Protégé™ GPS™ SERB65-14-40-80Recalls & reported problems
Ev3, Inc · STENT SERB65-14-40-80 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684071748), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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
- Migration or Expulsion of Device1
Patient problems
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device
PHYSICIAN INTENDED TO USE A PROTÉGÉ GPS SELF-EXPANDING STENT SYSTEM WITH A 9FR NON-MEDTRONIC SHEATH AND 0.035 WIRE TO TREAT AN 80MM FIBROUS LESION IN THE PATIENT¿S PROXIMAL LEFT ILIAC VEIN OF DIAMETER 14MM. LESION EXHIBITED 70% STENOSIS. SLIGHT VESSEL TORTUOSITY REPORTED. NO DAMAGE NOTED TO PRODUCT PACKAGING PRIOR TO USE. NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING. VESSEL PRE-DILATION WAS NOT PERFORMED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. STENT WAS PLACED. ANGIOGRAM WAS PERFORMED WHICH SHOWED THE STENT HAD MIGRATED TO THE PATIENT¿S INFERIOR VENA CAVA (IVC) BY EITHER THE IVUS CATHETER PUSHING IT UP OR PTA. TWO ADDITIONAL STENTS WERE PLACED, ONE PROTÉGÉ AND ONE NON-MEDTRONIC. POST PROCEDURE THE PATIENT COMPLAINED OF CHEST PAIN AND WAS TRANSPORTED TO HOSPITAL. AN X-RAY WAS TAKEN WHICH SHOWED THE STENT HAD MIGRATED TO THE HEART. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL AND THE STENT WAS REMOVED WITH A SNARE USING AN INTERNAL JUGULAR (IJ) APPROACH. THE PATIENT IS REPORTED TO BE DOING WELL AND HAS NO ISSUES OR COMPLICATIONS.
Patient problems: Chest Pain
MAUDE report 9731745 ↗
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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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