BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1865491 · Received October 12, 2010

    Report

    Report Number
    2939204-2010-01017
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    May 10, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K# - K050700, K031049 AND K042539. 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.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K# - K050700, K031049 AND K042539.

    Description of Event or Problem · 1

    ON 280 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT A REOCCURRENCE OF THE ANEURYSM. DURING THIS SECOND PROCEDURE A STENT WAS SUCCESSFULLY PLACED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    TWO HUNDRED AND EIGHTY DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO TREAT A REOCCURRENCE OF THE ANEURYSM. DURING THIS SECOND PROCEDURE A STENT WAS SUCCESSFULLY PLACED WITH NO CLINICAL CONSEQUENCE TO THE PATIENT.

    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 42 YR Required Intervention TWO MICROPLEX COILS (MICROVENTION)| (B)(4) - GDC-10 ULTRASOFT (BOSTON SCIENTIFIC)| (B)(4) - MATRIX2 3D (BOSTON SCIENTIFIC)| 2 (B)(4) - MATRIX2 FIRM 3D (BSC)| TWO (B)(4) - MATRIX2 3D(BOSTON SCIENTIFIC)| 2 (B)(4) - MATRIX2 360 SR (BSC)| MATRIX2 FIRM 3D (SIZE UNKNOWN, BOSTON SCIENTIFIC)| 2 (B)(4) - MATRIX2 FIRM 3D (BSC)| (B)(4) - GDC-10 360 SOFT (BSC)| (B)(4) - MATRIX2 FIRM 3D (BOSTON SCIENTIFIC)