BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1691462 · Received May 17, 2010

    Report

    Report Number
    2939204-2010-00121
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    February 24, 2005
    Report Date
    February 24, 2006
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) COIL PROTRUSION. PMA# OR 510K#: K012985 AND K031168. ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATION NONCONFORMANCE OR MISUSE. HOWEVER, COIL PROTRUSION AND NEUROLOGICAL SYMPTOMS ARE KNOWN AND ANTICIPATED COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION PROCEDURES AND ARE LISTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, A TOTAL OF SEVEN COILS WERE DEPLOYED INTO THE LEFT ANTERIOR CEREBRAL ARTERY ANEURYSM. EMBOLISM AND COIL PROTRUSION WERE REPORTED AS TECHNICAL COMPLICATIONS ASSOCIATED WITH THE PROCEDURE. IMMEDIATELY AFTER TREATMENT THE SUBJECT WAS IMPROVED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SUCCESSFUL REINTERVENTION EIGHT MONTHS (DATE UNKNOWN) POST INDEX PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - FREMONT UNK535

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R (B) (4) - MATRIX STANDARD 3D| (B) (4) - MATRIX ULTRASOFT| (B) (4) - MATRIX ULTRASOFT| (B) (4) - MATRIX ULTRASOFT| (B) (4) - MATRIX FIRM 3D| EXCELSIOR 1018 MICROCATHETER (BOSTON SCIENTIFIC)| (B) (4) - MATRIX STANDARD-SR 2D| (B) (4) - MATRIX ULTRASOFT