Stent FRED4007-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00842429106709), received between Mar 27, 2020 and Dec 9, 2021 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 7, 2023Open, Classified

   Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

   Z-2238-2023 · Root cause: Process control · FDA record ↗

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 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED 27 STENT WAS IMPLANTED IN THE PATIENT WITHOUT ISSUE. THE PATIENT WAS PLACED ON DUAL ANTIPLATELET THERAPY AND DID RESPOND TO IT. AT THE SIX MONTH FOLLOW UP, THE LUMEN OF THE FRED HAD CLOSED OFF DUE TO THROMBUS. THERE ARE NO PATIENT HEALTH DEFICITS AND NO INTERVENTION IS PLANNED. THERE WAS CROSS-FILL THROUGH THE ACOM ARTERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12972455 ↗
• InjuryNov 16, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNRUPTURED RIGHT PARCLINOID ICA ANEURYSM. A FRED FLOW DIVERSION STENT WAS SELECTED AND PLACED SUCCESSFULLY ACROSS THE NECK OF THE ANEURYSM WITH GOOD WALL APPOSITION AND POSITIONING OF THE STENT. 12 DAYS POST IMPLANTATION, THE PATIENT RETURNED COMPLAINING OF HEADACHE. CT ANGIOGRAM DEMONSTRATED MIGRATION OF THE FRED STENT INTO THE MIDDLE CEREBRAL ARTERY. DIAGNOSTIC INTERVENTION WAS PERFORMED 4 DAYS LATER THAT CONFIRMED THE STENT MIGRATED TO THE DISTAL M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE RIGHT PARACLINOID ICA ANEURYSM IS PATENT, BUT IT REMAINS. THERE WAS NO EVIDENCE OF INTRACRANIAL HYPERTENSION. PER THE PHYSICIAN, THE PATIENT WAS DISCHARGED AND DOING "GOOD." THE PATIENT HAS BASELINE LEFT SIDE DEFICIT. THE PHYSICIAN WANTS THE FRED TO ENDOTHELIAZE FOR 6 MONTHS AND THEN WILL TREAT WITH A PIPELINE.

  Patient problems: Aneurysm; Headache

  MAUDE report 12824424 ↗
• InjuryJun 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A THROMBOTIC OCCLUSION AND VERTEBRAL ARTERY ANEURYSM. THREE DAYS AFTER THE STENTING, PARALYSIS WAS OBSERVED IN THE PICA TERRITORY. ANGIOGRAPHY REVEALED AN OCCLUSION OF THE STENTED PART OF THE VERTEBRAL ARTERY WHERE THE FRED WAS IMPLANTED. DURING STENTING, THE PATIENT WAS CONFIRMED TO BE A LOW RESPONDER TO CLOPIDOGREL, SO CILOSTAZOL WAS ADMINISTERED INSTEAD OF ASPIRIN. NO OTHER ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN A "SERIOUS CONDITION," BUT THEY RECOVERED.

  Patient problems: Paralysis; Thrombosis/Thrombus

  MAUDE report 12072300 ↗
• InjuryMay 28, 2021Activation Failure; Migration; Activation Failure; Migration

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED TO TREAT A SUPRACLINOID WIDE NECK ANEURYSM. IMMEDIATE POST IMPLANTATION IMAGING SHOWED GOOD WALL APPOSITION, ANEURYSM STATUS, AND GOOD PERFUSION. THREE MINUTES LATER, A SECOND ANGIO RUN WAS PERFORMED AND THERE WAS COMPLETE OCCLUSION OF FRED WITH NO DISTAL PERFUSION AND THE DEVICE APPEARED TO HAVE THROMBUS AFFIXED TO IT. AFTER TAKING ADDITIONAL SPOT FLUORO IMAGES, THE DEVICE DID NOT APPEAR FULLY OPEN, IT HAD FORESHORTENED, AND IT HAD ALSO MIGRATED PROXIMALLY. AGGRASTAT IA WAS ADMINISTERED AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TWICE. A SECOND FRED STENT WAS IMPLANTED SINCE THE FIRST STENT WAS NO LONGER COVERING THE ANEURYSM. ANGIO SHOWED GOOD WALL APPOSITION AND REPERFUSION, BUT THROMBUS CONTINUED TO FORM. FURTHER MEDICATION WAS ADMINISTERED AND PTA WAS PERFORMED, BUT CLOT CONTINUED TO FORM. THE PHYSICIAN REPEATED PTA MULTIPLE TIMES AND AFTER WAITING 15 MINUTES, PATIENT HAD ADEQUATE FLOW. THE PHYSICIAN DECIDED TO STOP THE CASE AND SEE HOW THE PATIENT WOKE UP. POST ANESTHESIA, THE PATIENT WOKE UP MOVING ALL EXTREMITIES AND WAS ABLE TO SPEAK. THIS EVENT REFERS TO THE FIRST STENT IMPLANTED.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 11904851 ↗
• DeathApr 9, 2021Migration; Migration

  IT WAS REPORTED THAT A FRED 27 STENT WAS PLACED FOR THE TREATMENT OF AN UNRUPTURED ANTERIOR CHOROIDAL ANEURYSM. THE FRED STENT WAS DEPLOYED SUCCESSFULLY AND APPEARED TO HAVE GOOD WALL APPOSITION. ON A FINAL ANGIOGRAPHIC RUN, THE FRED WAS OBSERVED TO BE POSITIONED ROUGHLY 2-3MM DISTAL INTO THE MIDDLE CEREBRAL ARTERY (MCA) WITH SLOW FLOW. ADDITIONAL ANGIOGRAPHIC RUNS REVEALED AN OCCLUSION OF THE MCA DUE TO THROMBOSIS OF THE VESSEL. THE PHYSICIAN ATTEMPTED TO REMOVE AND RECAPTURE THE FRED. AN INTRAOPERATIVE BLEED OCCURRED DURING THE MANIPULATIONS WITHIN THE BLOOD VESSEL AND THE PHYSICIAN THEN COILED THE ICA TO STOP IT. AN EXTERNAL VENTRICULAR DRAIN WAS PLACED TO DRAIN BLOOD. THE PATIENT LATER PASSED AWAY.

  Patient problems: Intracranial Hemorrhage; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11646247 ↗
• MalfunctionOct 19, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE FRED WAS PLACED WITHIN ANOTHER FRED DURING TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AFTER THE FRED WAS DEPLOYED, THE DELIVERY WIRE BECAME CAUGHT ON THE STENT DURING RETRACTION. THE DELIVERY WIRE RELEASED FROM THE FRED WITH ADDITIONAL MANIPULATION OF THE WIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10702541 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. THE FRED WAS SUCCESSFULLY IMPLANTED AND EMBOLIZATION COILS WERE SUBSEQUENTLY PLACED IN THE ANEURYSM. DURING THE COIL INSERTION, CLOT BEGAN TO DEVELOP ON THE PROXIMAL PORTION OF THE FRED. INTEGRILIN WAS ADMINISTERED TO THE PATIENT THROUGH THE MICROCATHETER AND THE THROMBUS RESOLVED. THERE WAS NO REPORTED PATIENT INJURY OR SEQUELAE. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10517219 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY (ICA) TO COVER A SMALL SIDE WALL ANEURYSM. ANGIOGRAPHY CONFIRMED THE FRED WAS OPENED DISTALLY AND PROXIMALLY. AFTER THE CASE, THE PATIENT DEVELOPED A CLOT INSIDE THE STENT. A REPERFUSION CATHETER WAS USED TO ASPIRATE AND SUCCESSFULLY REMOVE THE CLOT; HOWEVER, THE END OF THE FRED BECAME BENT AND THE STENT WAS "PUSHED INTO" THE ANEURYSM. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Thrombus

  MAUDE report 9892064 ↗