BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1812742 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03886
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION BY MANUFACTURER: A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. THERE WAS DRIED BLOOD ALONG THE SHAFT AND THE SHAFT WAS BENT PROXIMAL TO THE MOUNTED STENT. DURING ANALYSIS WHEN AN ATTEMPT WAS MADE TO RETRACT THE OUTER SHEATH A RESTRICTION WAS MET. THE SHAFT WAS DISSECTED PROXIMAL TO THE MONORAIL EXIT AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. SOME RESISTANCE WAS MET WHEN WITHDRAWING THE INNER LUMEN FROM THE OUTER SHEATH DUE TO THE DRIED BLOOD ALONG THE SHAFT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, STENT DEPLOYMENT AND POSITIONING DIFFICULTY OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS CAROTID ARTERY. THE LESION WAS PREDILATED WITH 30X2MM STERLING BALLOON. THE CAROTID WALLSTENT 8X29MM WAS ADVANCED TO THE LESION AND PLACED. THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT AND "RECAPTURED" THE STENT. THE STENT WAS REPOSITIONED AND DEPLOYMENT DIFFICULTY WAS NOTED. THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, STENT DEPLOYMENT AND POSITIONING DIFFICULTY OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS CAROTID ARTERY. THE LESION WAS PREDILATED WITH A 30X2MM STERLING BALLOON. THE CAROTID WALLSTENT 8X29MM WAS ADVANCED TO THE LESION AND PLACED. THE PHYSICIAN WAS NOT SATISFIED WITH THE PLACEMENT AND "RECAPTURED" THE STENT. THE STENT WAS REPOSITIONED AND DEPLOYMENT DIFFICULTY WAS NOTED. THE STENT WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719020 12585396

    Patients

    Seq Age Sex Outcome Treatment
    1