BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1692824 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00413
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    December 10, 2007
    Report Date
    October 23, 2007
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K050700 AND K031049. ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTION FOR USE. THE USE OF THE COIL CANNOT BE CONFIRMED TO HAVE HAD A CONTRIBUTORY FACTOR TO THE REPORTED PATIENT COMPLICATIONS. HOWEVER, THERE ARE MEDICAL AND PHYSIOLOGICAL FACTORS THAT CAN CONTRIBUTE TO RECANALIZATION AND IS LISTED AS A POTENTIAL COMPLICATION WITHIN THE DIRECTION FOR USE. ALSO, THE DIRECTION FOR USE (DFU) STATES THAT MULTIPLE EMBOLIZATION PROCEDURES MAY BE REQUIRED TO ACHIEVE THE DESIRED OCCLUSION OF SOME ANEURYSMS OR VESSELS. THEREFORE A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL COIL EMBOLIZATION OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. IMMEDIATELY AFTER TREATMENT THE SUBJECT WAS IMPROVED. FOUR DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED IN IMPROVED CONDITION AND WITH GOOD RECOVERY. PROGRAMMED FOLLOW UP PERFORMED APPROXIMATELY 90 DAYS POST EMBOLIZATION, DEMONSTRATED RECANALIZATION OF THE ANEURYSM WITH COIL COMPACTION. A SUCCESSFUL REINTERVENTION WAS PERFORMED 40 DAYS POST INDEX EVALUATION AND ANGIOGRAPHY PERFORMED APPROXIMATELY 130 DAYS POST REINTERVENTION REVEALED COMPLETE OCCLUSION OF THE ANEURYSM. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX DETACHABLE COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK UNK535

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 STANDARD 360 SR| (B) (4) - MATRIX2 STANDARD 360 SR| (2) (B) (4) - MATRIX2 ULTRASOFT SR| (B) (4) - MATRIX2 STANDARD 360 SR| (2) ULTIPAQ COILS (MICRUS)| GDC 10 STANDARD 360| (B) (4) - MATRIX2 SOFT 360 SR| (B) (4) - MATRIX2 SOFT 360 SR| BOSTON SCIENTIFIC EXCELSIOR SL10 MICROCATHETER| GDC STANDARD 360