BEUDAMED
    FDA Adverse Event Death Summary report: N

    GOOSE NECK SNARE

    MDR report key: 1280944 · Received January 6, 2009

    Report

    Report Number
    2183870-2009-00001
    Event Type
    Death
    Date Received
    January 6, 2009
    Date of Event
    October 27, 2008
    Report Date
    December 9, 2008
    Manufacturer
    EV3 INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO CAPTURE FURTHER INFORMATION I.E. AUTOPSY, PROCEDURE REPORTS, X-RAY, CINE AND/OR IMAGES, THIS ALSO INCLUDED THE LOT NUMBER AND THE ACTUAL CAUSE OF DEATH. EV3 ALSO REQUESTED THE DEVICE FOR EVALUATION, HOWEVER, IT IS REPORTED THAT THE PHYSICIAN DOES NOT LIKE TO "GIVE IT OUT".

    Description of Event or Problem · 1

    THIS PROCEDURE OCCURRED IN ANOTHER COUNTRY, IN A IMPLANTATION OF A TRANSCUTANE AORTIC VALVE: THE GOOSENECK (GN) WAS USED FOR POSITIONING OF A TRANSCUTANE AORTIC VALVE. THE LOOP WAS POSITIONED AROUND A STRUT OF THE VALVE, THE SNARE CATHETER WAS ADVANCED AND THE LOOP WAS FIXED AROUND THE STRUT. AFTER POSITIONING THE VALVE, THE SNARE CATHETER WAS PULLED BACK, BUT THE LOOP WAS STILL CONTRACTED AND IT WAS NOT POSSIBLE TO REMOVE THE GN FROM STRUT AND VALVE. THE VALVE WITH THE GN WAS EXPLANTED. IT LOOKS LIKE THE DISTAL MARKER OF THE SNARE CATHETER DETACHED FROM THE CATHETER. SURGICAL INTERVENTION REQUIRED: THORACOTOMY. CURRENT PATIENT CONDITION OF IMPACT TO PATIENT: REPORTED AS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOOSE NECK SNARE DXE EV3 INC. GN2500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death