BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1667148 · Received April 26, 2010

    Report

    Report Number
    2939204-2010-00669
    Event Type
    Injury
    Date Received
    April 26, 2010
    Date of Event
    October 1, 2009
    Report Date
    April 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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.

    Additional Manufacturer Narrative · 1

    PMA# OR 510#: K050700.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST PROCEDURE, ANGIOGRAPHY TAKEN TO ASSESS THE CAUSE AN UNRELATED SUBARACHNOID HEMORRHAGE (SAH) REVEALED A 75% REOCCURRENCE OF THE ANEURYSM. THE PATIENT UNDERWENT A SECOND COIL EMBOLIZATION PROCEDURE TO TREAT THE REOCCURRENCE DURING WHICH FOURTEEN COILS WERE SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST PROCEDURE, ANGIOGRAPHY TAKEN TO ASSESS THE CAUSE AN UNRELATED SUBARACHNOID HEMORRHAGE (SAH) REVEALED A 75% REOCCURRENCE OF THE ANEURYSM. THE PATIENT UNDERWENT A SECOND COIL EMBOLIZATION PROCEDURE TO TREAT THE REOCCURRENCE DURING WHICH FOURTEEN COILS WERE SUCCESSFULLY 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 55 YR Required Intervention (B) (4) - MATRIX2 360 SOFT SR COIL| (B) (4) - MATRIX2 360 SR COIL| (B) (4) - MATRIX2 360 SR COIL| (B) (4) - MATRIX2 SOFT SR COIL| (B) (4) - MATRIX2 360 SR COIL| (B) (4) - MATRIX2 360 SR COIL| TWO (B) (4) - MATRIX2 ULTRASOFT SR COILS| (B) (4) - MATRIX2 360 SR COIL