WALLSTENT™ RX BILIARY M00569710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729296911), received between Nov 12, 2019 and Jan 27, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗