BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694167 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00380
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    October 9, 2006
    Report Date
    October 9, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA # OR 510 #: K050700. ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE LABELING FOUND THAT THE DIRECTIONS FOR USE NOTES THAT MULTIPLE PROCEDURES MAY BE REQUIRED TO OCCLUDE AN ANEURYSM. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT MONTHS AFTER THE SUCCESSFUL COIL EMBOLIZATION OF THE RIGHT OPHTHALMIC ARTERY ANEURYSM, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT A REOCCURRENCE OF THE ANEURYSM. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 59 YR Required Intervention TWO (B) (4) - MATRIX2 FIRM 3D COILS| (B) (4) - MATRIX2 SOFT 2D SR COIL| TWO (B) (4) - MATRIX2 SOFT 360 SR COILS| (B) (4) - MATRIX2 FIRM 360 COIL