BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

    MDR report key: 1771702 · Received July 28, 2010

    Report

    Report Number
    2134265-2010-03329
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS IN A FULLY DEPLOYED CONDITION WITHOUT THE STENT COMPONENT. NO ISSUES WERE NOTED WITH THE INNER LUMEN OF THE DELIVERY SYSTEM. A KINK WAS PRESENT IN THE BLUE OUTER SHEATH APPROXIMATELY 234MM DISTAL TO THE DISTAL END OF THE T-BAR CONNECTOR. THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. THERE WERE NO OTHER ISSUES NOTED WITH 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 A STENTING TREATMENT PROCEDURE, A PREMATURE STENT DEPLOYMENT OCCURRED. THE LESION SELECTED FOR TREATMENT WAS LOCATED IN THE ILIAC ARTERY. THIS 8X47X135 WALLSTENT WAS SELECTED FOR USE, HOWEVER, THE STENT PREMATURELY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT STATUS IS LISTED AS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A PREMATURE STENT DEPLOYMENT OCCURRED. THE LESION SELECTED FOR TREATMENT WAS LOCATED IN THE ILIAC ARTERY. THIS 8X47X135 WALLSTENT WAS SELECTED FOR USE, HOWEVER, THE STENT PREMATURELY DEPLOYED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT STATUS IS LISTED AS OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ILIAC ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712210 12864746

    Patients

    Seq Age Sex Outcome Treatment
    1