Protégé™ GPS™ SERB65-10-80-80 (UDI 00821684071588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071588), received between Sep 22, 2017 and Sep 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE ONE PROTEGE GPS BILIARY STENT TO TREAT A CALCIFIED LESION IN THE PORTAL VEIN. THE IFU WAS FOLLOWED DURING THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS TESTED PRIOR TO USE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN FELT RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE PHYSICIAN FELT THE RESISTANCE WAS DUE TO PATIENT ANATOMY. IT WAS REPORTED THAT WHEN ADVANCING THE DEVICE, THE STENT WAS DEPLOYED AT AN INEXACT LOCATION. THE STENT WAS DEPLOYED AND THE PHYSICIAN REMOVED THE DEVICE WITHOUT DIFFICULTY. ANOTHER STENT WAS THEN DEPLOYED TO COVER THE TARGET LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887136 ↗