Stent FRED3507-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429106655), received between Aug 14, 2020 and Nov 26, 2020 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Retraction Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2020Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AFTER THE FRED WAS DEPLOYED, THE DELIVERY WIRE BECAME CAUGHT ON THE STENT DURING RETRACTION. THE DELIVERY WIRE WAS ABLE TO RELEASE FROM THE STENT WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909405 ↗
• DeathSep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN UNRUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM. THE FRED DEVICE WAS PLACED IN THE ICA TO THE ORIGIN OF THE A1 SEGMENT, ACROSS THE MIDDLE CEREBRAL ARTERY (MCA). UPON COMPLETION OF THE PROCEDURE, IT APPEARED THAT THE MCA TERRITORY WAS NOT FILLING. THROMBUS WAS IDENTIFIED IN THE BLOOD VESSEL. INTEGRILIN WAS ADMINISTERED IMMEDIATELY, WHICH RESTORED FLOW WITHIN 15-20 MINUTES. IN SEVERAL HOURS AFTER THE PROCEDURE, AN INTRACEREBRAL HEMORRHAGE (ICH) WAS IDENTIFIED IN THE LEFT HEMISPHERE, WHICH WAS ON THE CONTRALATERAL SIDE FROM THE IMPLANTED DEVICE. THE PATIENT DIED THE NEXT DAY ON (B)(6) 2020 FROM A CEREBRAL HEMATOMA ON THE CONTRA-LATERAL SIDE. THE DEATH WAS REPORTED TO BE RELATED TO THE INTEGRILIN TREATMENT. NO DEVICE MALFUNCTION OR INFORMATION SUGGESTING THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AND PATIENT DEATH WAS REPORTED TO THE MANUFACTURER.

  Patient problems: Death; Hemorrhage, Cerebral; Thrombus

  MAUDE report 10497723 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ELECTIVE TREATMENT WAS PERFORMED FOR AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE PATIENT WAS ON DAPT (ASPIRIN AND BRILINTA). DEPLOYMENT OF THE FRED WENT WELL AND THE PATIENT DID WELL DURING THE PROCEDURE. 48 HOURS POST-PROCEDURE, THE PATIENT HAD A STROKE WITH SEVERE HAND WEAKNESS AND MILD ARM WEAKNESS ON THE LEFT. AN ANGIOGRAM WAS PERFORMED, WHICH DEMONSTRATED AN OCCLUSION WITHIN THE FRED. INTEGRILIN AND TPA WERE DELIVERED INTRA-ARTERIALLY WITHOUT EFFECT; HOWEVER, ANGIOGRAPHY SHOWED THERE WAS GOOD FLOW ACROSS THE ACOM, FILLING THE MCA TERRITORY, SO MECHANICAL THROMBECTOMY INSIDE THE STENT WAS NOT ATTEMPTED. THE STENT REMAINS COMPLETELY OCCLUDED. THE PATIENT HAS HAD SLOW IMPROVEMENT OF THE STROKE SYMPTOMS, BUT THERE ARE STILL REMAINING DEFICITS THAT ARE ANTICIPATED TO GET BETTER OVER WEEKS WITH REHAB AND TIME.

  Patient problems: Neurological Deficit/Dysfunction; Thrombus

  MAUDE report 10411670 ↗