BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 SOFT 360 SR COIL

    MDR report key: 1201778 · Received October 15, 2008

    Report

    Report Number
    2939204-2008-00471
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    August 14, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. BOSTON SCIENTIFIC HAS MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT WITHOUT RESULT. CURRENTLY THERE ARE NO FURTHER DETAILS TO REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED IN THE PATIENT, SO WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED, IT CAN BE CONCLUDED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE LABELING AND THAT THIS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. A REVIEW OF THE LABELING FOUND THAT IT CONTAINS LANGUAGE REGARDING THE THROMBUS AS A POTENTIAL COMPLICATION. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION OR NONCONFORMANCE FROM THE INFORMATION PROVIDED ON THE INVESTIGATION. THE LABELING NOTES THROMBUS IS A POTENTIAL COMPLICATION OF SUCH PROCEDURES, SO IT WAS DETERMINED THAT THIS WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    DURING THE EMBOLIZATION OF AN ANEURYSM, THE PATIENT SUFFERED AN EMBOLUS IN THE LEFT MIDDLE CEREBRAL ARTERY. IT WAS REPORTED THAT THE EMBOLUS WAS DUE TO ALTERED FLOW DURING THE PROCEDURE THAT THE PHYSICIAN RELATES TO "USER DEPENDENT INDIVIDUAL TECHNIQUE". THE EMBOLUS WAS PARTIALLY RESOLVED WITH ASPIRIN AND HEPARIN. THERE WAS NO REPORTED NEUROLOGICAL DEFICIT TO THE PATIENT WAS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 SOFT 360 SR COIL (HCG) DETACHABLE COIL HCG BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 490615-SR 11676146

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention THREE BOSTON SCIENTIFIC MATRIX2 COILS| THREE BOSTON SCIENTIFIC MATRIX2 COILS