Protégé™ GPS™ SERB65-14-80-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684071786), received between Apr 28, 2017 and May 8, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2020Defective Component; Material Deformation; Defective Component; Material Deformation

  PHYSICIAN INTENDED TO USE A PROTEGE GPS DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENT¿S MID ILIAC VEIN. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND NO EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT THE STENT DEPLOYED SHORTER THAN STATED LENGTH BY APPROXIMATELY 20%. A DIFFERENT STENT WAS ALSO DEPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037897 ↗
• InjuryMar 27, 2018Inaccurate Delivery; Inaccurate Delivery

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE GPS STENT TO TREAT A LESION. THE VESSEL WAS NOT TORTUOUS. THE LESION WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE ADVANCING THE DEVICE. DURING THE DELIVERY OF THE STENT POSITIONING DIFFICULTIES WERE ENCOUNTERED. DURING DEPLOYMENT THE DELIVERY SYSTEM JAMMED AND THE STENT DEPLOYED OUTSIDE THE TARGET LESION. ANOTHER MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373540 ↗
• InjuryApr 28, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PHYSICIAN INTENDED TO USE A PROTÉGÉ GPS STENT DURING PROCEDURE FOR TREATMENT OF THE LEFT LIMB. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENT WAS DEPLOYED AND POST DILATED WITH A BALLOON. AS THE BALLOON WAS BEING REMOVED, THE STENT CAUGHT ON THE BALLOON AND MOVED. THE STENT WAS NOT REMOVED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. STENT MIGRATED WITH BALLOON INFLATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6529263 ↗