BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1935931 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05484
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: ONLY THE DISTAL END OF THE INNER LUMEN OF THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS INSERTED THROUGH AN 8F NON-BSC INTRODUCER SHEATH. THE EXTERIOR RADIOPAQUE (RO) MARKERBAND HAD DETACHED FROM THE OUTER SHEATH AND WAS FREE MOVING ON THE INNER LUMEN BETWEEN THE STENT HOLDER AND THE STENT CUP. THE RO MARKERBAND APPEARED COMPRESSED. THE INNER LUMEN WAS KINKED 60MM PROXIMAL FROM THE TIP. THE STENT WIRES WERE DAMAGED AT ONE END. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DAMAGE NOTED TO THE ILIAC ARTERY WALL WAS NOT A DISSECTION. THE STENT BECAME STUCK IN THIS LOCATION WITH THE DAMAGED PROXIMAL STENT STRUTS IN THE VESSEL WALL. THE STENT COULD NOT BE MOVED FORWARD OR BACKWARD. THE PATIENT WAS NOT BLEEDING FROM THIS HOWEVER. ANGIOGRAPHY WAS PERFORMED AFTER THE STENTING PROCEDURE, AND IT SHOWED NO CONTRAST EXTRAVASATION, THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, AN RO MARKER BAND DETACHED. VASCULAR ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE PHYSICIAN WAS TREATING A "SIGNIFICANTLY STENOSED" SUBTOTAL OCCLUSION (98%), ECCENTRIC SHAPED, 20MM IN LENGTH, DE-NOVO LESION LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED, 8MM IN DIAMETER, RIGHT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS PRE-DILATED RESULTING IN 30% RESIDUAL STENOSIS. THIS 10.0-31 CAROTID WALLSTENT WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. DURING DEPLOYMENT OF THE STENT, THE DISTAL MARKER BAND DETACHED AFTER ONLY 4/5 OF THE STENT HAD BEEN DEPLOYED. THE STENT WAS UNABLE TO DEPLOY FULLY AND TOOK THE SHAPE OF AN HOURGLASS. THE PHYSICIAN ATTEMPTED TO RECONSTRAIN THE STENT, BUT WAS UNABLE TO. THE GUIDE CATHETER AND STENT DELIVERY SYSTEM (SDS) WERE WITHDRAWN TOGETHER FROM THE RIGHT ICA TO THE RIGHT EXTERNAL ILIAC ARTERY, WHERE THEY BECAME STUCK AT THE INTRODUCER SHEATH. IN ORDER TO REMOVE THE GUIDE CATHETER, THE PHYSICIAN CUT THE PROXIMAL END OF THE CAROTID WALLSTENT SDS. THE PHYSICIAN WAS ABLE TO REMOVE THE GUIDE WIRE AND GUIDE CATHETER, HOWEVER, THE INTRODUCER SHEATH AND THE DISTAL SECTION OF THE CAROTID WALLSTENT SDS WITH STENT REMAINED IN THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE VASCULAR SURGERY UNIT WHERE THE DEVICES WERE REMOVED FROM THE PATIENT. THE ILIAC ARTERY WALL WAS "DAMAGED" FROM THE PROXIMAL END OF THE STENT DURING REMOVAL REQUIRING A VENOUS PATCH APPROXIMATELY 6 HOURS AFTER THE PROCEDURE. NO STENT WAS IMPLANTED IN EITHER ICA. FOLLOW UP ON THE PATIENT SHOWED THAT THERE WAS NORMAL FLOW AND CONDITIONS IN THE RIGHT ICA. FUTURE STENTING OF THE ICA IS STILL IN DEBATE. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT IS STABLE AFTER VASCULAR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647130 13084820

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention GUIDE WIRE: TRANSEND FLOPPY 205 CM| 8F INTRODUCER SHEATH| GUIDE CATHETER: 8F CORDIS VISTA