BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? BILIARY RX STENT SYSTEM

    MDR report key: 4243317 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03600
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K140630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. (B)(4) STENT POSITIONING/PLACEMENT PROBLEM. (B)(4) STENT COVER DAMAGE. (B)(4) FOREIGN MATERIAL IN THE STENT. 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND OUT THAT THE STENT AND THE DELIVERY SYSTEM WERE RETURNED. THE STENT WAS DEPLOYED AND BROKEN IN THE INNER SECTION. THE DISTAL HANDLE WAS NOTED TO BE FULLY RETRACTED. DURING THE PRODUCT ANALYSIS, THE INVESTIGATOR NOTED THAT THE OUTER SHEATH WAS KINKED AT EACH SIDE OF THE TRANSITION SECTION AND A SERIES OF KINKS WERE ALSO NOTED ALONG THE CLEAR OUTER SHEATH. NO ISSUE WAS OBSERVED DURING MOVEMENT OF THE OUTER SHEATH ALONG THE SHAFT. THE INVESTIGATOR NOTED THAT THE INNER LUMEN WAS BROKEN AT 295MM FROM ITS DISTAL END AND WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE STENT COVER WAS TORN FOR A DISTANCE OF 2MM AT THE RETRIEVAL LOOP END. NO OTHER ISSUES WERE NOTED WITH THE STENT COVER OR PROFILE OF THE STENT AND NO FOREIGN MATERIAL WAS IDENTIFIED OR RETURNED. THE TEAR IN THE STENT COVER MAY HAVE OCCURRED DURING REMOVAL OF THE STENT USING THE FORCEPS. A REVIEW OF THE PHOTO ATTACHED TO THE COMPLAINT SHOWED A RECTANGULAR PIECE OF MATERIAL IN A CONTAINER ALONG WITH THE STENT. THIS MATERIAL WAS NOT RETURNED FOR ANALYSIS. HOWEVER IT COULD BE CONCLUDED THAT THIS MATERIAL IS NOT PART OF THE RETURNED STENT AS NO PART OF THE STENT COVER HAD DETACHED. THE NOTED DAMAGE WAS LIKELY DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT 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 LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 20, 2014 THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT AN OBSTRUCTION DUE TO PANCREATIC CANCER. REPORTEDLY, THE STRICTURE WAS NOT PRE DILATED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET AREA AND DEPLOYED THE STENT, HOWEVER, THE STENT WAS TOO PROXIMAL IN THE DUCT. THE PHYSICIAN ATTEMPTED TO USE FORCEPS TO PULL THE STENT DISTALLY INTO THE CORRECT POSITION BUT THE STENT WOULD NOT MOVE. AFTER SEVERAL ATTEMPTS, THE STENT FINALLY BUDGED BUT IT CAME OUT OF THE BILE DUCT. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT AND A FOREIGN OBJECT CAME OUT OF BILE DUCT WITH IT. AS REPORTED, THE PHYSICIAN ASSUMED THAT IT WAS PART OF THE PERMALUME COATING, THAT THE COATING WAS DAMAGED AND PERHAPS THE COVER DAMAGE WAS WHY THE STENT WAS UNABLE TO BE REPOSITIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX COVERED STENT. 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 ON (B)(6) 2014 THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE STENT WAS USED TO TREAT AN OBSTRUCTION DUE TO PANCREATIC CANCER. REPORTEDLY, THE STRICTURE WAS NOT PRE DILATED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE DEVICE TO THE TARGET AREA AND DEPLOYED THE STENT, HOWEVER, THE STENT WAS TOO PROXIMAL IN THE DUCT. THE PHYSICIAN ATTEMPTED TO USE FORCEPS TO PULL THE STENT DISTALLY INTO THE CORRECT POSITION BUT THE STENT WOULD NOT MOVE. AFTER SEVERAL ATTEMPTS, THE STENT FINALLY BUDGED BUT IT CAME OUT OF THE BILE DUCT. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT AND A FOREIGN OBJECT CAME OUT OF BILE DUCT WITH IT. AS REPORTED, THE PHYSICIAN ASSUMED THAT IT WAS PART OF THE PERMALUME COATING, THAT THE COATING WAS DAMAGED AND PERHAPS THE COVER DAMAGE WAS WHY THE STENT WAS UNABLE TO BE REPOSITIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX COVERED STENT. 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
    726034 WALLFLEX? BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570530 0017287467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention