDR report key: 6366593 · Received February 28, 2017

    Report

    Report Number
    2015691-2017-00519
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 6, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED, MARKETED, OR SOLD IN THE U.S.; HOWEVER, IT IS SIMILAR TO MODEL NUMBER 2800 WHICH IS MARKETED IN THE U.S. CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS PMA# P860057/S001. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE CLINICAL OBSERVATION WAS UNABLE TO BE CONFIRMED. AT THIS TIME, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS THROUGH THE USE OF EDWARDS QUALITY SYSTEMS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: REPORT OF LEAFLETS NOT COAPTING LEADING TO CENTRAL REGURGITATION AND PARAVALVULAR LEAK COULD NOT BE CONFIRMED THROUGH VISUAL EXAMINATION. REPORT OF THAT ONE OF THE LEAFLETS LOOKED SHORTER WAS CONFIRMED. LEAFLET 3 WAS LOWER BY APPROXIMATELY 0.25MM AS COMPARED TO LEAFLET 2 NEAR COMMISSURE 3. SERRATED MARKINGS WERE OBSERVED ON LEAFLETS 1 AND 2 NEAR COMMISSURE 2. X-RAY DEMONSTRATED WIREFORM INTACT AND COMMISSURE 2 BENT. SUTURE HOLES WERE VISIBLE AROUND THE SEWING RING. THE WIREFORM WAS EXPOSED ON COMMISSURE 3. FURTHER ASSESSMENT AND FUNCTIONAL TESTING IS BEING PERFORMED ON THE SUBJECT DEVICE. WHEN THE ASSESSMENT IS COMPLETE A SUPPLEMENTAL WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THIS CASE THE VALVE WAS EXPLANTED AT IMPLANT; HOWEVER, THERE WAS NO SERIOUS INJURY RELATED TO THE VALVE EXCHANGE NOR ALLEGED MALFUNCTION THAT LED TO SERIOUS INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ON PRODUCT EVALUATION, REPORT OF THAT ONE OF THE LEAFLETS LOOKED SHORTER WAS NOT CONFIRMED. HOWEVER, LEAFLET 3 WAS LOWER BY APPROXIMATELY 0.25MM AS COMPARED TO LEAFLET 2 NEAR COMMISSURE 3.

    Additional Manufacturer Narrative · 1

    ADDITIONAL TESTING PERFORMED UNDER (B)(4) STANDARDIZED IN VITRO TESTING CONDITIONS, THE IMMEDIATE FUNCTIONALITY OF THE VALVE IS NORMAL. THE TRF WAS 2.3 %, WHICH IS MORE THAN SIX TIMES LOWER THAN THE 15 % MAXIMUM ALLOWED FOR A VALVE OF THIS SIZE PER (B)(4) 2015.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION THAT A SURGICAL VALVE HAD TO BE EXPLANTED AT IMPLANT DUE TO LEAFLETS NOT COAPTING LEADING TO CENTRAL REGURGITATION. IT WAS REPORTED THAT ONE OF THE LEAFLETS LOOKED SHORTER COMPARED TO THE OTHER LEAFLETS AND THAT THIS COULD BE THE CAUSE OF THE CENTRAL LEAKAGE. REGURGITATION WAS NOTICED BEFORE ADMINISTRATION OF PROTAMINE. THE PATIENT WAS COMPLETELY WEANED FROM BYPASS WHEN THE DECISION TO EXPLANT THE SUBJECT VALVE WAS DETERMINED. NEW CANNULAE WERE INSERTED TO EXPLANT THE VALVE AND PLACE A NEW VALVE. THE SECOND VALVE WAS THE SAME MODEL AND SIZE AND IMPLANTED SUCCESSFULLY. PATIENT WAS NOTED AS TO HAVE MINOR ACUTE STROKE AND CONFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148942 REFER TO H10. HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES REFER TO H10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other