BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1694171 · Received May 19, 2010

    Report

    Report Number
    2939204-2010-00463
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    October 23, 2006
    Report Date
    October 23, 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 K #: K012985 AND K031168.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

    IT WAS REPORTED THAT APPROXIMATELY EIGHTEEN MONTHS POST INDEX PROCEDURE; THE PATIENT UNDERWENT A FURTHER PROCEDURE TO TREAT THE RECURRENCE OF THE ANEURYSM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION WITH CLOSURE OF THE ANEURYSM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention (B) (4) - MATRIX ULTRASOFT| EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC)| (B) (4) - MATRIX STANDARD 3D