BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1812841 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03796
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER. AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME PATIENT AS 2134265-2010-03795. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A STROKE. THE TARGET LESION WAS LOCATED IN THE LEFT OSTIUM INTERNAL CAROTID WITH AN 80% STENOSIS THAT WAS 20 MM LONG WITH A 5 MM REFERENCE VESSEL DIAMETER. THE PHYSICIAN TREATED THE LESION WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 5%. THREE DAYS LATER THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT WAS STILL HOSPITALIZED WHEN THE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT WHILE AT HOME FOLLOWING THE INDEX PROCEDURE, FOR LEFT CAROTID STENTING, THE PATIENT WAS NOTED TO HAVE MILD MENTAL STATUS AND SPEECH IMPAIRMENT. THE PATIENT BECAME MORE OBTUNDED AND CONFUSED. HE WAS TAKEN BACK TO THE HOSPITAL AND WAS FOUND TO HAVE A BLOOD SUGAR OF 700 AND DIABETIC KETOACIDOSIS. THIS WAS RESOLVED BUT HE WAS LEFT WITH A SPEECH IMPAIRMENT. THE PATIENT WAS SEEN BY NEUROLOGY. CLINICAL IMPRESSIONS SUGGESTED THE PATIENT HAD AN AREA OF CEREBRAL ISCHEMIA IN THE MIDDLE CEREBRAL ARTERY. THE NEXT DAY, A NON CONTRAST CT SCAN OF THE BRAIN SHOWED THAT SINCE THE PATIENT¿S INDEX PROCEDURE THERE HAS BEEN INTERVAL DEVELOPMENT OF A SMALL FOCAL AREA OF LUCENCY WITHIN THE DEEP LEFT FRONTAL LOBE WHITE MATTER, LIKELY REPRESENTING AN EVOLVING LACUNAR-TYPE INFARCTION. THERE ARE ALSO MULTIPLE AREA OF CALCIFICATION IDENTIFIED WITHIN THE BRAIN SUBSTANCE, ESSENTIALLY UNCHANGED RELATIVE TO NUMEROUS PRIOR CT STUDIES. THE PATIENT'S CONDITION IMPROVED AND HE WAS DISCHARGED 3 DAYS AFTER ADMISSION AND WAS PROVIDED WITH PHYSICAL, OCCUPATIONAL AND SPEECH THERAPY. HE WILL FOLLOW-UP WITH HIS PRIMARY CARE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719020 12254700

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization FILTERWIRE EZ