BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1692812 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00691
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K050700.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: 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 FIVE MONTHS AFTER THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE LEFT INTERNAL CAROTID ARTERY ANEURYSM, THE ANEURYSM HAD RECANALIZED. THE PATIENT UNDERWENT A SECOND PROCEDURE DURING WHICH SEVEN COILS WERE IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE MONTHS AFTER THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE LEFT INTERNAL CAROTID ARTERY ANEURYSM, THE ANEURYSM HAD RECANALIZED. THE PATIENT UNDERWENT A SECOND PROCEDURE DURING WHICH SEVEN COILS WERE IMPLANTED. THERE WAS NO REPORTED 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 67 YR Required Intervention THREE MATRIX2 COILS - MODELS UNKNOWN