BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC AP

    MDR report key: 3140031 · Received May 31, 2013

    Report

    Report Number
    2134151-2013-00015
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT HAS BEEN RETURNED AND CONTINUES TO UNDERGO ANALYSIS. CONCLUSION: UPON COMPLETION OF ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION REVEALED NO ANOMALIES ON THE CARBON SUBASSEMBLY. THE VALVE LEAFLETS WERE FULLY MOBILE. ALL DIMENSIONS OF THE CARBON COMPONENTS AND STIFFENING RING MET THE ENGINEERING SPECIFICATIONS. FUNCTIONAL TESTING OF THE VALVE REVEALED NO ANOMALIES. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE ROOT CAUSE OF THE VALVE LEAFLET MOTION BEING BLOCKED COULD NOT BE DETERMINED AS THE LEAFLETS WERE DIMENSIONALLY TO SPECIFICATION AND FULLY MOBILE UPON ANALYSIS. IT WAS REPORTED THAT IMPINGEMENT TISSUE HAD BEEN REMOVED, WHICH LIKELY COULD BE THE CAUSE OF THE LEAFLET NOT MOVING PROPERLY. THE OPEN PIVOT IFU CAUTIONS, ¿TESTING OF LEAFLET MOTION MUST ONLY BE DONE WITH THE ENCLOSED BLUE LEAFLET ACTUATOR. USE OF ANOTHER INSTRUMENT MAY DAMAGE THE VALVE. IF THE LEAFLETS DO NOT MOVE FREELY DUE TO CONTACT WITH TISSUE, THE VALVE ORIFICE MAY BE ROTATED TO A MORE OPTIMAL POSITION. ROTATE THE ORIFICE ONLY AFTER THE SUTURE KNOTS HAVE BEEN TIED, SECURING THE CUFF TO THE TISSUE ANNULUS.¿ (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MECHANICAL VALVE, THE VALVE LEAFLET MOTION WAS BLOCKED. THE VALVE WAS REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE WITH NO ADVERSE PATIENT EFFECTS REPORTED. IT IS UNKNOWN IF THE IMPINGEMENT WAS ANATOMICAL OR SUB-VALVULAR TISSUE, HOWEVER, IT WAS REPORTED THAT IMPINGEMENT TISSUE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241309 AORTIC AP HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 505DA20 573912

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention