BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDA BRECKER CURVE GUIDEWIRE

    MDR report key: 3874472 · Received June 16, 2014

    Report

    Report Number
    2025587-2014-00388
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    DQX
    PMA / PMN Number
    K132623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 GUIDEWIRE WAS DISCARDED BY THE ACCOUNT AND WILL NOT BE RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE GUIDEWIRE, WHICH WAS DISCARDED AT THE IMPLANT FACILITY. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED OR WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THIS GUIDEWIRE WAS INSERTED THROUGH A CATHETER INTO THE LEFT VENTRICLE AFTER CROSSING THE NATIVE VALVE. A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH NO ADVERSE EVENTS. THIS DEVICE¿S DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED, AND AS IT WAS BEING NAVIGATED WITHIN THE DESCENDING AORTA, THE GUIDEWIRE WAS FOUND OUTSIDE OF THE LEFT VENTRICLE IN THE ASCENDING AORTA. THE DCS WAS REMOVED AND THE VALVE WAS CROSSED AGAIN WITH THE SAME GUIDEWIRE. THE GUIDEWIRE WAS DEEMED TO BE IN A GOOD POSITION, SO THE DCS WAS RE-INSERTED AND THE IMPLANT WAS COMPLETED WITHOUT ISSUE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) CONFIRMED NO PARAVALVULAR LEAK AND NO CARDIAC TAMPONADE. THE DCS AND GUIDEWIRE WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT, AT WHICH POINT HYPOTENSION WAS NOTED. A TEE CONFIRMED CARDIAC TAMPONADE. AN EMERGENCY PERICARDIOCENTESIS WAS UNSUCCESSFUL. A FULL STERNOTOMY WAS PERFORMED, REVEALING A HOLE IN THE LATERAL WALL OF THE LEFT VENTRICLE. THE HOLE WAS REPAIRED, RESOLVING THE HYPOTENSION. NO OTHER ADVERSE EVENTS WERE REPORTED, AND THE PATIENT WAS REPORTED AS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352277 CONFIDA BRECKER CURVE GUIDEWIRE WIRE, GUIDE, CATHETER DQX HEART VALVES SANTA ANA GWBC30 91305579

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention