BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID WALLSTENT?

    MDR report key: 4110633 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-06098
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE STENT WAS PARTIALLY DEPLOYED WITH ITS DISTAL STENT WIRES PROTRUDING FROM THE DISTAL END OF THE OUTER SHEATH. IT APPEARED THAT THE STENT HAD MOVED DISTALLY ALONG THE SHAFT AND ITS PROXIMAL END WAS NOT POSITIONED AT THE STENT CUP. DURING ANALYSIS WHEN THE OUTER WAS PARTIALLY RETRACTED AND AN ATTEMPT WAS MADE TO FULLY RECONSTRAIN THE STENT, THE STENT WAS NOT FULLY RECONSTRAINED DUE TO ITS DISTAL MOVEMENT ON THE SHAFT. THE STENT WAS THEN FULLY DEPLOYED AND NO ISSUES WERE NOTED WITH THE INNER LUMEN OR STENT CUP OR STENT HOLDER. NO ISSUES WERE NOTED WITH THE PROFILE OF THE STENT INCLUDING ITS LENGTH. SLIGHT BENDING OF THE METAL SHAFT WAS ALSO NOTED. THE DISTAL MOVEMENT OF THE STENT AND BEND IN THE METAL SHAFT IS CONSISTENT WITH EXCESSIVE HANDLING OF THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A STENTING TREATMENT PROCEDURE, PREMATURE STENT DEPLOYMENT OCCURRED. THE PHYSICIAN FLUSHED THE CAROTID WALLSTENT 10.0-24 OUTSIDE OF THE PATIENT WHEN IT WAS NOTICED THAT 1MM OF THE STENT DEPLOYED INSIDE THE OUTER SHEATH. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE STENT WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREP FOR A STENTING TREATMENT PROCEDURE, PREMATURE STENT DEPLOYMENT OCCURRED. THE PHYSICIAN FLUSHED THE CAROTID WALLSTENT 10.0-24 OUTSIDE OF THE PATIENT WHEN IT WAS NOTICED THAT 1MM OF THE STENT DEPLOYED INSIDE THE OUTER SHEATH. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE STENT WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590106 CAROTID WALLSTENT? STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647120 0016598145

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR