BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

    MDR report key: 2022412 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00810
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K081733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY DEPLOYED FROM THE DELIVERY SYSTEM. IN ADDITION, THE DISTAL HANDLE HAD BEEN RETRACTED PAST THE RE-CONSTRAINMENT MARKER. NO OTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE STENT WAS PARTIALLY DEPLOYED. THE COMPLAINT WAS NOT CONFIRMED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNKNOWN, IT WAS REPORTED THAT THE PATIENT IS (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS POSITIONED WITHIN THE LEFT HEPATIC DUCT AND BILE DUCT. THE ANATOMY WAS NOT TORTUOUS; HOWEVER, THE LESION WAS PRE-DILATED. THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS DETERMINED THAT THE STENT WAS NOT IN THE DESIRED LOCATION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RE-CONSTRAIN THE STENT, DIFFICULTY WAS ENCOUNTERED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX UNCOVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS POSITIONED WITHIN THE LEFT HEPATIC DUCT AND BILE DUCT. THE ANATOMY WAS NOT TORTUOUS; HOWEVER, THE LESION WAS PRE-DILATED. THE STENT WAS PARTIALLY DEPLOYED WHEN IT WAS DETERMINED THAT THE STENT WAS NOT IN THE DESIRED LOCATION. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RE-CONSTRAIN THE STENT, DIFFICULTY WAS ENCOUNTERED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX UNCOVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580020 13573700

    Patients

    Seq Age Sex Outcome Treatment
    1