BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 2923122 · Received January 18, 2013

    Report

    Report Number
    2134151-2013-00003
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 10, 2012
    Report Date
    July 29, 2013
    Manufacturer
    MEDTRONIC ATS MEDICAL
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 VALVE HAS NOT BEEN RETURNED FOR ANALYSIS. FROM THE INFORMATION RECEIVED, THE CAUSE OF THE HYPOTENSION AND THE LEAFLETS NOT OPENING MAY HAVE BEEN DUE TO THROMBUS ON THE VALVE. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S VALVE OF A SMALLER SIZE DUE TO VALVE AVAILABILITY. THE CAUSE OF THE VENTRICULAR DEFIBRILLATION AND SUBSEQUENT DEATH AFTER THE IMPLANT OF THE REPLACEMENT VALVE IS UNKNOWN. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE VALVE BE RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT UPON REOPENING THE HEART, THROMBUS WAS OBSERVED ON THE VALVE AND IN THE LEFT ATRIUM. IT ALSO WAS REPORTED THAT THE VALVE WAS NOT TESTED AFTER IMPLANT PRIOR TO CLOSING THE HEART.

    Additional Manufacturer Narrative · 1

    WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION AND DEVICE RETURN HAVE BEEN REQUESTED. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, IT WAS NOTED THAT THERE WAS NO TISSUE OR THROMBUS ON THE SEWING RING. THERE WAS AN OBSERVATION OF AREAS OF SCANT GRANULAR MATERIAL (THAT COULD BE THROMBUS OR DRIED BLOOD THAT HAD NOT BEEN RINSED OFF THE VALVE AT IMPLANT) ON THE LEAFLETS AND ORIFICE, INCLUDING SOME MATERIAL NEAR THE HINGES. THE VALVE WAS VISUALLY INSPECTED WITH NO ANOMALIES NOTED THAT WOULD HAVE IMPACTED THIS EVENT. AFTER THE VALVE WAS CLEANED AND DRIED, THE LEAFLETS WERE FULLY MOBILE. INSPECTION AND FUNCTIONAL TESTING OF LEAFLET MOTION, CLEARANCE AND CONTACT AREA WAS PERFORMED; THE RESULTS MET PROCESS REQUIREMENTS AND SPECIFICATIONS. THE ORIFICE, LEFT AND RIGHT LEAFLETS, AND STIFFENING RING WERE DIMENSIONALLY MEASURED AND MET THEIR ENGINEERING SPECIFICATIONS. THERE WERE NO PERFORMANCE ISSUES NOTED WITH THIS VALVE. A ROOT CAUSE OF THE CLINICAL OBSERVATION OF THE LEAFLETS NOT OPENING COULD NOT BE DETERMINED. IN SIMILAR CASES, TISSUE SURROUNDING THE MITRAL VALVE HAS IMPINGED ON THE LEAFLETS, OR THE VALVE HAS BEEN TOO LARGE FOR THIS PATIENT. IT WAS REPORTED THAT THE MEDTRONIC 27MM VALVE WAS REPLACED WITH A 25MM VALVE OF A DIFFERENT MANUFACTURER, WHICH MAY INDICATE THAT VALVE SIZING MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THIS CLINICAL OBSERVATION. PER THE INSTRUCTIONS FOR USE (IFU) FOR THIS VALVE: ¿THE ORIFICE MAY BE ROTATED IN A CLOCKWISE OR COUNTERCLOCKWISE DIRECTION. AFTER ORIENTATION OF THE VALVE ORIFICE IN THE PATIENT¿S ANNULUS, LEAFLET MOBILITY MAY BE DETERMINED WITH THE BLUE LEAFLET ACTUATOR.¿ (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING CLOSURE OF THE STERNUM FOLLOWING THE IMPLANT OF THIS 27MM MECHANICAL MITRAL HEART VALVE, THE PATIENT'S BLOOD PRESSURE DROPPED. THE PATIENT WAS RETURNED TO BYPASS, AND THE STERNUM WAS RE-OPENED. IT WAS REPORTED THAT THE VALVE LEAFLETS WERE NOT OPENING. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S 25MM MECHANICAL HEART VALVE. FOLLOWING COMPLETION OF THE IMPLANT OF THE SECOND VALVE, THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF). EXTERNAL DEFIBRILLATION RESTORED THE PATIENT'S SINUS RHYTHM AND BYPASS WAS CONCLUDED. A MEAN BLOOD PRESSURE OF APPROXIMATELY 60 MMHG WAS OBSERVED. APPROXIMATELY FIFTEEN MINUTES LATER, THE PATIENT EXPERIENCED THREE ADDITIONAL EPISODES OF VF. EXTERNAL DEFIBRILLATION WAS ADMINISTERED EACH TIME, AND WAS SUCCESSFUL FOR THE FIRST TWO EPISODES. SINUS RHYTHM COULD NOT BE RESTORED AFTER THE THIRD EPISODE, AND THE PATIENT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27172 OPEN PIVOT MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ MEDTRONIC ATS MEDICAL 500DM27

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Life Threatening| R