BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 5543514 · Received April 3, 2016

    Report

    Report Number
    3004478276-2016-00024
    Event Type
    Injury
    Date Received
    April 3, 2016
    Date of Event
    March 3, 2016
    Report Date
    April 4, 2017
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESIGN HISTORY RECORD REVIEW COMPLETED 10/18/2016. THE COMPLETE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL S HEART VALVE, MODEL ICV1209, S/N (B)(4), WERE PULLED AND REVIEWED BY QUALITY CONTROL AT LIVANOVA (B)(4) CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A PERCEVAL S HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. DHR REVIEW: NITINOL COMPONENT ONLY A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE COMPONENT HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE COMPONENT SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. THE RETURNED VALVE PROSTHESIS APPEARS IN GENERAL GOOD CONDITIONS. VISUAL INSPECTION COMPLETED MAR 15, 2017. THE SHAPE OF THE VALVE IN THE RETURNED STATUS, APPEARS IRREGULAR REASONABLY DUE TO THE MANIPULATION DURING THE IMPLANT / EXPLANT STEPS. ACCORDING TO THE CURRENT REVISION OF THE PROCEDURE AT THE TIME OF MANUFACTURE AND RELEASE, NO NON CONFORMITIES WERE OBSERVED. CORRECTED DATA: CORRECTED DATA, FOLLOW-UP REPORT #1 DID NOT INCLUDE THAT THE DEVICE WAS RETURNED ON APRIL 20, 2016.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON (B)(6) 2016 THAT A PATIENT WITH HISTORY OF AS AND CAD. PRE OP TEE SHOWED FUNCTIONAL BICUSPID AORTIC VALVE, MEAN GRADIENT OF 41 AND PEAK OF 64 MMHG WITH A 50% EF. STJ 20, AORTIC ANNULUS 23.6 MM FOR A RATIO OF .86. CABG X 2 PERFORMED VIA OPEN STERNOTOMY IN STANDARD FASHION. AFTER PROPER THE PERCEVAL VALVE SIZE PVS23 PLACEMENT WAS OBTAINED AND THE VALVE COLLAPSED PROPERLY, THE INFLOW RING WAS DEPLOYED AND THE POSITION WAS CHECKED THEN THE OUTFLOW RING WAS DEPLOYED AND THE VALVE OUTFLOW RINGS ARE EXPOSED ABOVE THE AORTOTOMY. GUIDE SUTURES REMOVED. BALLOON PLACED AND INFLATED TO 4 ATMS FOR 30 SEC THEN WARM SALINE SQUIRTED ON STENT. THE ANNULUS IS NOT SEEN ABOVE OR BELOW THE INFLOW RING. THE AORTOTOMY WAS CLOSED VERY, VERY CAREFULLY BECAUSE OF THE EXPOSED RINGS. TEE REVEALS INFLOW RING ABOVE ANNULUS IN LAX AND IN SAX NO MERCEDES SIGN SEEN ONLY STENT. THE PEVEVAL VALVE SIZE PVS23 WAS REPLACED WITH TRIFECTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199326 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. PVS23

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention