BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATRIX STRETCH RESISTANT (SR) COILS

    MDR report key: 1693351 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00341
    Event Type
    Death
    Date Received
    May 18, 2010
    Date of Event
    August 18, 2007
    Report Date
    August 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K050700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. THE SUBJECT DEVICE REMAINED IMPLANTED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, IT WAS DETERMINED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE DIRECTION FOR USE, AND THAT THE PATIENT PRESENTED A PRE EXISTING CONDITION PRIOR TO THE PROCEDURE. THEREFORE, THE USE OF THE COIL MAY HAVE HAD A CONTRIBUTORY FACTOR TO THE REPORTED PATIENT¿S COMPLICATIONS. HOWEVER, EMBOLI (FOREIGN, THROMBOEMBOLIC), ISCHEMIA AND THE PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ANEURYSM COILING PROCEDURES AND NOTED AS SUCH IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT COIL EMBOLIZATION OF THE LEFT CAROTID ARTERY ANEURYSM THAT RESULTED IN PARTIAL OCCLUSION OF THE ANEURYSM. IMMEDIATELY AFTER PROCEDURE, THE SUBJECT¿S CONDITION WORSENED DUE TO AN EMBOLISM WITH RESULTANT ISCHEMIA. IT WAS REPORTED THAT DURING THE INDEX HOSPITALIZATION, THE PATIENT SUFFERED A PULMONARY INFECTION THAT RESULTED IN DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRIX STRETCH RESISTANT (SR) COILS DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M003497203SR0

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| O MICROCATHETER (UNKNOWN MANUFACTURER)| 2 MATRIX COILS (BOSTON SCIENTIFIC)