TIGRIS Vascular Stent PHA051002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132636198), received between Aug 10, 2018 and Sep 25, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionSep 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  DURING TREATMENT IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) DUE TO OCCLUSIVE DISEASE, A GORE® TIGRIS® VASCULAR STENT (STENT) WAS ADVANCED AFTER THE ARTERY WAS PREDILATED BY A 3MM BALLOON. IT WAS REPORTED THAT DURING ADVANCEMENT, THERE WAS DIFFICULTY PUSHING THE DELIVERY CATHETER PAST THE PROXIMAL SFA. THE PHYSICIAN REALIZED THAT ABOUT 2CM OF THE STENT WAS UNSHEATHED AT THE DISTAL TIP AND THE CONSTRAINT SLEEVE APPEARED TO BE DISPLACED. THE DELIVERY CATHETER WAS PULLED BACK THROUGH THE INTRODUCER SHEATH AND REMOVED FROM THE PATIENT. AS REPORTED, THE CONSTRAINT SLEEVE LIKELY GOT STUCK ON VESSEL PLAQUE AS THE DEVICE WAS PUSHED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119530 ↗
• MalfunctionAug 21, 2018Positioning Failure; Activation, Positioning or Separation Problem; Positioning Problem; Positioning Failure; Activation, Positioning or Separation Problem; Positioning Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A SFA OCCLUSION CASE, THE FIRST GORE® TIGRIS® VASCULAR STENT WAS IMPLANTED WITHOUT INCIDENT. AS THE SECOND GORE® TIGRIS® VASCULAR STENT WAS BEING ADVANCED THROUGH THE PREVIOUSLY IMPLANTED GORE® TIGRIS® VASCULAR STENT, THE DOCTOR REPORTED THE DEVICE APPEARED TO PARTIALLY DEPLOY AND THEN BEGAN TO 'ACCORDION'. THE DEVICE WAS REMOVED WITHOUT INCIDENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 2 ADDITIONAL GORE® TIGRIS® VASCULAR STENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803265 ↗
• MalfunctionAug 10, 2018Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF A HEAVILY CALCIFIED POPLITEAL ARTERY STENOSIS WITH A GORE® TIGRIS® VASCULAR STENT. AN ANTEGRADE APPROACH WAS UTILIZED. THE DEVICE WAS ADVANCED OVER A .035" WOOLY WIRE THROUGH A 6FR TERUMO SHEATH. WHEN THE TARGET LOCATION WAS REACHED DEPLOYMENT WAS INITIATED. APPROXIMATELY 3-4 CM OF THE DEVICE EXPANDED WHEN DEPLOYMENT STOPPED. THE DEPLOYMENT LINE SNAPPED, HOWEVER NO RESISTANCE WAS FELT PRIOR IN THE DEPLOYMENT WHEEL. THEN THE DEPLOYMENT WHEEL WAS TURNING WITHOUT ADDITIONAL DEVICE EXPANSION. THE DELIVERY CATHETER WAS THEN CUT OPEN IN ATTEMPTS TO RETRIEVE THE DEPLOYMENT LINE, BUT THIS WAS NOT SUCCESSFUL. THE SHEATH WAS ADVANCED FURTHER TO TRY AND CAPTURE THE DEVICE, WHICH WAS EVENTUALLY SUCCESSFUL. THE PROCEDURE WAS COMPLETED USING A BARE METAL BARD LIFESTENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7774668 ↗