WALLSTENT RX BILIARYRecalls & reported problems across all models

We found 7 models of WALLSTENT RX BILIARY by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2017 and Dec 10, 2024 — classified as 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported WALLSTENT RX BILIARY problems

WALLSTENT RX BILIARY models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• WALLSTENT™ RX BILIARY M00569810

  CATHETER, BILIARY, DIAGNOSTIC
  7 reports
• WALLSTENT™ RX BILIARY M00569660

  CATHETER, BILIARY, DIAGNOSTIC
  6 reports
• WALLSTENT™ RX BILIARY M00569650

  CATHETER, BILIARY, DIAGNOSTIC
  4 reports
• WALLSTENT™ RX BILIARY M00569710

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• WALLSTENT™ RX BILIARY M00569720

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• WALLSTENT™ RX BILIARY M00569620

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• WALLSTENT™ RX BILIARY M00569690

  CATHETER, BILIARY, DIAGNOSTIC
  1 report

Recent WALLSTENT RX BILIARY adverse event reports

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

• MalfunctionDec 10, 2024Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT RX BILIARY UNCOVERED STENT WAS USED TO TREAT AN APPROXIMATELY 6CM MALIGNANT HILAR STRICTURE DUE TO CHOLANGIO CARCINOMA DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON NOVEMBER 13, 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT WIRE OF THE STENT WAS COMING OUT OF THE SHEATH, WHICH RESULTED IN DEPLOYMENT FAILURE. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898990 ↗
• InjuryApr 22, 2024Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY UNCOVERED STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILIARY STRICTURE DURING A 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, RESISTANCE WAS FELT DURING DELIVERY AND THE PATIENT EXPERIENCED PAIN. THE DEVICE WAS THEN REMOVED, AND IT WAS NOTED THAT THE STENT WIRE PUNCTURED THE TIP PART OF THE OUTER SHEATH CAUSING INJURY TO THE PATIENT'S BILIARY VESSEL. THE PATIENT WAS ADMINISTERED WITH PAINKILLERS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A BENIGN STENOSIS. HOWEVER, PER THE WALLSTENT RX BILIARY, WITH OR WITHOUT PERMALUME COVERING INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE IN THE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS. THE DEVICE IS NOT INDICATED FOR THE TREATMENT OF BENIGN STENOSIS. PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED SHOWING THE STENT'S WIRE PUNCTURED THE OUT

  Patient problems: Insufficient Information; Pain

  MAUDE report 19153620 ↗
• MalfunctionAug 8, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) 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 WALLSTENT BILIARY STENT COULD NOT BE FULLY DEPLOYED. THE WALLSTENT BILIARY STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT WIRES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188677 ↗
• MalfunctionMar 3, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 11, 2022 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 10MM MALIGNANT OBSTRUCTION IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM THROUGH THE STENOSIS. THE STENOSIS WAS DILATED AND ANOTHER ATTEMPT TO CROSS THE STENOSIS WAS MADE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO DEVICE AVAILABILITY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13660182 ↗
• InjuryJan 7, 2022Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 15, 2021 THAT A WALLSTENT BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE UPPER COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT DEPLOYED PREMATURELY. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 13191663 ↗
• MalfunctionSep 21, 2021Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT OBSTRUCTIVE JAUNDICE, SECONDARY MALIGNANT TUMORS OF THE PANCREAS AND LIVER AND POSTOPERATIVE COLON CANCER IN THE BILIARY TRACT DURING A TRANSDUODENAL ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRES PROTRUDED FROM THE OUTER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505878 ↗
• MalfunctionJul 19, 2021Break; Material Deformation; Activation Failure; Break; Material Deformation; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS IMPLANTED TO TREAT A 7-CM MALIGNANT STRICTURE IN THE LOWER COMMON BILE DUCT (CBD) DURING BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY UNDER FLUOROSCOPY. HOWEVER, THE PHYSICIAN NOTED THAT THE DISTAL END OF THE STENT DID NOT FULLY EXPAND. ADDITIONALLY, IT WAS NOTED THAT THE STENT WIRES WERE KINKED AND BROKEN AT THE PROXIMAL END OF THE STENT. THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED. 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. HOWEVER, THE PHYSICIAN WILL CONTINUE TO FOLLOW UP TO CONFIRM THERE ARE NOT ANY ISSUES DUE TO THE DAMAGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188654 ↗
• MalfunctionJul 13, 2021Entrapment of Device; Mechanical Problem; Premature Activation; Material Deformation; Entrapment of Device; Mechanical Problem; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT BILE DUCT CANCER DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS PARTIALLY DEPLOYED WITHIN THE RECONSTRAINABILITY LIMIT. THE PHYSICIAN ATTEMPTED TO READJUST THE STENT BUT IT WAS UNABLE TO RECONSTRAIN. THE DEVICE WAS REMOVED AND ANOTHER WALLSTENT BILIARY STENT WAS IMPLANTED 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THE STENT WAS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON JULY 1, 2021 AND JULY 12, 2021: WHILE REMOVING THE STENT, IT GOT STUCK WITHIN THE WORKING CHANNEL OF THE SCOPE AND HENCE GOT KINKED, DAMAGED AND DEPLOYED DURING THE RETRIEVAL PROCESS. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158424 ↗
• MalfunctionJun 21, 2021Failure to Advance; Appropriate Device Problem Term/Code Not Available; Failure to Advance; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A 1.5CM MALIGNANT OBSTRUCTION IN THE MIDDLE AND UPPER COMMON BILE DUCT 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. DURING THE PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION. THE STENT WAS FULLY COVERED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PATIENT FELT DISCOMFORT AND THE PROCEDURE WAS CANCELLED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Discomfort

  MAUDE report 12033736 ↗
• MalfunctionFeb 9, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A HILAR CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO FULLY DEPLOY INSIDE THE PATIENT. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO RE-CONSTRAIN THE STENT. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND ANOTHER WALLSTENT BILIARY STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PHYSICIAN FULLY DEPLOYED THE STENT OUTSIDE OF THE PATIENT. 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 WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300432 ↗
• MalfunctionJan 27, 2021Positioning Failure; Material Puncture/Hole; Positioning Failure; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON THAT A WALLSTENT BILIARY RX PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 4CM CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. 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 DEPLOY PARTIALLY AND WAS RECAPTURED TO CHANGE POSITION. WHEN THE STENT WAS DEPLOYED AGAIN, RESISTANCE OCCURED AND THE STENT FAILED TO DEPLOY. REPORTEDLY, THE STENT WAS FULLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 WIRE PUNCTURED THE CLEAR OUTER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11236190 ↗
• InjuryJun 18, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT OBSTRUCTION IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILIARY DUCT METAL IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED. DURING REMOVAL OF THE DELIVERY SYSTEM, THE CATHETER GOT STUCK AND COULD NOT BE RETRIEVED. THE PHYSICIAN SHOOK THE DELIVERY SYSTEM AND WAS ABLE TO REMOVE THE CATHETER FROM THE PATIENT. HOWEVER, IT WAS NOTICED THATHE STENT WAS DISPLACED OUTWARD. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX BILIARY. 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 10171195 ↗
• MalfunctionMay 28, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 08, 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A TUMOR IN THE PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED INSIDE THE PATIENT. THE DEVICE WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT OUTSIDE THE PATIENT. REPORTEDLY, THE CLEAR OUTER SHEATH OPENED A LITTLE BIT BUT THE STENT COULD NOT BE RELEASED FURTHER. PER REVIEW OF THE VIDEO AND PHOTO PROVIDED BY THE COMPLAINANT, THE STENT WIRES WERE BENT. 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. DESPITE EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098794 ↗
• InjuryApr 9, 2020Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A WALLSTENT BILIARY RX UNCOVERED STENT WAS TO BE USED TO TREAT A 1.5 CM MALIGNANT STRICTURE IN THE LOWER COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, DURING CATHETER REMOVAL, THE DELIVERY SYSTEM GOT STUCKED ON THE STENT. THE PHYSICIAN EXERTED FORCE TO REMOVE THE DELIVERY SYSTEM AND THE STENT WAS DISPLACED. THE STENT WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT 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 9945818 ↗
• InjuryNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLSTENT BILIARY RX PARTIALLY COVERED STENT HAD BEEN IMPLANTED TO TREAT PANCREATIC CANCER DURING A PROCEDURE PERFORMED IN 2005. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE TIP OF THE STENT WAS LEFT INSIDE THE PATIENT BUT MAJORITY OF THE STENT WAS REMOVED. SINCE THEN, THE PATIENT HAD SUCCESSFULLY HAD AN MRI OF THE KNEE AND BREAST. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9311746 ↗

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