BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1811754 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03637
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)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)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED RIGHT UPPER EXTREMITY WEAKNESS WITH THE ISCHEMIC STROKE. THE PATIENT HAD VARIABLE EPISODES OF WAXING AND WANING. THE DISCHARGE SUMMARY NOTED THE PATIENT RECEIVED 2 UNITS OF BLOOD 2 TIMES. THE PATIENT WAS DISCHARGED TO A REHAB FACILITY AND WILL FOLLOW UP WITH HER DOCTORS FOR FURTHER MEDICAL MANAGEMENT.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-03636. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANEMIA, A GROIN PSEUDOANEURYSM AND ISCHEMIC STROKE. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 9X15MM TARGET LESION LOCATED IN THE LEFT OSTIUM INTERNAL CAROTID ARTERY. TREATMENT UTILIZED AT THE INDEX PROCEDURE TREATED THE 80% STENOSED, 9X15MM 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 0%. FOLLOWING THE PROCEDURE THE SAME DAY, THE PATIENT HAD ANEMIA AND RECEIVED UNITS OF BLOOD. THE FOLLOWING DAY, THE PATIENT HAD AN ISCHEMIC STROKE. A POST-PROCEDURE NEUROLOGICAL EXAM FOUND THE SUBJECT TO BE VERY LETHARGIC AND HAD SOME MINOR MENTAL STATUS CHANGES. A NEUROLOGY CONSULT WAS ORDERED BUT A CAT OF THE HEAD WAS NOT NECESSARY. A FEW HOURS LATER, A REPEAT NEUROLOGICAL EXAM WAS PERFORMED. HEMOGLOBIN AND HEMATOCRIT LEVELS WERE UP. SHORTLY AFTER THIS, THE PATIENT COMPLAINED OF HAVING PAIN IN HER RIGHT GROIN, FLANK AND BACK AND A THROMBIN INJECTION WAS ADMINISTERED. THE PRINCIPAL INVESTIGATOR WAS NOTIFIED AND THE PATIENT UNDERWENT A CAT SCAN WHICH RULED OUT ANY RETROPERITONEAL BLEED OR HEMORRHAGE. LATER THAT EVENING, THE PATIENT AGAIN HAD SHORT PERIODS OF CONFUSION. THE PRINCIPAL INVESTIGATOR WAS AGAIN NOTIFIED AND A CT OF THE HEAD WAS ORDERED. ON DAY TWO, THE NEUROLOGICAL STATUS REPORTED NO PROBLEMS OR COMPLICATIONS. THE PATIENT WAS DISCHARGED ON DAY 4. PER THE PHYSICIAN THE STUDY DEVICES WERE LISTED AS "POSSIBLY RELATED' TO THE EVENTS. ON DAY 9, A G.I. BLEED WAS REPORTED. A COLONOSCOPY WITH BIOPSY WAS PERFORMED. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. PER THE PHYSICIAN, IT WAS UNRELATED TO THE FILTERWIRE EZ OR THE CAROTID WALLSTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719040 12247246

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R FILTERWIRE EZ