WallFlex Biliary M00570370Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 08714729953180), received between May 25, 2017 and Sep 21, 2026 — classified as 3 deaths, 93 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (57 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 7, 2020Terminated

   Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

   Z-2958-2020 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Premature Activation

  It was reported to Boston Scientific Corporation that a WallFlex Biliary Stent was attempted to be implanted during an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure for biliary obstruction performed on (b)(6) 2026.During the procedure, at the end of the case, the physician requested a 10 x 60 mm fully covered WallFlex stent. The device packaging was undamaged; however, upon opening the package, the stent was found to be already deployed within the sealed package. A new stent was opened and successfully deployed. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838813 ↗
• InjuryJun 25, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX FULLY COVERED BILIARY STENT WAS IMPLANTED TO TREAT A PANCREATIC HEAD MASS WITH STRICTURE IN THE DISTAL COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WALLFLEX STENT WAS SUCCESSFULLY PLACED WITH NO COMPLICATIONS. HOWEVER, A FEW DAYS POST-STENT PLACEMENT, DURING AN EMERGENT FOLLOW-UP, IT WAS NOTED THAT THE PATIENT'S LIVER FUNCTION TEST RESULTS HAD SUDDENLY INCREASED, AND THE PATIENT COMPLAINED OF PAIN. IMAGING WAS PERFORMED, AND NO METAL STENT WAS LOCATED. IN THE PHYSICIAN'S ASSESSMENT, THE STENT HAD MIGRATED DISTALLY. THE PATIENT THEN UNDERWENT A REPEAT ERCP, AND A NEW BILIARY METAL STENT WAS PLACED.

  Patient problems: Foreign Body In Patient; Liver Damage/Dysfunction; Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 25627515 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2026, DURING A ROUTINE FOLLOW-UP AFTER STENT PLACEMENT, IT WAS FOUND THAT THE STENT HAD MIGRATED AND GOT STUCK IN THE SMALL BOWEL, CAUSING A PERFORATION. SURGERY WAS PERFORMED, AND THE STENT WAS EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS

  Patient problems: Bowel Perforation

  MAUDE report 24735941 ↗
• DeathDec 11, 2025Difficult to Remove; Material Deformation; Device Stenosis; Difficult to Remove; Material Deformation; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2025, THE PATIENT PRESENTED FOR STENT REMOVAL. DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN TRIED TO PULL THE STENT OUT. HOWEVER, THERE WAS TISSUE INGROWTH THROUGH THE DISTAL WIRES OF THE STENT. THE STENT WOULD NOT MOVE, AND TISSUE DAMAGE WOULD OCCUR IF THE STENT WAS FORCIBLY REMOVED. THE PHYSICIAN DECIDED TO PLACE ANOTHER STENT THROUGH THE DAMAGED STENT (STENT-ON-STENT FASHION), WHICH SUCCESSFULLY COMPLETED THE PROCEDURE. FOLLOWING THE SUCCESSFUL PLACEMENT, THE PATIENT PASSED AWAY. IT WAS NOTED THAT THE PATIENT DEATH WAS NOT RELATED TO THE PRODUCT MALFUNCTION BUT FROM PULMONARY EMBOLISM.

  Patient problems: Pulmonary Embolism

  MAUDE report 23783889 ↗
• MalfunctionNov 13, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED INTO THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AFTER THE STENT WAS DEPLOYED, THE DELIVERY SYSTEM WAS EXTREMELY DIFFICULT TO REMOVE. THE CATHETER WAS DESHEATHED. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547551 ↗
• InjuryOct 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. REPORTEDLY, THE STRICTURE WAS SO TIGHT THAT THE WALLFLEX STENT WAS NO ABLE TO FULLY OPEN ONCE DEPLOYED. THE STENT WAS REMOVED USING RAT TOOTH FORCEPS, AND A SHORTER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306394 ↗
• MalfunctionSep 5, 2025Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE DURING PREPARATION, THE STENT WAS PREMATURELY DEPLOYED IN THE CATHETER ONCE REMOVED FROM THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22979111 ↗
• InjuryMay 1, 2025Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN BELIEVES THAT THE METAL STENT IS LONGER THAN THE LABELED LENGTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946010 ↗
• InjuryApr 17, 2025Defective Device; Defective Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2025-01721 AND 3005099803-2025-01723 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY RX FULLY COVERED RMV STENTS WERE TO BE IMPLANTED IN THE BILE DUCT FOR THE TREATMENT OF PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE STENT WAS IN THE INTRAHEPATIC DUCTS, BUT A LARGE PORTION OF THE STENT WAS STILL IN THE DUODENUM. THE PHYSICIAN STATED THAT THE STENT WAS 'ACTING LIKE A 10X80' STENT; HOWEVER, THE STENT WAS NOT MEASURED DURING THE PROCEDURE. A SECOND WALLFLEX BILIARY STENT OF THE SAME SIZE WAS USED, BUT THE SAME ISSUE RECURRED. IT IS UNKNOWN HOW THE STENTS WERE REMOVED FROM THE PATIENT, AND A DIFFERENT SIZE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862377 ↗
• InjuryApr 17, 2025Defective Device; Defective Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2025-01721 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY RX FULLY COVERED RMV STENTS WERE TO BE IMPLANTED IN THE BILE DUCT FOR THE TREATMENT OF PANCREATIC CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON MARCH 26, 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS OBSERVED UNDER FLUOROSCOPY THAT THE STENT WAS IN THE INTRAHEPATIC DUCTS, BUT A LARGE PORTION OF THE STENT WAS STILL IN THE DUODENUM. THE PHYSICIAN STATED THAT THE STENT WAS 'ACTING LIKE A 10X80' STENT; HOWEVER, THE STENT WAS NOT MEASURED DURING THE PROCEDURE. A SECOND WALLFLEX BILIARY STENT OF THE SAME SIZE WAS USED, BUT THE SAME ISSUE RECURRED. IT IS UNKNOWN HOW THE STENTS WERE REMOVED FROM THE PATIENT, AND A DIFFERENT SIZE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862372 ↗
• InjuryMar 31, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY STENTS WERE TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST STENT (SUBJECT OF REPORT 3005099803-2025-01280) WAS SUCCESSFULLY DEPLOYED, HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEPLOYMENT CATHETER, THE STENT DISLODGED. THE PHYSICIAN THEN REMOVED THE FIRST STENT AND ATTEMPTED TO IMPLANT A SECOND WALLFLEX STENT (SUBJECT OF THIS REPORT) BUT THE ISSUE OCCURRED AGAIN, THE STENT DISLODGED. BOTH STENTS WERE REMOVED USING GRASPING FORCEPS. THE PHYSICIAN DECIDED THEN TO USE A PLASTIC STENT AS REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BILE DUCT WAS NARROW WITH MALIGNANT STENOSIS OF 6 TO 7CM IN SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731057 ↗
• InjuryMar 31, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY STENTS WERE TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE CAUSED BY CANCER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST STENT (SUBJECT OF THIS REPORT) WAS SUCCESSFULLY DEPLOYED, HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEPLOYMENT CATHETER, THE STENT DISLODGED. THE PHYSICIAN THEN REMOVED THE FIRST STENT AND ATTEMPTED TO IMPLANT A SECOND WALLFLEX STENT (SUBJECT OF REPORT 3005099803-2025-01294) BUT THE ISSUE OCCURRED AGAIN, THE STENT DISLODGED. BOTH STENTS WERE REMOVED USING GRASPING FORCEPS. THE PHYSICIAN DECIDED THEN TO USE A PLASTIC STENT AS REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BILE DUCT WAS NARROW WITH MALIGNANT STENOSIS OF 6 TO 7CM IN SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731053 ↗
• MalfunctionMar 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. DURING PROCEDURE, POST DEPLOYMENT THE STENT'S RETRIEVAL LOOP WAS DEFORMED. THE PATIENT IS SCHEDULED FOR A FOLLOW UP SPYGLASS PROCEDURE IN A FEW WEEKS. THE PHYSICIAN IS COMFORTABLE LEAVING THE STENT INSIDE THE PATIENT AND IS PLANNING TO SWAP THE STENT FOR A NEW ONE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21702135 ↗
• MalfunctionMar 17, 2025Activation, 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 WAS IMPLANTED TO TREAT BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PREPARATION, WHEN THE STAFF OPENED THE PACKAGE, THE TIP WAS BENT, AND THE STENT WAS PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WITH ANOTHER SAME OF DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21625507 ↗
• InjuryJan 2, 2025Break; Difficult to Remove; Human-Device Interface Problem; Material Deformation; Device Stenosis; Break; Difficult to Remove; Human-Device Interface Problem; Material Deformation; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2024, DURING A STENT REMOVAL PROCEDURE, THE STENT WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE STENT WAS FRAYED AND BROKEN IN HALF, AND TISSUE OVERGROWTH WAS ALSO NOTED, WHICH RESULTED IN DIFFICULTY IN REMOVING THE STENT. THE STENT REMAINS IMPLANTED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21064063 ↗
• InjuryNov 27, 2024Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation; Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS VERY DIFFICULT TO DEPLOY BUT WAS EVENTUALLY DEPLOYED WHEN THE HANDLE WAS FULLY RETRACTED. DURING REMOVAL OF THE CATHETER, IT WAS NOTED THAT THE INNER CATHETER BROKE. THE DETACHED CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801247 ↗
• InjuryOct 25, 2024Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO RESHEATH THE CATHETER BEFORE REMOVING IT FROM THE SCOPE, BUT THE CATHETER BECAME STUCK IN THE SCOPE. THE PHYSICIAN ULTIMATELY HAD TO YANK ON THE CATHETER, WHICH CAUSED THE INNER SHEATH TO BREAK INSIDE THE PATIENT'S STOMACH. A RESCUE FORCEPS WAS USED TO REMOVE THE BROKEN PIECE. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20538112 ↗
• InjuryOct 14, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE ON (B)(6) 2024, DURING A STENT REMOVAL PROCEDURE PERFORMED AROUND 6 MONTHS LATER FROM THE INITIAL IMPLANT, THE STENT WAS ATTEMPTED TO BE REMOVED USING A SNARE BY PULLING THE STENT OUT OF THE DUCT; HOWEVER, AFTER SEVERAL ATTEMPTS, THE STENT WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN REINSERTED THE DUODENOSCOPE INTO THE DUODENUM AND IT WAS FOUND THAT THE STENT BROKE IN THE MIDDLE. THE SNARE WAS REMOVED, AND A RAT TOOTH FORCEPS WAS USED TO REMOVE THE STENT BY GRABBING THE PROXIMAL SECTIONS OF STENT ABOVE THE MIDDLE WHERE IT WAS FRACTURED. THE STENT WAS EVENTUALLY ABLE TO BE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440847 ↗
• InjuryOct 3, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS TO BE USED IN THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING UNPACKING, THE PACKAGING WAS NOTED TO BE DAMAGED. THE STENT WAS ALSO BENT AND DAMAGED. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359886 ↗
• InjurySep 23, 2024Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. ON (B)(6) 2024, THREE MONTHS POST-STENT PLACEMENT PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE STENT; HOWEVER, IT BROKE IN HALF. THE PHYSICIAN ATTEMPTED TO SWEEP THE STENT OUT USING MULTIPLE DEVICES BUT WAS UNSUCCESSFUL. THE PHYSICIAN LATER USED A SPYGLASS TO GRAB THE STENT AND SUCCESSFULLY REMOVED IT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND THE STENT WAS NOTED TO BE DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20285767 ↗
• InjuryAug 22, 2024Difficult to Remove; Device Stenosis; Difficult to Remove; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BENIGN STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED SIX MONTHS PRIOR. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. POST STENT PLACEMENT, ON AN UNKNOWN DATE, THE STENT WAS ATTEMPTED TO BE REMOVED USING SNARE, RAT-TOOTH FORCEPS, AND EXTRACTION BALLOON; HOWEVER, THE STENT WAS UNABLE TO BE REMOVED DUE TO TISSUE INGROWTH ON THE RETRIEVAL LOOP. CONSEQUENTLY, A 10X80 WALLFLEX BILIARY STENT WAS PLACED INSIDE THE ORIGINAL STENT TO ALLOW PRESSURE NECROSIS AND LOOSEN THE TISSUE INGROWTH. ON JULY 29, 2024, THE PATIENT RETURNED FOR ANOTHER STENT REMOVAL PROCEDURE. THE STENT WAS ATTEMPTED TO BE REMOVED USING SNARE AND RAT-TOOTH FORCEPS, BUT THE STENT WAS STILL UNABLE TO BE REMOVED. SUBSEQUENTLY, ARGON PLASMA COAGULATION (APC) WAS DONE TO REMOVE THE TISSUE. EVENTUALLY, THE STENT WAS ABLE TO BE REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031833 ↗
• InjuryAug 20, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENTS WAS USED IN THE COMMON BILE DUCT TO TREAT COMMON BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS INITIALLY MISDEPLOYED DURING THE PROCEDURE, BUT IT WAS SUCCESSFULLY COMPLETED USING ANOTHER STENT OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000435 ↗
• MalfunctionJul 24, 2024Difficult to Remove; Material Integrity Problem; Positioning Problem; Difficult to Remove; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE BILIARY TREE TO TREAT A 3CM TUMOR DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, WHEN THE PHYSICIAN PULLED OUT THE DELIVERY SYSTEM, THE STENT STARTED TO DISLODGE. SUBSEQUENTLY, THE NURSE TRIED TO RESHEATH THE CATHETER WHILE PULLING ON THE DELIVERY SYSTEM; HOWEVER, THE STENT MOVED OUT OF ITS LOCATION. THE PHYSICIAN THEN PULLED THE DELIVERY SYSTEM AND IT WAS EVENTUALLY REMOVED. THE STENT WAS IMPLANTED BUT IT WAS HANGING MORE IN THE DUODENUM THAN WHAT WAS PLANNED, AND THE CATHETER WAS NOTED TO HAVE BEEN DAMAGED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822691 ↗
• InjuryJun 28, 2024Break; Material Deformation; Migration; Break; Material Deformation; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT BILIARY STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ON (B)(6) 2024, THE STENT WAS SCHEDULED TO BE REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT HAD MIGRATED PROXIMALLY INTO THE COMMON BILE DUCT AND WAS ATTEMPTED TO BE RETRIEVED USING A RAT-TOOTH GRASPER. THE PHYSICIAN THEN DILATED THE PAPILLA AND PULLED THE STENT DOWN WITH A BALLOON AND RAT-TOOTH GRASPER. HOWEVER, THE STENT BROKE DURING THIS TIME AND BEGAN TO UNRAVEL COMPLETELY. THE STENT WAS EVENTUALLY REMOVED BUT THE PROCEDURE WAS EXTENDED FOR 2 HOURS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19631198 ↗
• MalfunctionMay 22, 2024Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem; Device Markings/Labelling Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED RMV STENT WAS IMPLANTED TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE DISTAL PORTION OF THE FULLY COVERED STENT APPEARED UNCOVERED. THE STENT REMAINED IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MAY 23, 2024: THE COMPLAINT ABOUT THE DISTAL PORTION OF THE WALLFLEX BILIARY FULLY COVERED STENT APPEARING UNCOVERED WAS RESCINDED BECAUSE THE DEVICE RESEMBLED THE PHOTO OF A WALLFLEX BILIARY FULLY COVERED STENT DISPLAYED ON BOSTON SCIENTIFIC'S OFFICIAL WEBSITE. WHEREIN IT SHOWED THAT THE WALLFLEX BILIARY FULLY COVERED IS NOT "FULLY COVERED" ON BOTH ENDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372945 ↗