BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 3062240 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02890
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P980033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEUNG KUG BAIK, MD, "WHAT IS THE REAL RISK OF DISLODGING THROMBI DURING ENDOVASCULAR REVASCULARIZATION OF A PROXIMAL INTERNAL CAROTID ARTERY OCCLUSION?" , CONGRESS OF NEUROLOGICAL SURGEONS, 2011. DEVICE EVALUATED BY MFR: 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

    SAME ARTICLE AS MDR#2134265-2013-02886, 2134265-2013-02895, AND 2134265-2013-02796. SAME CASE AS MDR#2134265-2013-02895. IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DURING A CAROTID ARTERY STENTING (CAS) PROCEDURE, A CEREBRAL INFARCTION OCCURRED. THE PATIENT PRESENTED WITH SEGMENTAL OCCLUSION OF THE PROXIMAL INTERNAL CAROTID ARTERY (ICA) AND AN INTRACEREBRAL THROMBUS IN THE MIDDLE CEREBRAL ARTERY (MCA). DIAGNOSTIC ANGIOGRAMS OF BOTH THE COMMON CAROTID ARTERY, OR ICA, AND BOTH VERTEBRAL ARTERIES WERE INITIALLY PERFORMED TO CONFIRM THE PRESENCE OF AN OCCLUSION AND EVALUATE THE RETROGRADE FILLING OF THE CERVICAL ICA. THE LUMINAL DIAMETER OF THE CERVICAL ICA WAS ALSO ANALYZED. CAS WAS PERFORMED UNDER LOCAL ANESTHESIA AND FULL ANTICOAGULATION, A 3000 TO 5000 IU BOLUS OF HEPARIN (50 IU/KG OF BODY WEIGHT), FOLLOWED BY CONTINUOUS INFUSION OF 1000 TO 2000 IU OF HEPARIN PER HOUR TO DOUBLE THE BASELINE ACTIVATED CLOTTING TIME. AN UNSPECIFIED 8F CEREBRAL GUIDING CATHETER WAS INTRODUCED INTO THE ICA VIA THE TRANSFEMORAL ROUTE UNILATERALLY. THE ORIGIN OF THE OCCLUDED ICA WAS GENTLY PROBED WITH A FILTERWIRE EZ DISTAL PROTECTION DEVICE AND WHEN NO RESISTANCE WAS ENCOUNTERED, THE DEVICE WAS GENTLY ADVANCED INTO THE HIGH CERVICAL ICA. AFTER PLACEMENT OF THE FILTERWIRE EZ, THE PROXIMAL ICA OCCLUSION SEGMENT WAS PREDILATED WITH A 2-3MM NON-BSC CORONARY BALLOON. THE SELF-EXPANDING 9 X 40MM WALLSTENT WAS THEN PLACED ACROSS THE OCCLUSION, FOLLOWED BY POSTDILATION USING A 4 TO 6MM NON-BSC BALLOON. A FINAL IPSILATERAL CAROTID ANGIOGRAM WAS PERFORMED TO CONFIRM REESTABLISHMENT OF ANTEGRADE FLOW AND TO EVALUATE THE LUMINAL DIAMETER OF THE DISTAL PROTECTION DEVICE DEPLOYMENT AREA IN THE CERVICAL ICA. FINAL RESIDUAL STENOTIC DIAMETER WAS LESS THAN 20%, AND THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) ANTEGRADE FLOW GRADE 3. SUCCESSFUL RECANALIZATION OF THE OCCLUDED PROXIMAL ICA SEGMENT WAS ACHIEVED. THERE WAS NO VESSEL PERFORATION OR EXTRAVASATION. ON THE POSTPROCEDURAL DIFFUSION-WEIGHTED IMAGE (DWI) THE PATIENT DEVELOPED NEW FOCAL BRAIN LESIONS; SMALL INFARCTIONS IN THE MIDDLE CEREBRAL ARTERY (MCA) TERRITORY OR BORDER ZONE. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED 100 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL DAILY FOR 1 YEAR. IN ADDITION, LOW-MOLECULAR WEIGHT HEPARIN (2850 IU/0.3 ML) WAS SUBCUTANEOUSLY ADMINISTERED TWICE DAILY FOR 2 DAYS. IN CONCLUSION, THE ARTICLE STATES THE REAL RISK OF DISLODGING THROMBI APPEARS TO BE DUE TO PLAQUE FRAGMENT MOBILIZATION BY ANGIOPLASTY RATHER THAN TO CROSSING AN OCCLUDED SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163700 WALLSTENT (ILIAC, TIPS, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY UNK679

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other AMILA 4-6MM BALLOON| SPRINTER 2-3MM BALLOON| FILTERWIRE EZ