Protégé™ GPS™ SERB65-10-60-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071557), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Use of Device 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.

• MalfunctionFeb 6, 2019Use of Device Problem; Use of Device Problem

  THE PHYSICIAN ATTEMPTED TO USE A PROTEGE GPS STENT TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION IN THE MID COMMON ILIAC ARTERY. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS NOT PRE-DILATED. THERE WAS NO RESISTANCE ADVANCING THE DEVICE AND IT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. PRIOR TO THE STENT DEPLOYMENT, THE LOCK-PIN WAS REMOVED AND THE STENT FAILED TO DEPLOY. THE PHYSICIAN REPORTED THE STENT WAS DIFFICULT TO OPEN. ANOTHER PROTEGE GPS OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310456 ↗