BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAPPHIRE TENSION SAFE COIL

    MDR report key: 541322 · Received August 31, 2004

    Report

    Report Number
    2029214-2004-00050
    Event Type
    Death
    Date Received
    August 31, 2004
    Date of Event
    August 2, 2004
    Report Date
    August 27, 2004
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD 5 TOTAL ANEURYSMS, ONE OR WHICH, A 16MM SUPERIOR HYPHOPHYSEAL, RUPTURED BRINGING PT INTO HOSP. PT WAS NEUROLOGICALLY INTACT. DR COILED THE 16MM AN WITH ECHELON 10 AND COMBINATION OF 15 SAPPHIRE COILS WITH ASSISTANCE OF HYPERGLIDE BALLOON WITHOUT INCIDENT. DR THEN ACCESSED 3.8MM P-COMM AN WITH SAME ECHELON 10 AND ALSO HYPERGLIDE 4X20MM TO PROVIDE NECK PROTECTION. DR DEPLOYED 4MM ATLAS COIL WITH COMPARTMENTALIZED IN THE ANTERIOR PORTION OF THE AN AND DETACHED CLEANLY. DR THEN ATTEMPTED TO DEPLOY E-3-4-T10-TS. COIL PERFORATED THE POSTERIOR WALL OF THE AN AND CAUSED AN INTER-PROCEDURAL RUPTURE. DR INFLATED THE BALLOON TO MINIMIZE FLOW AND DETACHED THE COIL. DR THEN ATTMPTED TO DEPLOY A 2X4 TS COIL BUT CATHETER BACKED OUT OF AN. DR ATTEMPTED TO RE-ACCESS ANEURYSM WITH CATHETER RIDING OVER THE COIL BUT THE CATHETER CONTINUED TO BACK OUT. DR THEN RE-INSERTED CATHETER INTO AN AN INJECTED 1:1 N-BCA WITH TANTALUM TO STOP RUPTURE. EXTRAVASATION WAS STOPPED AND P-COMM WAS OPEN HOWEVER, PHYSICIAN NOTICED SOME DELAYED FILLING ON FOLLOW-UP ANGIOGRAPHY AND SENT PT TO CT. PT STROKED AND LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPPHIRE TENSION SAFE COIL DETACHABLE EMBOLIC COIL HCG MICRO THERAPEUTICS, INC. E-3-4-T10-TS 632536

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death