BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIX DETACHABLE COILS

    MDR report key: 1775382 · Received July 29, 2010

    Report

    Report Number
    2939204-2010-00857
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    May 4, 2009
    Report Date
    July 19, 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 510K# - K050700. (B)(4): OTHER FOR 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. HEADACHE 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 REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    PMA# OR 510K# - K050700.

    Description of Event or Problem · 1

    NINETY POST STENT ASSISTED EMBOLIZATION OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A HEADACHE. A CT SCAN TAKEN AT THIS TIME REVEALED NO ANOMALIES THAT MIGHT ACCOUNT FOR THE HEADACHE. THE PATIENT WAS GIVEN 20MG OF METOCLOPRAMIDE AND 25MG OF DIPHENHYDRAMINE INTRAVENOUSLY AND WAS GIVEN 75MG OF TOPAMAX WITH INSTRUCTIONS TO TAKE UP TO 100MG FOR THE FOLLOWING SEVEN DAYS. THE HEADACHE WAS REPORTED TO BE RESOLVED THE SAME DAY. NINETY THREE DAYS POST PROCEDURE, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A HEADACHE. A CT SCAN TAKEN AT THIS TIME REVEALED NO ANOMALIES THAT MIGHT ACCOUNT FOR THE HEADACHE. THE PATIENT WAS GIVEN A 25MG INJECTION OF PHENERGAN (25MG/ML). THE HEADACHE WAS REPORTED TO BE RESOLVED THE SAME DAY WITH NO RESIDUAL EFFECT.

    Description of Event or Problem · 1

    NINETY POST STENT ASSISTED EMBOLIZATION OF THE RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A HEADACHE. AT CT SCAN TAKEN AT THIS TIME REVEALED NO ANOMALIES THAT MIGHT ACCOUNT FOR THE HEADACHE. THE PATIENT WAS GIVEN 20MG OF METOCLOPRAMIDE AND 25MG OF DIPHENHYDRAMINE INTRAVENOUSLY AND WAS GIVEN 75MG OF TOPAMAX WITH INSTRUCTIONS TO TAKE UP TO 100MG FOR THE FOLLOWING SEVEN DAYS. THE HEADACHE WAS REPORTED TO BE RESOLVED THE SAME DAY. NINETY THREE DAYS POST PROCEDURE, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A HEADACHE. AT CT SCAN TAKEN AT THIS TIME REVEALED NO ANOMALIES THAT MIGHT ACCOUNT FOR THE HEADACHE. THE PATIENT WAS GIVEN A 25MG INJECTION OF PHENERGAN (25MG/ML). THE HEADACHE WAS REPORTED TO BE RESOLVED THE SAME DAY WITH NO RESIDUAL EFFECT.

    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 41 YR Required Intervention NEUROFORM STENT (BOSTON SCIENTIFIC)| TWO MATRIX 2 COILS (BOSTON SCIENTIFIC)