BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX2 DETACHABLE COIL

    MDR report key: 1020926 · Received March 27, 2008

    Report

    Report Number
    2939204-2008-00108
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 3, 2008
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE COIL LOOPS WERE PROTRUDING INTO THE PARENT VESSEL.

    Description of Event or Problem · 1

    A COILING PROCEDURE OF AN INTRACRANIAL ANEURYSM WAS REPORTED TO THE MANUFACTURER IN 2008. THE PATIENT CONDITION PRIOR TO THE PROCEDURE WAS HUNT AND HESS GRADE 4. WHILE THE PHYSICIAN WAS DEPLOYING A COIL INTO AN ANEURYSM, THE PHYSICIAN "SAW THAT THE COIL BECAME TANGLED WITH ANOTHER COIL THAT WAS ALREADY IN THE ANEURYSM." THE PHYSICIAN REMOVED THE COIL; HOWEVER, "LOOPS OF THE PREVIOUS COILS WERE DIPPING OUT OF THE ANEURYSM." THE PHYSICIAN SUCCESSFULLY DEPLOYED A STENT TO ADHERE THE COILS (ONE IS SUBJECT DEVICE) BACK INTO THE ANEURYSM. THE PATIENT CONDITION FOLLOWING THE PROCEDURE "WAS STILL GRADE 4 SIMILAR TO PRIOR TREATMENT; HOWEVER, THE ANEURYSM WAS SECURE WITH COILS AND STENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX2 DETACHABLE COIL HCG DEVICE, NEUROVASCULAR EMBOLIZATION HCG NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXCELSIOR SL10 MICROCATHETER| TWO MATRIX2 COILS