WallFlex™ Biliary M00570540Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729764922), received between Dec 7, 2016 and Nov 18, 2025 — classified as 21 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS NOT COMPLETED AS THE SAME DEVICE WAS UNAVAILABLE, AND THE PATIENT WAS SHIFTED TO SURGICAL TREATMENT AS AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585648 ↗
• InjuryJul 11, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT FULLY EXPAND WHEN DEPLOYED INSIDE THE PATIENT. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484344 ↗
• InjuryApr 17, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO THE BILE DUCT TO TREAT A MALIGNANCY CAUSED BY CANCER DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE STENT HAS BEEN DEPLOYED HOWEVER IT DID NOT EXPAND COMPLETELY AND REMAINED COLLAPSED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858127 ↗
• InjuryNov 13, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT WAS USED TO TREAT A BILIARY STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, IT DID NOT EXPAND. THE STENT WAS SUBSEQUENTLY REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672838 ↗
• InjuryMar 15, 2024Positioning Failure; Material Deformation; Activation Failure; Positioning Failure; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY COVERED STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT EXPAND. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912963 ↗
• MalfunctionJun 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, SHORTENING WAS TOO SEVERE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: AS IT IS UNCLEAR FROM THE INFORMATION AVAILABLE WHAT THE FAILURE WAS AND ATTEMPTS TO OBTAIN DETAILS REGARDING THE EVENT HAVE BEEN UNSUCCESSFUL, THE REPORTED EVENT OF "SHORTENING WAS TOO SEVERE" WILL BE ASSESSED AS "STENT MATERIAL DEFORMATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098403 ↗
• InjuryMay 15, 2023Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 24, 2023 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A 2-3 CM BENIGN STRICTURE FOR BILIARY DRAINAGE WITH STONE EXTRACTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AFTER THE STENT WAS IMPLANTED, THE STENT COVER RUPTURED, AND SEVERAL HOLES WERE NOTED UNDER THE SCOPE. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A 2-3 CM BENIGN STRICTURE FOR BILIARY DRAINAGE WITH STONE EXTRACTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. HOWEVER, THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936072 ↗
• MalfunctionOct 5, 2022Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A CHOLANGIOCARCINOMA DURING A PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT DID NOT DEPLOY INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT COVER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543499 ↗
• MalfunctionOct 14, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 21, 2020 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE IMPLANTED TO TREAT A BILIARY TRACT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A PINHOLE WAS NOTED ON THE STENT COVER. THE STENT WAS NOT INTRODUCED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678079 ↗
• MalfunctionSep 8, 2020Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT BILE DUCT CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY INSIDE THE PATIENT'S BILE DUCT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER WAS DAMAGED (HOLES).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504480 ↗
• MalfunctionAug 11, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A 7-8 CM MALIGNANT STENOSIS IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT COVER WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390280 ↗
• InjuryJun 29, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 05, 2020 THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT EXPERIENCED DISCOMFORT AND INCREASED BILIRUBIN WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT PLACEMENT. ON (B)(6), 2020, IMAGING WAS PERFORMED AND CONFIRMED THAT THE STENT MIGRATED. THE STENT NATURALLY PASSED OUT OF THE PATIENT. REPORTEDLY, THE STRICTURE HAD NOT YET RESOLVED WHEN THE STENT MIGRATED. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S BILIRUBIN WAS TOO HIGH TO ACCEPT A SECOND PROCEDURE AT THIS TIME AND THE PATIENT WILL BE RE-SCHEDULED FOR A SECOND PROCEDURE FOR STENT IMPLANTATION. THE PATIENT RECEIVED DRUG THERAPY TREATMENT FOR THE DISCOMFORT AND INCREASED BILIRUBIN. IN THE PHYSICIAN'S ASSESSMENT, THE STENT MIGRATION MAY HAVE CAUSED THE DISCOMFORT AND THE STENT MIGRATION CAUSED THE INCREASED BILIRUBIN. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Discomfort; Liver Damage/Dysfunction

  MAUDE report 10206733 ↗
• MalfunctionMay 21, 2020Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COVERED WALLFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A 3 CENTIMETER SIZED CANCER IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER COVERED WALLFLEX BILIARY 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT COVER DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10079189 ↗
• InjuryMar 12, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED IN THE IN THE COMMON BILE DUCT TO TREAT MALIGNANT STENOSIS DURING A STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT MOVED OUT OF THE INTENDED LOCATION. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9825490 ↗
• MalfunctionMar 11, 2020Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A STENOSIS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AFTER ADVANCING THROUGH THE LESION. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHAFT/ SHEATH WAS DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9819962 ↗
• InjuryMay 13, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED INSIDE THE PATIENT. HOWEVER, IT WAS NOTICED THAT THERE WAS A HOLE ON THE COVER OF THE STENT'S TIP. THE STENT WAS REMOVED WITH SNARES AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605363 ↗
• MalfunctionApr 26, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, IT WAS NOTICED THAT THE STENT COVER WAS BROKEN AT THE FRONT TIP. THE DEPLOYED STENT WAS REMOVED WITH A SNARE AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8556884 ↗
• InjuryOct 31, 2018Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE HEPATIC PORTAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT PRESENTED WITH HIGH BILIRUBIN LEVEL WHICH PROMPTED THE PHYSICIAN TO CHECK THE STENT PLACEMENT. AN ERCP WAS PERFORMED AND FOUND THAT THE STENT WAS DISPLACED. ON (B)(6) 2018, THE STENT WAS REMOVED WITH SNARE AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. REPORTEDLY, THE STRICTURE HAD RESOLVED WHEN THE STENT MIGRATED.

  Patient problems: Jaundice

  MAUDE report 8026132 ↗
• InjuryOct 15, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY THE PATIENT'S ANATOMY WAS TIGHT. ACCORDING TO THE COMPLAINANT, AT THE END OF THE STENT PLACEMENT PROCEDURE, ANGIOGRAPHY WAS PERFORMED AND NOTICED THAT THE STENT MOVED OUT FROM THE ORIGINAL LOCATION. THE STENT WAS REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965770 ↗
• InjurySep 27, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 3, 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT' ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A HOLE WAS NOTED ON THE STENT COVER AFTER THE STENT WAS DEPLOYED INSIDE THE PATIENT. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914151 ↗
• InjuryJul 30, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STENOSIS IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, UNDER RADIOGRAPHY THE STENT WAS NOTED TO MOVE OUT OF POSITION. THE STENT WAS REMOVED WITH FORCEPS AND ANOTHER WALLFLEX BILIARY STENT WAS PLACED TO 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7732008 ↗
• InjuryJun 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED TO TREAT A SEVERE STENOSIS IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, ON (B)(6) 2018, A ROUTINE RADIOGRAPHIC (X-RAY) PROCEDURE WAS PERFORMED TO CHECK THE LOCATION AND PATENCY OF THE STENT. THE IMAGE SHOWED THE STENT HAD MIGRATED. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589277 ↗
• InjuryMay 8, 2018Difficult to Remove; Difficult to Remove

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PATIENT AND PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2018-01508 AND 3005099803-2018-01503 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO WALLFLEX BILIARY RX FULLY COVERED RMV STENTS WERE TO BE USED IN THE DISTAL COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST STENT, A 10 X 80 MM WALLFLEX BILIARY RX FULLY COVERED RMV STENT (THE SUBJECT OF THIS REPORT) WAS ABLE TO BE DEPLOYED. HOWEVER, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE THROUGH THE STENT OR FROM THE PATIENT UPON WITHDRAWAL. AN ATTEMPT TO RE-CONSTRAIN THE DELIVERY SYSTEM WAS MADE BUT IT WAS UNSUCCESSFUL. THE PHYSICIAN CUT THE DELIVERY SYSTEM AT THE PATIENT¿S MOUTH AND REMOVED THE DUODENOSCOPE. TWO DILATATION BALLOON CATHETERS WERE USED TO SLIGHTLY DILATE THE STENT AND THEN DELIVERY SYSTEM REMOVAL WAS ATTEMPTED AGAIN; HOWEVER, IT WAS UNSUCCESSFUL. THE STENT AND DELIVERY SYSTEM WERE THEN REMOVED WITH A RAT TOOTH FORCEPS. A SE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496649 ↗
• MalfunctionFeb 21, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX COVERED STENT WAS TO BE USED TO TREAT MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TOO TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLUE OUTER SHEATH WAS SEPARATED FROM THE GUIDEWIRE ACCESS PORT AND THE STENT WOULD NOT DEPLOY. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7286384 ↗
• InjuryJan 10, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX BILIARY RX COVERED STENT WAS IMPLANTED TO TREAT A STENOSIS IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING AN IMAGING RECHECK OF THE STENT ON (B)(6) 2017, THE STENT WAS FOUND TO HAVE SLIGHTLY MIGRATED. ON THE SAME DATE, THE MIGRATED STENT WAS REMOVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178355 ↗