BEUDAMED
    FDA Adverse Event Death Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1654178 · Received April 8, 2010

    Report

    Report Number
    2134265-2010-01792
    Event Type
    Death
    Date Received
    April 8, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4)

    Description of Event or Problem · 1

    (B) (4) SAME CASE AS MFR REPORT #: 2134265-2010-01787. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CAROTID ARTERY INTERVENTION STENTING TREATMENT PROCEDURE, THE PATIENT DIED. THE INDEX PROCEDURE TREATED THE 98% STENOSED, 5.5X15MM TARGET LESION LOCATED IN THE LEFT OSTIUM INTERNAL CAROTID ARTERY. TREATMENT UTILIZED A BSC FILTERWIRE EZ AND PLACED A 10X24MM CAROTID WALLSTENT. FOLLOWING POST DILATION WITH AN UNSPECIFIED DEVICE THE RESIDUAL STENOSIS WAS 10%. APPROXIMATELY 10 MINUTES AFTER THE PROCEDURE, THE SUBJECT DEVELOPED EXPRESSIVE APHASIA AND RIGHT-SIDED WEAKNESS. HE WAS UNABLE TO FOLLOW COMMANDS WITH HIS RIGHT SIDE. A STAT CT OF THE HEAD WAS ORDERED THAT SHOWED A LARGE INTRACRANIAL BLEED. AFTER A DISCUSSION WITH HIS FAMILY, HE WAS MADE DNR. COMFORT MEASURES ONLY WERE ADMINISTERED. THE FOLLOWING DAY THE PATIENT DIED. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS CEREBRAL HERNIATION DUE TO THE CAUSE OF INTRACEREBRAL HEMORRHAGE. OTHER SIGNIFICANT CONDITIONS WERE CEREBRAL INFARCTION, CAROTID STENOSIS, ATRIAL FIBRILLATION, AND HYPERTENSION. AN AUTOPSY WAS NOT PERFORMED. NO FOLLOW-UP (B) (6) STROKE SCALES WERE PERFORMED. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900 0000920308

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H 8X24 CAROTID WALLSTENT