BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    MDR report key: 2013575 · Received March 10, 2011

    Report

    Report Number
    3005099803-2011-00774
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    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 MOUNTED ON THE DELIVERY SYSTEM AND A SEVERE KINK WAS PRESENT IN THE CATHETER NEAR THE GUIDEWIRE ACCESS PORT. IN ADDITION, THE OUTER SHEATH HAD SEPARATED BELOW THE PROXIMAL RELEASE HANDLE. ATTEMPTS TO RELEASE THE STENT WERE UNSUCCESSFUL. THE DEVICE WAS THEN DISSECTED JUST PROXIMAL TO THE GUIDEWIRE ACCESS PORT AND THE OUTER SHEATH WAS WITHDRAWN. THE STENT RELEASED WITH NO ISSUES NOTED. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE STENT FAILED TO DEPLOY AND THE OUTER SHEATH WAS DAMAGED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT ALL DEVICES SHIPPED FROM THE BATCH CONFORMED TO SPECIFICATIONS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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. A LABELING REVIEW IDENTIFIED THAT THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 RX FULLY COVERED BILIARY STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LOWER BILE DUCT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD UNDERGONE A PREVIOUS GASTROJEJUNOSTOMY, SO IT WAS DIFFICULT TO ADVANCE BOTH THE SCOPE AND STENT DELIVERY SYSTEM TO THE TARGET SITE. THE ANATOMY HAD NOT BEEN PREVIOUSLY DILATED. ONCE THE STENT HAD BEEN PROPERLY POSITIONED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO DEPLOY TO THE STENT. AFTER NUMEROUS ATTEMPTS, THE PHYSICIAN HEARD A STRANGE SOUND AND THE RESISTANCE DISAPPEARED; HOWEVER, THE STENT STILL COULD NOT BE DEPLOYED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED A TEAR IN THE OUTER SHEATH OF THE CATHETER. THE PHYSICIAN WAS ABLE TO USE ANOTHER TYPE OF STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX FULLY COVERED BILIARY STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LOWER BILE DUCT ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD UNDERGONE A PREVIOUS GASTROJEJUNOSTOMY, SO IT WAS DIFFICULT TO ADVANCE BOTH THE SCOPE AND STENT DELIVERY SYSTEM TO THE TARGET SITE. THE ANATOMY HAD NOT BEEN PREVIOUSLY DILATED. ONCE THE STENT HAD BEEN PROPERLY POSITIONED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT; HOWEVER, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO DEPLOY TO THE STENT. AFTER NUMEROUS ATTEMPTS, THE PHYSICIAN HEARD A STRANGE SOUND AND THE RESISTANCE DISAPPEARED; HOWEVER, THE STENT STILL COULD NOT BE DEPLOYED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED A TEAR IN THE OUTER SHEATH OF THE CATHETER. THE PHYSICIAN WAS ABLE TO USE ANOTHER TYPE OF STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00580320 13913924

    Patients

    Seq Age Sex Outcome Treatment
    1 VISIGLIDE 0.025INCH (OLYMPUS)| OLYMPUS JF-260V