WALLSTENT™ BILIARY H965431000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729317920), received between Feb 27, 2020 and Jun 9, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionJun 9, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLSTENT BILIARY PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT A 4-5 CM MALIGNANT STENOSIS IN THE COMMON BILE DUCT DURING A BILIARY STRICTURE DILATION PROCEDURE PERFORMED ON APRIL 19, 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED INSIDE THE PATIENT. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND ANOTHER WALLSTENT BILIARY DEVICE 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 A MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WIRES WERE LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11965878 ↗
• MalfunctionFeb 27, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 3, 2020 THAT A WALLSTENT BILIARY STENT HAS BEEN IMPLANTED TO TREAT PERIAMPULLARY CARCINOMA IN THE COMMON BILE DUCT DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE STENT MIGRATED PROXIMALLY IMMEDIATELY AFTER DEPLOYMENT. THE STENT WAS NOT REMOVED FROM THE PATIENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763965 ↗