BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694282 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00706
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    March 22, 2010
    Report Date
    May 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVASCULARIZATION AND INADEQUATE OCCLUSION ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME ANEURYSMS OR VESSELS. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K012985 AND K031168.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR # 2939204-2010-00634 AND MDR# 2939204-2010-00635. THE PATIENT UNDERWENT THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE RECURRENT FUSIFORM BASILAR TIP ANEURYSM. APPROXIMATELY SIX MONTHS POST PROCEDURE A REOCCURRENCE OF THE BASILAR TIP ANEURYSM WAS FOUND DURING A ROUTINE FOLLOW-UP. A SINGLE NON-BOSTON SCIENTIFIC COIL WAS SUCCESSFULLY PLACED DURING RE-INTERVENTION PRIOR A PERFORATION OF THE LEFT DISTAL POSTERIOR TEMPORAL ARTERY BY A GUIDEWIRE USED IN THE PROCEDURE. THE PROCEDURE WAS ABORTED DUE THE VESSEL PERFORATION. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿ALIVE, WITH RIGHT SIDED WEAKNESS¿.

    Description of Event or Problem · 1

    THIS REPORT IS RELATED TO MDR # 2939204-2010-00634 AND MDR# 2939204-2010-00635. THE PATIENT UNDERWENT THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE RECURRENT FUSIFORM BASILAR TIP ANEURYSM. APPROXIMATELY SIX MONTHS POST PROCEDURE, A RECURRENCE OF THE BASILAR TIP ANEURYSM WAS FOUND DURING A ROUTINE FOLLOW-UP. A SINGLE NON-BOSTON SCIENTIFIC COIL WAS SUCCESSFULLY PLACED DURING RE-INTERVENTION PRIOR A PERFORATION OF THE LEFT DISTAL POSTERIOR TEMPORAL ARTERY BY A GUIDEWIRE USED IN THE PROCEDURE. THE PROCEDURE WAS ABORTED DUE TO THE VESSEL PERFORATION. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿ALIVE, WITH RIGHT SIDED WEAKNESS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK536

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention TWO (B) (4) MATRIX2 STANDARD 360 10MM X 30CM| (B) (4) MATRIX2 STANDARD 360 4MM X 8CM COIL| (B) (4) MATRIX2 SOFT 360 5MM X 10CM COIL| (B) (4) MATRIX2 STANDARD 360 8MM X 20CM COIL