BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ BILIARY RX STENT SYSTEM

    MDR report key: 4122159 · Received September 26, 2014

    Report

    Report Number
    3005099803-2014-03181
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K140630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION RESULTS: A WALLFLEX BILIARY STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY CONSTRAINED ON THE DELIVERY SYSTEM. THE CATHETER WAS FOUND KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE STAINLESS STEEL TUBE WAS KINKED AT 16CM DISTAL TO THE PROXIMAL EDGE OF THE TRAILING HANDLE. THE KINKS IDENTIFIED ALONG THE DEVICE ARE ALL CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DEVICE. THE INVESTIGATOR WAS ABLE TO RETRACT THE EXTERIOR TUBE AND FULLY DEPLOY THE STENT. NO SIGNIFICANT RESTRICTIONS WERE NOTED DURING THE DEPLOYMENT OF THE STENT. THE DEPLOYED STENT FULLY EXPANDED. NO DAMAGE WAS IDENTIFIED ALONG THE ENTIRE STENT. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT INCIDENT AS THE STENT WAS RECEIVED FULLY CONSTRAINED ON THE DELIVERY SYSTEM. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED 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

    INITIAL REPORTER: COMPLAINANT CITY AND PHYSICIAN'S ALTERNATIVE PHONE NUMBER: (B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 STENT WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A 3 CM MALIGNANT STRICTURE DUE TO PANCREATIC CANCER. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT; HOWEVER, IT WAS NOTED THAT THE STENT FAILED TO EXPAND. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A 3 CM MALIGNANT STRICTURE DUE TO PANCREATIC CANCER. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT; HOWEVER, IT WAS NOTED THAT THE STENT FAILED TO EXPAND. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601208 WALLFLEX¿ BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570540 0016175734

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention