Stent FRED2513-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842429106587), received between Apr 10, 2020 and Dec 28, 2023 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A FRED 21 FLOW DIVERTER STENT WAS PLACED ACROSS THE NECK OF A RIGHT PERICALLOSAL ANEURYSM. AFTER SEVERAL CONTRAST RUNS, IT WAS DETERMINED THERE WAS CLOT FORMATION IN ARTERY. BRILINTA MEDICATION WAS ADMINISTERED TO BREAK UP THE CLOT FORMATION. THE PATIENT IS FINE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18415741 ↗
• DeathFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED 21 FLOW DIVERTER STENT WAS USED OFF-LABEL TO TREAT A SITE AT THE ANTERIOR COMMUNICATING ARTERY (ACOM). THE PHYSICIAN REPORTED THAT BASED ON HIS VISUALIZATION, THE FRED STENT OPENED DISTALLY AND WAS OPEN AND OPPOSED TO THE WALL; HOWEVER, THIS COULD NOT BE CONFIRMED BY IMAGING DUE TO THE PATIENT'S BONE STRUCTURE, AND THE IMAGING ANGLE AND POOR QUALITY. IT WAS LATER DISCOVERED, AFTER CHANGING ANGLES OF IMAGE AND DOING A FINAL RUN, THAT THE CENTRAL PORTION OF THE FRED STENT WAS NOT FULLY OPENED. MULTIPLE ATTEMPTS WERE MADE TO TRY TO ACCESS THE CENTRAL PORTION OF THE STENT TO OPEN IT, BUT THEY WERE UNSUCCESSFUL. THE VESSEL OCCLUDED, BUT CROSS FILL WAS PROVIDED TO THE DISTAL PORTION BEYOND THE OCCLUSION FROM ANOTHER BRANCH VESSEL. THE PHYSICIAN ENDED THE CASE WITH FULL FLOW BEYOND THE STENT OCCLUSION. REPORTEDLY, THE PATIENT LATER DIED THAT EVENING FROM COMPLICATIONS RELATED TO THROMBUS. THERE IS NO INDICATION OF DEVICE ISSUE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13592658 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UNSPECIFIED PROCEDURE, THE FRED FLOW DIVERTER STENT WAS POSITIONED AND DEPLOYED WITHOUT ISSUE. IMMEDIATE CTA RUN LOOKED GOOD, AND THE VESSEL LOOKED PATENT. SUBSEQUENT DELAYED RUNS SHOWED PROGRESSIVE SLOWER FLOW WITH EVENTUAL ZERO PATENCY OF VESSEL AND INTRA-ARTERIAL INTEGRELIN WAS ADMINISTERED. REPORTEDLY, THE ANATOMY WAS CHALLENGING WITH SOME TORTUOSITY TO OVERCOME AND SOME VASOSPASM WAS NOTED AND TREATED DURING THE PROCEDURE. POST PROCEDURE THE PATIENT WAS STABLE WITH SLIGHT LEFT SIDE WEAKNESS.

  Patient problems: Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 12455239 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED JR. STENT WAS IMPLANTED TO TREAT AN ANEURYSM OF THE FETAL POSTERIOR CEREBRAL ARTERY. THE STENT WAS DEPLOYED WITHOUT ISSUE AND STASIS WAS OBSERVED TO BE FORMING INSIDE OF THE ANEURYSM. FOUR HOURS POST PROCEDURE, THROMBUS WAS OBSERVED TO BE FORMING INSIDE OF THE STENT. BALLOON ANGIOPLASTY WAS PERFORMED, WHICH RESTORED FLOW, BUT THE STENT CONTINUED TO FORM THROMBUS. IT WAS THE PHYSICIAN'S BELIEF THAT THE CLOT FORMATION INSIDE THE ANEURYSMAL SAC WAS SO SEVERE THAT IT WENT DOWN INTO THE FRED JR. A FOLLOW-UP THE NEXT DAY SHOWED RE-PROFUSION, BUT THE PATIENT HAD ALREADY HAD A STROKE AND THEY WERE BLIND ON RIGHT SIDE. INTEGRILIN WAS ADMINISTERED.

  Patient problems: Ischemia Stroke; Loss of Vision; Thrombosis/Thrombus

  MAUDE report 11943493 ↗
• InjuryMay 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT A FRED 21 STENT WAS SUCCESSFULLY DEPLOYED IN THE ANTERIOR CEREBRAL ARTERY AND THE ANEURYSM HAD STAGNANT FLOW. EIGHT DAYS POST PROCEDURE, CTA SHOWED THAT THE VESSEL WAS NOT FILLING, THE STENT HAD COMPRESSED, AND THE PATIENT HAD INFARCTION IN THE REGION OF TREATMENT. THE PATIENT IS NOW IN REHABILITATION AND THE PHYSICIAN PREDICTS THEIR CONDITION SHOULD IMPROVE.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11898189 ↗
• InjuryApr 15, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED TO TREAT A RUPTURED ANEURYSM LOCATED AT THE BIFURCATION OF THE PERICALLOSAL AND CALLOSOMARGINAL ARTERIES. THE FRED MOVED DURING UNSHEATHING BUT ULTIMATELY COVERED THE ANEURYSM. A FILLING DEFECT WAS NOTICED IN THE CALLOSOMARGINAL ARTERY AMD INTEGRILLIN WAS ADMINISTERED. THE FILLING DEFECT WAS THEN OBSERVED TO BE RESOLVED. THE PATIENT WAS PLACED ON CANGRELOR POST PROCEDURE AND WOKE UP WITH NO NEUROLOGICAL DEFICIT. MRI SHOWED NO INFARCT THE FOLLOWING DAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11676287 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED DEVICE IN THE POSTERIOR CEREBRAL ARTERY (PCA), BLOOD FLOW WAS REDUCED IN THE DISTAL PAC AND INTEGRILIN WAS ADMINISTERED. EFFORTS WERE MADE TO RETRIEVE THE FRED FROM THE PATIENT, BUT THEY WERE UNSUCCESSFUL AND THE DEVICE REMAINS IMPLANTED. THE PATIENT IS CURRENTLY REPORTED TO BE "OK" AND IS RECOVERING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11042507 ↗
• DeathApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED WAS IMPLANTED ON (B)(6) 2020 AS TREATMENT FOR AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE FRED PERFORMED AS EXPECTED AND WAS PLACED IN AN OPTIMAL POSITION IN THE VESSEL. THERE WERE NO PATIENT OR DEVICE COMPLICATIONS DURING THE PROCEDURE. FOLLOW-UP ANGIOGRAMS WERE TAKEN UP TO 30 MINUTES POST-PROCEDURE, AND THERE DID NOT APPEAR TO BE THROMBUS IN THE VESSEL OR WITHIN THE STENT, OR EVIDENCE OF A BLEED. ON (B)(6) 2020, CT IMAGING DEMONSTRATED THROMBUS WITHIN THE STENT. THE PATIENT WAS TAKEN TO THE CATH LAB AND THE CLOT WAS TREATED AND RESOLVED. IT WAS REPORTED THAT THE NEXT DAY THE PATIENT HAD A BLEED AND WAS TAKEN TO THE OPERATION ROOM. THE FOLLOWING DAY, THE PATIENT EXPIRED. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

  Patient problems: Death; Thrombus

  MAUDE report 9950989 ↗