BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1756555 · Received July 14, 2010

    Report

    Report Number
    2939204-2010-00800
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA # OR 510 #: K050700 AND K031049.

    Additional Manufacturer Narrative · 1

    CONCLUSION: ANTICIPATED PROCEDURAL COMPLICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR ALL THE IMPLANTED COILS AND THIS CONFIRMED THAT ALL THE BATCHES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. ANEURYSM RUPTURE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE ANEURYSM RUPTURE WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE REPORTED COIL PROTRUSION WAS DETERMINED TO BE MOST LIKELY RELATED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    AT A ROUTINE FOLLOW-UP VISIT THREE MONTHS AFTER THE INDEX PROCEDURE, IT WAS NOTED THAT A LOOP OF A PREVIOUSLY PLACED COIL WAS PROTRUDING FROM THE ANEURYSM. IT WAS REPORTED THAT "THE LOOP OF COIL PROLAPSED AS THE ANEURYSM WALL WAS RUPTURED BY THE COIL'S TENSION." IT IS UNKNOWN WHEN THE RUPTURE OCCURRED, THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN TOOK NO ACTION TO DEAL WITH THE EVENT AND THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    AT A ROUTINE FOLLOW-UP VISIT THREE MONTHS AFTER THE INDEX PROCEDURE, IT WAS NOTED THAT A LOOP OF A PREVIOUSLY PLACED COIL WAS PROTRUDING FROM THE ANEURYSM. IT WAS REPORTED THAT "THE LOOP OF COIL PROLAPSED AS THE ANEURYSM WALL WAS RUPTURED BY THE COIL'S TENSION." IT IS UNKNOWN WHEN THE RUPTURE OCCURRED, THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN TOOK NO ACTION TO DEAL WITH THE EVENT AND THERE WAS NO 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 Other TWO GDC COIL (BOSTON SCIENTIFIC)| THREE MATRIX 2 COIL (BOSTON SCIENTIFIC)| FOUR ED COILS (MANUFACTURER UNKNOWN)