BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 1914123 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-04984
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE INNER LUMEN WAS BROKEN AT 250MM PROXIMAL TO ITS DISTAL END. THE TIP WAS FULLY ATTACHED TO THE INNER LUMEN AND THE INNER LUMEN WAS KINKED AT 102MM FROM THE DISTAL TIP. THE DISTAL HANDLE AND OUTER SHEATH WAS FULLY RETRACTED INDICATING THAT THE OUTER SHEATH HAD NOT BEEN CLOSED TO THE TIP PRIOR TO WITHDRAWAL OF THE DEVICE. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT. THE TIP HAD NOT DETACHED FROM THE DEVICE HOWEVER, THE INNER LUMEN HAD BROKEN. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DETACHED DEVICE FRAGMENT 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED DURING A BILIARY STENTING PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A FOUR TO FIVE CENTIMETER LESION IN THE MID COMMON BILE DUCT, AS A RESULT OF A MALIGNANT TUMOR. THE ANATOMY WAS NOT TORTUOUS, NOR DILATED PRIOR TO THE PROCEDURE. FOLLOWING STENT DEPLOYMENT, IT WAS REPORTED THAT THE STENT WAS FULLY EXPANDED; HOWEVER THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DELIVERY SYSTEM. THE DISTAL TIP OF THE DELIVERY SYSTEM DETACHED, AND REMAINED IN THE PATIENT. THE PHYSICIAN DOES NOT BELIEVE THAT THE DELIVERY SYSTEM CAUGHT ON ANOTHER DEVICE SUCH AS THE ENDOSCOPE. A BASKET AND BALLOON WERE USED TO SUCCESSFULLY RETRIEVED THE REMAINING PART OF THE DELIVERY SYSTEM FROM THE PATIENT. ALTHOUGH THE PHYSICIAN WAS HAPPY WITH THE POSITIONING OF THE STENT, A SECOND WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED DURING A BILIARY STENTING PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A FOUR TO FIVE CENTIMETER LESION IN THE MID COMMON BILE DUCT, AS A RESULT OF A MALIGNANT TUMOR. THE ANATOMY WAS NOT TORTUOUS, NOR DILATED PRIOR TO THE PROCEDURE. FOLLOWING STENT DEPLOYMENT, IT WAS REPORTED THAT THE STENT WAS FULLY EXPANDED; HOWEVER, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE DELIVERY SYSTEM. THE DISTAL TIP OF THE DELIVERY SYSTEM DETACHED, AND REMAINED IN THE PATIENT. THE PHYSICIAN DOES NOT BELIEVE THAT THE DELIVERY SYSTEM CAUGHT ON ANOTHER DEVICE SUCH AS THE ENDOSCOPE. A BASKET AND BALLOON WERE USED TO SUCCESSFULLY RETRIEVE THE REMAINING PART OF THE DELIVERY SYSTEM FROM THE PATIENT. ALTHOUGH THE PHYSICIAN WAS HAPPY WITH THE POSITIONING OF THE STENT, A SECOND WALLFLEX BILIARY RX UNCOVERED STENT WAS IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570650 13492066

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention