BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 2020716 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-01012
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITHOUT THE STENT COMPONENT. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH HAD BEEN RETRACTED AND THE STENT HAD BEEN DEPLOYED FROM THE DEVICE. DRIED BLOOD WAS PRESENT INSIDE THE DISTAL END OF THE OUTER SHEATH. THE T-BAR CONNECTOR WAS DETACHED FROM THE SHRINK TUBING. THERE WAS EVIDENCE OF A FILLET OF GLUE PRESENT ON THE T-BAR CONNECTOR INDICATING THAT GLUE HAD BEEN APPLIED AS REQUIRED DURING MANUFACTURE. IT WAS NOTED THAT THE FILLET OF GLUE HAD DETACHED FROM THE DISTAL END OF THE SHRINK TUBING AND THE PROXIMAL END OF THE OUTER SHEATH. THE OUTER SHEATH WAS UNABLE TO BE MOVED PROXIMALLY OR DISTALLY. THE SHAFT WAS DISSECTED AND IT WAS NOTED THAT THE DRIED BLOOD WHICH WAS PRESENT INSIDE THE DISTAL END OF THE OUTER SHEATH WAS PREVENTING THIS MOVEMENT. THE BLOOD WAS REMOVED FROM THE DEVICE AND THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. 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 REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CAROTID ARTERY. THE PHYSICIAN SELECTED THIS 8.0X21MM CAROTID WALLSTENT FOR TREATMENT. DURING DEPLOYMENT OF THE STENT, THE HANDLE SEPARATED FROM THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS). THIS OCCURRED AS THE STENT WAS HALF DEPLOYED. DUE TO THIS, THE HALF DEPLOYED STENT COULD NOT BE DEPLOYED OR RECONSTRAINED. THE STENT THEN DISLODGED FROM THE SDS AND WAS RETRIEVED WITH A "LASSO". THE SDS WAS REMOVED WITH THE HELP OF A LONG INTRODUCER. THERE WAS NOTHING LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAROTID WALLSTENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647070 12632429

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention