WallFlex™ Biliary M00570740Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729759331), received between Jan 27, 2017 and Jul 20, 2026 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Activation Failure

  It was reported to Boston Scientific Corporation that a WallFlex Biliary Stent was to be implanted to treat a common bile duct (CBD) stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ERCP) with metal stenting procedure performed on (b)(6) 2026. During stent deployment, the physician and nursing staff observed that the stent failed to fully expand despite waiting approximately three minutes. Consequently, the physician elected to remove the stent using forceps. Another WallFlex Biliary Stent was used to complete the procedure. There were no patient complications as a result of this event and the patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883946 ↗
• InjuryNov 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED INTO THE COMMON BILE DUCT TO TREAT A STRICTURE CAUSED BY 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 PROCEDURE, THE SHEATH HAD ALREADY FULLY RETRACTED, AND THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, THE STENT REMAINED CONSTRAINED, IT FAILED TO EXPAND. THE PHYSICIAN AND NURSES WAITED FOR TWO TO THREE MINUTES BUT THE STENT REMAINED CONSTRAINED. THE STENT WAS THEN REMOVED WITH THE USE OF FORCEPS, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER WALLFLEX BILIARY STENT OF A DIFFERENT LENGTH. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648626 ↗
• InjuryMay 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE RETURNED BEFORE THE MARKER REACHED THE NON-RETURN POINT. THE DOCTOR DEPLOYED THE STENT AND THEN REMOVED IT FROM THE PATIENT. ANOTHER STENT OF DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON MAY 20, 2024. IT WAS REPORTED THAT THE SIZE OF THE LESION WAS 6MM AND LESION WAS MALIGNANT. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366981 ↗
• MalfunctionAug 7, 2023Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Break; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE HANDLE BROKE, THE INNER SHEATH SNAPPED INSIDE THE CATHETER, AND THE STENT COULD NOT BE FULLY DEPLOYED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17474747 ↗
• InjuryMay 31, 2023Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 10, 2023, THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE SPHINCTER OF ODDI TO TREAT A MALIGNANT STENOSIS DUE TO A TUMOR DURING A PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE WALLFLEX BILIARY STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, RESISTANCE WAS FELT DURING REMOVAL OF THE DELIVERY SYSTEM. THE PHYSICIAN APPLIED FORCE TO REMOVE THE DELIVERY SYSTEM AND A PART OF THE YELLOW INNER SHEATH WAS DETACHED, AND THE IMPLANTED WALLFLEX BILIARY PARTIALLY COVERED STENT MOVED OUT OF THE CORRECT POSITION. THE DETACHED INNER SHEATH AND THE STENT WERE REMOVED FROM THE PATIENT USING FORCEPS, AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED BY THE COMPLAINANT AND SHOWED THE YELLOW INNER SHEATH WAS DETACHED AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17032965 ↗
• MalfunctionJul 25, 2022Entrapment of Device; Entrapment of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE WALLFLEX BILIARY STENT. REFER TO MANUFACTURER REPORT # 3005099803-2022-03912 AND 3005099803-2022-03915 FOR THE ASSOCIATED PROCEDURE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 05, 2022 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANCY COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE FIRST PROCEDURE (THE SUBJECT OF MFR. REPORT #3005099803-2022-03912), FRICTION WAS MET INSIDE THE SCOPE AND WHEN THE WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE USED IT WAS NOTED THAT THERE WAS NO STENT ON THE DELIVERY SYSTEM. THE DELIVERY SYSTEM OF THE WALLFLEX BILIARY STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT WITHOUT ISSUE. HOWEVER, AFTER THE SCOPE WAS CLEANED AND ATTEMPTED TO BE USED IN A SECOND PROCEDURE (THE SUBJECT OF THIS REPORT), FRICTION WAS NOTED WHILE ADVANCING AN UNKNOWN CATHETER DEVICE THROUGH THE WORKING CHANNEL OF THE SCOPE. A METAL WIRE OF A STENT WAS THEN NOTED AT THE TIP OF THE SCOPE. IT WAS DETERMINED THAT THE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094527 ↗
• MalfunctionJul 25, 2022Entrapment of Device; Premature Activation; Difficult to Advance; Entrapment of Device; Premature Activation; Difficult to Advance

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE WALLFLEX BILIARY STENT. REFER TO MANUFACTURER REPORT # 3005099803-2022-03915 FOR THE ASSOCIATED PROCEDURE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 05, 2022 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANCY COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE FIRST PROCEDURE (THE SUBJECT OF THIS REPORT), FRICTION WAS MET INSIDE THE SCOPE AND WHEN THE WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE USED IT WAS NOTED THAT THERE WAS NO STENT ON THE DELIVERY SYSTEM. THE DELIVERY SYSTEM OF THE WALLFLEX BILIARY STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT WITHOUT ISSUE. HOWEVER, AFTER THE SCOPE WAS CLEANED AND ATTEMPTED TO BE USED IN A SECOND PROCEDURE (THE SUBJECT OF MFR. REPORT #3005099803-2022-03915), FRICTION WAS NOTED WHILE ADVANCING AN UNKNOWN CATHETER DEVICE THROUGH THE WORKING CHANNEL OF THE SCOPE. A METAL WIRE OF A STENT WAS THEN NOTED AT THE TIP OF THE SCOPE. IT WAS DETERMINED THAT THE WALLFLEX BILIARY STENT NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094514 ↗
• InjuryApr 19, 2022Difficult to Remove; Failure to Advance; Material Integrity Problem; Difficult to Remove; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM THROUGH THE LESION. THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THERE WAS DIFFICULTY ENCOUNTERED DURING WITHDRAWAL OF THE DELIVERY SYSTEM THROUGH THE DEPLOYED STENT. THE PERMALUME COVER OF THE STENT WAS TORN DURING THE DELIVERY SYSTEM REMOVAL. REPORTEDLY, THE STENT WAS TOO LONG FOR THE PATIENT'S ANATOMY AND THE PHYSICIAN CHOSE TO REMOVE AND REPLACE IT. THE STENT WAS DIFFICULT TO REMOVE BUT WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A SMALLER SIZED WALLFLEX BILIARY PARTIALLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14147940 ↗
• MalfunctionDec 17, 2021Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 4-5 CM CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN DID NOT KNOW HOW TO DEPLOY THE STENT CORRECTLY AND THE STENT WAS DEPLOYED IN AN INCORRECT LOCATION. THE STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX BILIARY STENT WAS IMPLANTED 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. NOTE: IT WAS REPORTED THAT THE PHYSICIAN DID NOT KNOW HOW TO DEPLOY THE STENT CORRECTLY. PER THE DFU, "THE WALLFLEX BILIARY RX PARTIALLY COVERED STENT SYSTEM SHOULD ONLY BE USED BY OR UNDER THE SUPERVISION OF PHYSICIANS THOROUGHLY TRAINED IN BILIARY PROSTHESIS PLACEMENT. A THOROUGH UNDERSTANDING OF THE TECHNICAL PRINCIPLES, CLINICAL APPLICATIONS, AND RISKS ASSOCIATED WITH THIS PROCEDURE IS NECESSARY BEFORE USING THIS DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026652 ↗
• MalfunctionJan 7, 2021Break; Positioning Failure; Material Integrity Problem; Break; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AND THE OUTER SHEATH BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. NOTE: THIS EVENT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT COVER WAS DAMAGED (HOLES).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11130603 ↗
• InjuryMay 13, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS USED TO BE USED TO TREAT A 4CM MALIGNANT STRICTURE IN THE MID COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING STENT CATHETER REMOVAL, THE DELIVERY SYSTEM GOT CAUGHT ON THE STENT WHICH ALSO PULLED THE STENT FROM THE TARGET STRICTURE. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS 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 8605332 ↗
• InjuryMar 15, 2018Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT AN OBSTRUCTION IN THE COMMON BILE DUCT DUE TO A MASS IN THE HEAD OF THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. 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 WAS ABLE TO BE DEPLOYED. HOWEVER, DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE DISTAL TIP OF THE CATHETER WAS CAUGHT ON THE STENT AND COULD NOT BE REMOVED WITHOUT PULLING THE STENT OUT FROM THE PATIENT. THE PHYSICIAN REMOVED THE STENT AND DELIVERY SYSTEM WITH FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY RX 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 7341698 ↗
• InjuryFeb 8, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT, HOWEVER, IT WAS FOUND THAT THE POLYMER COATING WAS MISSING AT THE MIDDLE PART OF THE STENT. THE PHYSICIAN REMOVED THE FULLY DEPLOYED STENT 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7253763 ↗
• MalfunctionFeb 8, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX PARTIALLY COVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE ANATOMY OF THE PATIENT WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INSERTED THE WALLFLEX BILIARY RX PARTIALLY COVERED STENT OVER THE WIRE AND THE DEPLOYMENT MECHANISM WOULD NOT RELEASE. THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH A DIFFERENT SIZE 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 FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; THE OUTER SHEATH WAS DETACHED/BROKEN AT THE OUTER DIAMETER: PROXIMAL EXTERIOR TUBE ¿ ENDOSCOPE INTERFACE (NEAR THE GUIDEWIRE ACCESS SHEATH).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7253295 ↗
• MalfunctionJan 27, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX BILIARY PARTIALLY COVERED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, PATIENT¿S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT WHEN THE INNER CATHETER CAME OUT OF THE GUIDEWIRE ACCESS PORT AND THE OUTER SHEATH BROKE AT THE GUIDEWIRE ACCESS PORT. THE STENT FAILED TO DEPLOY 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6283432 ↗