Stent FRED2508-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106570), received between Oct 22, 2020 and Nov 18, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Collapse” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED 21 DEVICE WAS SUCCESSFULLY IMPLANTED TO TREAT A FUSIFORM ANEURYSM IN ESTIMATED 2MM VESSEL. UPON ANGIOGRAPHIC REVIEW, THE ANATOMY LOOKED CLEAR AND STENT WAS WELL OPPOSED TO THE VESSEL WALLS. POST PROCEDURE, THE PATIENT HAD DIFFICULTY WAKING UP AND WAS NOT RESPONSIVE ON THE RIGHT SIDE OF THE BODY. CT SHOWED MINOR CLOT WITHIN THE FRED DEVICE AND DISTAL TO DEVICE. THE PATIENT WAS TAKEN BACK TO IR AND GIVEN IA TPA, WHICH RESOLVED THE CLOT. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED AS ORIGINALLY PLANNED. PRU LEVEL DURING THE INITIAL PROCEDURE WAS 150.

  Patient problems: Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 12837216 ↗
• InjuryJul 20, 2021Collapse; Migration; Collapse; Migration

  IT WAS REPORTED THAT THE FRED 21 STENT WAS USED TO TREAT A RIGHT MCA (M1) ANEURYSM. THE DEVICE WAS FULLY DEPLOYED INTO M1 FULLY COVERING THE ANEURYSM WITH PROXIMAL FLARED ENDS INTO ICA BIFURCATION. ON SUBSEQUENT RUN, IT WAS NOTICED THAT THE DEVICE HAD JUMPED DISTALLY AND WAS NO LONGER COVERING THE ANEURYSM WITH PROXIMAL FLARED-END JUMPING INTO ANEURYSM. CLOT FORMED IN THE CENTER OF THE STENT. IA INTEGRILIN WAS ADMINISTERED, BUT DID NOT SEEM TO HELP. PHYSICIAN TRIED TO CROSS THE STENT TO PLACE ANOTHER DEVICE WITHIN THE FIRST FRED 21 BUT COULD NOT RE-ACCESS THE LUMEN POSSIBLY DUE TO SOME SORT OF BUNCHING IN THE CENTER OF THE STENT. SUBSEQUENT IMAGING SHOWED ABNORMAL APPEARANCES OF THE FRED 21 DEVICE. PROCEDURE WAS STOPPED AND INTEGRILIN DRIP WAS STARTED. ADDITIONAL INFORMATION RECEIVED UPON FOLLOW-UP INDICATED THE STENT APPEARED COLLAPSED AT 5.4MM AND CLOTTED AGAIN. THE PATIENT HAD A STROKE AND IS PARALYZED ON THEIR LEFT SIDE.

  Patient problems: Ischemia Stroke; Paralysis; Thrombosis/Thrombus

  MAUDE report 12200471 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTING WITH A RUPTURED BLISTER ANEURYSM OF THE DISTAL ANTERIOR CEREBRAL ARTERY WAS TREATED WITH A FRED 21 FLOW DIVERTER STENT. THE FRED 21 WAS DEPLOYED WITHOUT ISSUE AND IMMEDIATE ANGIOGRAPHY SHOWED NO ISSUES. ON THE THIRD POST-DEPLOYMENT ANGIOGRAM AT THE 15-MINUTE MARK, A SMALL AMOUNT OF THROMBUS BEGAN TO DISPLAY ON THE FRED 21'S DISTAL FINISHED ENDS BETWEEN THE DISTAL-MOST MARKER AND FLOW DIVERTING PORTION. A FULL BODY WEIGHT DOSE OF EPTIFIBATIDE WAS GIVEN, WHICH INSTANTLY RESOLVED THE THROMBUS FORMATION. SERIAL ANGIOGRAMS WERE AGAIN PERFORMED FOR 30 MINUTES AFTERWARD, WHICH SHOWED NO ADDITIONAL THROMBUS FORMATION. NO FURTHER ISSUES WERE OBSERVED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11721264 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE FRED TO TREAT AN ANEURYSM IN A STENOTIC LEFT POSTERIOR CEREBRAL ARTERY (PCA), THROMBUS DEVELOPED WITHIN THE STENT. TPA WAS ADMINISTERED TO DISSOLVE THE THROMBUS AND DISTAL FLOW THROUGH THE PCA WAS CONFIRMED. THERE WAS NO REPORTED MALFUNCTION OF THE FRED. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11182109 ↗
• MalfunctionOct 22, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE FRED, 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 OR INTERVENTION. THE PATIENT IS REPORTED TO BE "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10722115 ↗