BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING MONORAIL

    MDR report key: 957015 · Received November 30, 2007

    Report

    Report Number
    6000093-2007-02237
    Event Type
    Injury
    Date Received
    November 30, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 1, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF ANY ADD'L RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SAME CASE AS MFR'S REPORT # 600093-2007-02235, 2954755-2007-00046, 6000093-2007-02234, 6000093-2007-02236. IT WAS REPORTED THAT FOLLOWING A CAROTID STENTING TREATMENT PROCEDURE, STENT THROMBOSIS OCCURRED RESULTING IN A STROKE FOR THE PT. THE PT ORIGINALLY PRESENTED WITH HEMISPHERIC TRANSIENT ISCHEMIC ATTACKS (TIAS) WITH ALTERNATING WEAKNESS OF BOTH UPPER EXTREMITIES. CAROTID DUPLEX IMAGING AND COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAPHY CONFIRMED BILATERAL INTERNAL CAROTID ARTERY (ICA) STENOSIS. SEVERAL WEEKS AGO, A HIGH-GRADE ICA STENOSIS WAS REPAIRED VIA OPEN CAROTID ENDARTERECTOMY (OCE). THE PT IS NOW HAVING A STENT PLACEMENT IN THE RIGHT ICA AS CT ANGIOGRAPHY CONFIRMED THAT THIS LESION WAS LOCATED ABOVE THE C2 LEVEL MAKING THIS A HIGH-RISK PT FOR OCE. THE PT HAS BEEN MAINTAINED ON PLAVIX ANTIPLATELET THERAPY SINCE HIS OCE SURGERY. THE PHYSICIAN USED A RIGHT COMMON FEMORAL ARTERY (CFA) ACCESS SITE AND PERFORMED ANGIOGRAPHIC STUDIES AS NOTED BELOW. HE SUBSEQUENTLY USED AN AMPLATZ 0.035"/180 CM GUIDE WIRE PLACED IN THE EXTERNAL CAROTID ARTERY AND DELIVERED A 6F/90 CM INTRODUCER SHEATH TO THE DISTAL COMMON CAROTID ARTERY (CCA) PROXIMAL TO THE CAROTID BULB. A 3.5-5.5 FILTERWIRE EZ WAS DELIVERED THROUGH THE 6F SHEATH TO THE DISTAL ICA AND POSITIONED WITHIN THE CAVERNOUS PORTION OF THE ICA AND DEPLOYED. THROUGHOUT THE PROCEDURE, THE FILTERWIRE WAS MAINTAINED IN THIS POSITION WITH MINIMAL MOVEMENT. A 3X20 STERLING BALLOON WAS PREPPED AND DELIVERED UNDER FLUOROSCOPIC GUIDANCE ACROSS THE ICA STENOSIS AND INFLATED TO 6 ATMS FOR 5 SECONDS AND RAPIDLY DEFLATED. THE PT REMAINED ASYMPTOMATIC DURING THIS INTERVENTION. UPON REMOVAL OF THE STERLING BALLOON AFTER PREDILATATION, THE FILTERWIRE RETRACTED ABOUT 15 MM. THE PHYSICIAN REPOSITIONED THE FILTERWIRE BY PUSHING IT BACK INTO PLACE. SUBSEQUENTLY, A 4-9X30 MM NEXSTENT WAS PREPPED AND DELIVERED IN A RAPID EXCHANGE FASHION OVER THE GUIDE WIRE TO THE LESION. PROPER STENT POSITIONING WAS CONFIRMED VIA ANGIOGRAPHY. THE DISTAL ICA AND FILTERWIRE REMAINED PATENT. THE NEXSTENT WAS DEPLOYED WITH SATISFACTORY COVERAGE OF THE ICA LESION. UPON REMOVAL OF THE NEXSTENT HOUSING, THE FILTERWIRE MOVED ABOUT 15MM AGAIN. THE PHYSICIAN REPOSITIONED THE FILTERWIRE BY PUSHING IT BACK INTO PLACE. A 4X20 MM STERLING BALLOON WAS PLACED ACROSS THE STENT AND INFLATED TO 6 ATMS FOR 5 SECONDS FOR POST-DILATATION. THE PHYSICIAN THEN POST-DILATED WITH A 5X2 STERLING BALLOON. WHEN ADVANCING THE 5X20 STERLING BALLOON, HE PULLED THE FILTERWIRE COMPLETELY INTO THE GUIDE SHEATH AND THEN REMOVED LEAVING ONLY THE GUIDE SHEATH. FOLLOW-UP ANGIOGRAPHY OF THE CERVICAL CAROTID AND THE RIGHT CEREBRAL HEMISPHERE WAS PERFORMED SHOWING NO EVIDENCE OF INTRACRANIAL OR CERVICAL THROMBUS AS WELL AS INTACT ANTERIOR CIRCULATION WITHOUT EVIDENCE OF THROMBOSIS. THE 6F SHEATH WAS REMOVED OVER A STIFF GUIDEWIRE AND EXCHANGED FOR A SHORT 6F SHEATH, WHICH WAS SUTURED IN PLACE TO MAINTAIN VESSEL ACCESS. AN ANGIOMAX BOLUS AND INFUSION OF STANDARD DOSING WERE PERFORMED AT THE TIME THAT THE GUIDE WIRE MANIPULATION WAS INITIATED IN THE INFRARENAL ABDOMINAL AORTA. THE ACTIVATED CLOTTING TIME (ACT) WAS DRAWN AND FOUND TO BE IN EXCESS OF 400. THE ANGIOMAX INFUSION WAS CONTINUED FOR 30 MINUTES FOLLOWING COMPLETION OF THE PROCEDURE. THE PT WAS HEMODYNAMICALLY STABLE, AWAKE, ALERT, AND MOVING ALL EXTREMITIES AT THE CONCLUSION OF THE PROCEDURE. THREE HOURS POST-PROCEDURE, THE PT BEGAN HAVING VISUAL SYMPTOMS. A CT ANGIOGRAM REVEALED THAT THE PT HAD A THROMBOSIS OF THE DISTAL PORTION OF THE NEXSTENT INTO THE CAVERNOUS ICA. A REPEAT CT SCAN WAS PERFORMED THE NEXT DAY, AND REVEALED A MODERATE RIGHT MIDDLE CEREBRAL ARTERY (MCA) STROKE. THE PT IS CURRENTLY STABLE, UP AND WALKING, BUT HAVING VISUAL COMPLICATIONS. THE PT IS HIGH RISK FOR SURGERY. ADD'L INFO HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O 6F/90 CM TERUMO INTRODUCER SHEATH