Stent FRED3516-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106679), received between Jul 17, 2020 and Mar 29, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FRED STENT WAS IMPLANTED FROM THE M2 TO M1 SEGMENT OF THE MCA TO TREAT AN ANEURYSM OF THE BIFURCATION THAT WAS PREVIOUSLY CLIPPED AND HAD RECANALIZED. UPON WAKING FROM ANESTHESIA, THE PATIENT REPORTED LEFT SIDED WEAKNESS. THE PATIENT WAS BROUGHT BACK, "RE-ACCESSED," AND THROMBUS WAS OBSERVED ON THE OUTSIDE AND INSIDE OF THE AT THE OSTIUM FOR THE INFERIOR M2 DIVISION, WHICH THE STENT WAS CROSSING. A BOLUS OF INTEGRILIN WAS ADMINISTERED AS WELL AS AN INTEGRILIN INFUSION. THE THROMBUS RESOLVED AND BY THE NEXT MORNING THE PATIENT'S CONDITION WAS BACK TO BASELINE. IT WAS REPORTED THAT THE PATIENT COULD BE A PLAVIX NONRESPONDER.

  Patient problems: Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 13935510 ↗
• InjuryAug 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ON (B)(6) 2021 A FRED STENT WAS SUCCESSFULLY IMPLANTED TO TREAT A LEFT VERTEBRAL ARTERY ANEURYSM. ON (B)(6) 2021, THE PATIENT RETURNED TO THE HOSPITAL WITH STROKE LIKE SYMPTOMS. THE STENT HAD FORMED THROMBUS WHICH WAS REMOVED WITH AN ASPIRATION CATHETER. THE PATIENT WAS PLACED ON AN INTEGRILLIN DRIP OVERNIGHT.

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 12292094 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS A FLOW DIVERSION OF THE RIGHT ICA. THE PROCEDURE WAS ON LABEL AND PROCTORED BY THE PHYSICIAN. THE PATIENT WAS ON DAPT THERAPY WITH A PRU IN OPTIMAL RANGE MEASURED JUST PRIOR TO PROCEDURE. THE PROCEDURE WAS UNREMARKABLE WITH NO PERI-PROCEDURAL COMPLICATIONS. SEVERAL HOURS AFTER PROCEDURE, THE PHYSICIAN NOTICED PATIENT ABNORMALITIES (MILD EXPRESSIVE APHASIA) DURING EXAM IN POST-OPERATIVE ICU. THE PATIENT WAS TAKEN BACK TO IR FOR INTERVENTION TO PERFORM ANGIOGRAPHY. CLOT FORMATION WAS NOTICED NEAR THE FRED DEVICE DURING ANGIOGRAPHY, THROMBECTOMY WAS ATTEMPTED. IN ADDITION, THE PHYSICIAN NOTICED THE IMPLANTED FRED DEVICE HAD EXPERIENCED PROXIMAL FORESHORTENING AND/OR SLIGHT DISTAL MIGRATION. THE PHYSICIAN ATTEMPTED CLOT ASPIRATION WITH NO SUCCESS. AN ATTEMPT TO CROSS THE FRED FLOW DIVERTER WITH MULTIPLE DEVICES WITH NO SUCCESS. THE PATIENT WAS TREATED WITH INTEGRILIN WITH A PLAN TO SWITCH PATIENT FROM PLAVIX / ASPIRIN TO BRILLINTA / ASPIRIN. PATIENT EXPERIENCED MILD EXPRESSIVE APHASIA.

  Patient problems: Speech Disorder; Thrombosis/Thrombus

  MAUDE report 11828705 ↗
• InjuryDec 22, 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 INTERNAL CAROTID ARTERY (ICA), THROMBUS DEVELOPED WITHIN THE STENT AND THE MIDDLE CEREBRAL ARTERY (MCA) BECAME OCCLUDED. HEPARIN WAS INCREASED AND TPA WAS ADMINISTERED, WHICH IMPROVED FLOW IN THE MCA. THE FRED DEVICE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11061543 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FRED WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT IN THE LEFT INTERNAL CAROTID ARTERY (ICA) TO TREAT A PARAOPHTHALMIC ANEURYSM. POST-PROCEDURE ANGIOGRAMS IDENTIFIED AN ANTERIOR INTERNAL CAROTID ARTERY (AICA) ANEURYSM, WHICH WAS TREATED WITH NON-MICROVENTION DEVICES, AND A FISTULA COMPONENT OF THE AICA ANEURYSM WAS IDENTIFIED. AN ATTEMPT WAS MADE WITH NON-MICROVENTION DEVICES TO ACCESS THE VESSEL ASSOCIATED WITH THE FISTULA, RESULTING IN CONTRAST EXTRAVASATION THAT WAS TREATED WITH ONYX LIQUID EMBOLIC. FOLLOW-UP ANGIOGRAMS THEN DEMONSTRATED THROMBUS WITHIN THE FRED STENT. ACCESS TO THE FRED WAS ATTEMPTED WITH A WIRE AND A CATHETER (NON-MICROVENTION DEVICES) AND THE FRED BECAME "BUNCHED" IN THE PROXIMAL SEGMENT. THE STENT WAS NOT ABLE TO BE ACCESSED TO DIRECTLY TREAT THE THROMBUS. THE PATIENT WAS ON AN AGGRASTAT DRIP. THE PARAOPHTHALMIC ANEURYSM WAS ACCESSED AND TREATED WITH THREE (3) COILS (NON-MICROVENTION). FINAL ANGIOGRAMS CONFIRMED GOOD CONTRALATERAL FLOW THROUGH THE ANTERIOR COMMUNICATION ARTERY (ACOM). THE PATIENT WAS SHUNTED DUE TO THE POSTERIOR BLEED. THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE."

  Patient problems: Thrombus

  MAUDE report 10292581 ↗