Protégé™ GPS™ SERB65-10-80-120 (UDI 00821684071571)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684071571), received between May 17, 2017 and Jun 27, 2018 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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.

• DeathJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IN THIS INCIDENT HAD A TOTAL RIGHT PROXIMAL TO MID ILIAC OCCLUSION THAT WAS APPROACHED RETROGRADE ON THE RIGHT SIDE. THE VESSEL WAS PRE-DILATED. THE TARGET LESION WAS A CTO (CHRONIC TOTAL OCCLUSION-100%) WITH SEVERE CALCIFICATION. THE VESSEL WAS MODERATELY TORTUOUS. A VIANCE CATHETER WAS INITIALLY USED TO TRY AND CROSS THE LESION BUT WENT SUB-INTIMAL AND POTENTIALLY OUTSIDE THE VESSEL IN THIS ATTEMPT BELOW THE OCCLUSION. A GUIDE WIRE AND RE-ENTRY CATHETER WERE USED SUCCESSFULLY TO EVENTUALLY NAVIGATE PAST THE LESION AND RE-ENTER THE ILIAC. TREATMENT TO THE PROXIMAL RIGHT ILIAC THEN WAS ORIGINALLY APPROACHED WITH THE THOUGHT IN MIND OF USING A PROTÉGÉ GPS ON THE OSTIAL AND PROXIMAL ILIAC WITH THE GOAL OF NOT COMPROMISING OR JAILING THE INTERNAL ILIAC. A 10X80 PROTÉGÉ GPS WAS DEPLOYED SUCCESSFULLY. AN EVERFLEX 8X80 WAS USED TO TREAT A STENOSIS ON THE LEFT ILIAC SUCCESSFULLY AS WELL. IT WAS THEN NOTED THE PATIENT¿S BLADDER LOOKED COMPRESSED, A TYPICAL SIGN OF AN INTERNAL BLEEDING SITUATION. A NON-MDT COVERED STENT WAS PLACED DISTAL TO THE 10X 80 PROTÉGÉ IN THE RIGHT ILLIAC WHERE THE BLEED APPEARED TO BE AND THIS SEEMED TO RESOLVE THE ISSUE. UPON FURTHER EXAMINATION O

  Patient problems: Death; Perforation

  MAUDE report 7640839 ↗
• MalfunctionMay 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS STENT TO TREAT AN UNKNOWN LESION. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR MEASUREMENT PRIOR TO PROCEDURE. PRIOR TO ATTEMPTING TO DEPLOY THE STENT, WHEN UNSCREWING THE PIN PULL DEPLOYMENT, IT WAS REPORTED THAT THE WHOLE ASSEMBLY CAME APART. A SECOND PROTÉGÉ GPS STENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT SIMILAR ISSUES WERE ENCOUNTERED WITH THE SECOND STENT ALSO, BUT THAT THE PHYSICIAN MANAGED TO SUCCESSFULLY DEPLOY THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574260 ↗
• MalfunctionMay 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A PROTÉGÉ GPS STENT TO TREAT AN UNKNOWN LESION. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR MEASUREMENT PRIOR TO PROCEDURE. PRIOR TO ATTEMPTING TO DEPLOY THE STENT, WHEN UNSCREWING THE PIN PULL DEPLOYMENT, IT WAS REPORTED THAT THE WHOLE ASSEMBLY CAME APART. A SECOND PROTÉGÉ GPS STENT WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT SIMILAR ISSUES WERE ENCOUNTERED WITH THE SECOND STENT ALSO, BUT THAT THE PHYSICIAN MANAGED TO SUCCESSFULLY DEPLOY THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574257 ↗