Protégé™ GPS™ SERB65-09-20-120 (UDI 00821684071397)Recalls & reported problems
Ev3, Inc · STENT SERB65-09-20-120 PROTEGE GPS V05 · Class 2 · Implant
All models of Protégé GPS (26)
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 00821684071397), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Premature Activation” (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
- Premature Activation1
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.
MalfunctionFeb 22, 2019Premature Activation; Premature Activation
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A PROTEGE GPS SELF-EXPANDING STENT WITH A 6FR SHEATH TO TREAT A LESION IN THE MID BILIARY ARTERY WITH NO TORTUOSITY OR CALCIFICATION. AN 0.035" WHOLEY WORE WAS USED. NO ISSUES WITH PACKAGING, NO ISSUES IN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED AS PER IFU. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED, PARTIAL DEPLOYMENT OCCURRED. THERE WAS NO DAMAGE TO THE DEPLOYMENT MECHANISMS OR DEVICE HANDLE PRIOR TO DEPLOYMENT ISSUE, THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE. THE LESION WAS NOT PRE-DILATED AND THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. THIS PATIENT HAD A BANDING PROCEDURE (OPEN-HEART) IMMEDIATELY PRECEDING THIS STENTING PROCESS. THE PHYSICIAN ADVANCED THE FIRST STENT WITH NO ISSUE. THE PATIENT BEGAN TO BLEED. AFTER THE CV SURGEON REPAIRED THE BLEEDING THE PHYSICIAN RESTARTED. THE PROTÉGÉ WOULDN'T ADVANCE. IT WAS THEN REPORTED THAT THE DISTAL EDGE OF THE STENT WAS OUT OF THE DELIVERY SYSTEM. A NEW STENT WAS OPENED, PREPPED AND DEPLOYED WITHOUT ISSUE. NO PATIENT INJURY REPORTED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8361086 ↗
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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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