Stent FRED3511-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842429106662), received between May 14, 2021 and Dec 15, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2021Migration; Migration

  IT WAS REPORTED THAT THE FRED 27 STENT WAS USED IN AN ANEURYSM EMBOLIZATION PROCEDURE. UPON DEPLOYMENT, THE SENT APPEARED NORMAL AND IN THE CORRECT POSITION. POST DEPLOYMENT ANGIOGRAM SHOWED THE STENT MIGRATED DISTALLY FROM THE VERTEBRAL ARTERY INTO THE V-B JUNCTION AND NO LONGER COVERING THE ANEURYSM. THE DECISION WAS MADE TO PLACE A SECOND FRED DEVICE TO COVER THE ANEURYSM. A "J'D" SYNCRO SOFT WIRE WAS ATTEMPTED TO PASS THROUGH THE STENT TO FACILITATE THE SECOND FRED DEVICE. THE MOMENT THE WIRE TOUCHED THE INITIAL FRED STENT DEVICE, THE STENT MIGRATED FURTHER DISTALLY INTO THE MID-BASILAR SEGMENT. ATTEMPTS TO RETRIEVE THE STENT USING MULTIPLE TECHNIQUES INCLUDING SNARES WERE UNSUCCESSFUL. AFTER SEVERAL HOURS THE PHYSICIANS DECIDED TO MAKE ANOTHER ATTEMPT THE NEXT MORNING AND WAKE THE PATIENT UP TO ASSESS NEUROLOGICAL STATUS. THE PATIENT WAS PUT ON AN INTEGRILIN DRIP, BRILINTA, DOUBLE DOSE ASA AND FULL HEPARINIZATION. THE FOLLOWING MORNING ADDITIONAL ATTEMPTS WERE MADE AND THE FRED DEVICE WAS RETRIEVED WITH THE "LOOP AND SNARE TECHNIQUE." PATIENT SUFFERED A MINOR SUBARACHNOID HEMORRHAGE (SAH). CURRENT PATIENT CONDITION DESCRIBED AS "PATIENT IS NEUROLOGICALLY INTACT WITH NO FOCAL D

  Patient problems: Aneurysm

  MAUDE report 13014897 ↗
• InjuryMay 14, 2021Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED 27 3.5 X 17/11 WAS USED TO TREAT A PCOM ANEURYSM. THE PATIENT HAD NO SIGNIFICANT TORTUOSITY DISTAL OR PROXIMAL TO THE ANEURYSM. THE DISTAL MEASUREMENT WAS 2.8 MM AND PROXIMAL WAS 3.5 MM. THE ANEURYSM WAS FIRST COILED USING A HEADWAY DUO. THE MICROCATHETER WAS REMOVED TO INSERT THE HEADWAY 27 TO DEPLOY A FRED 27. THE DEVICE WAS DEPLOYED AT THE TERMINUS UTILIZING AN UNSHEATHING METHOD AND LANDED JUST DISTAL TO THE OPHTHALMIC ARTERY. FLOW THROUGH THE DEVICE WAS VISUALIZED. THE PHYSICIAN WANTED TO OBSERVE THE CONTRALATERAL SIDE AND STRONG FLOW ACROSS THE ACOM WAS VISUALIZED, WHICH WARRANTED MORE OBSERVATION ON THE DEVICE SIDE. A DSA INJECTION SHOWED THAT THE FRED DEVICE WAS OCCLUDED AT THE PROXIMAL PORTION OF THE DEVICE WITH NO FLOW DISTAL. INTRAVENOUS INTEGRILIN WAS ADMINISTERED AND FLOW WAS REPORTED TO BE SLOW AFTER 15 MINUTES. STRONG FLOW ACROSS THE ACOM FILLED THE AFFECTED SIDE AND THE ANTERIOR CHOROIDAL AND PCOM FILLED, BUT CLOT WAS STILL OBSERVED IN THE FRED DEVICE. PATIENT IS ON INTEGRILIN DRIP AND SHOWED SIGNS OF WEAKNESS ON CONTRALATERAL SIDE.

  Patient problems: Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 11828561 ↗