Advanix™ Pancreatic Stent M00536660Recalls & reported problems
Boston Scientific Corporation · Pancreatic Stent · Class 2 · Implant
All models of Advanix Pancreatic Stent (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729857600), received between Nov 14, 2016 and Nov 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 2026.
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2016Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMMERCIAL BSC PLASTIC STENT WAS IMPLANTED IN PANCREATIC DUCT OF THE PATIENT ON (B)(6) 2016 AS PART OF (B)(6). ON (B)(6) 2016 AN ADVANIX PANCREATIC STENT WAS IMPLANTED IN THE PATIENT. DURING THE PLACEMENT PROCEDURE, PROPHYLACTIC NSAIDS WERE ADMINISTERED VIA RECTAL INDOMETHACIN. A PRIOR BILIARY SPHINCTEROTOMY AND PANCREATIC SPHINCTEROTOMY WERE PERFORMED. A PREVIOUSLY PLACED PANCREATIC STENT WAS REMOVED AT THE TIME OF THE PROCEDURE. IN ADDITION TO STENT PLACEMENT THE FOLLOWING WERE ALSO CONDUCTED: PANCREATIC STONE EXTRACTION (OTHER THAN BY ESWL), BALLOON SWEEP, AND BALLOON DILATION. CONTRAST WAS INJECTED INTO THE PANCREATIC DUCT THE ENTIRE LENGTH OF MAIN PANCREATIC DUCT INTO TAIL OF PANCREAS. THE PANCREATIC DUCT WAS DILATED 8MM, AND THE INTENDED DURATION OF INDWELL IS GREATER THAN 8 WEEKS. ON (B)(6) 2016 DURING A PLANNED STENT REMOVAL PROCEDURE, THE BSC PLASTIC STENT WAS REMOVED FROM THE PATIENT USING A SNARE, GRASPER, AND OTHER (NO SPECIFICS REPORTED). IT WAS REPORTED THAT THE STENT HAD EXPERIENCED A COMPLETE PROXIMAL MIGRATION WHICH WAS NOT DESIRED BY THE SITE. ADDITIONALLY, THE STENT WAS DIFFICULT TO REMOVE FROM THE PATIENTS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6099115 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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