BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1756589 · Received July 14, 2010

    Report

    Report Number
    2939204-2010-00821
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510#: K050700.

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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 FIFTEENMONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO OCCLUDE THE LEFT INTERNAL CAROTID ARTERY ANEURYSM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    APPROXIMATELY FIFTEEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT A SECOND PROCEDURE TO OCCLUDE THE LEFT INTERNAL CAROTID ARTERY ANEURYSM. 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 74 YR Required Intervention (B) (4) - MATRIX2 360 ULTRASOFT SR| THREE (B) (4) - MATRIX2 360 ULTRASOFT SR| TWO (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 ULTRASOFT SR| (B) (4) - MATRIX2 360 ULTRASOFT SR| (B) (4) - MATRIX2 ULTRASOFT SR| (B) (4) - MATRIX2 SOFT 360 SR| THREE (B) (4) - MATRIX2 STANDARD 360 SR| THREE (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 ULTRASOFT SR| (B) (4) - MATRIX2 ULTRASOFT SR| TWO (B) (4) - MATRIX2 STANDARD 360 SR| (B) (4) - MATRIX2 STANDARD 360 SR