Stent FREDX2513-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429114216), received between Jul 25, 2022 and Dec 19, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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 18, 2026.

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.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS BROUGHT THE ANGIO SUITE FOR SCHEDULED TREATMENT OF THE MCA VASCULATURE WITH A FLOW DIVERTER. ACCESS WAS GAINED AND DEVICE WAS SELECTED, THE SEGMENT TO BE TREATED WAS THE MCA VESSEL, THE DOCTOR SUCCESSFULLY IMPLANTED A 2.5X13/ 8 FLOW DIVERTER IN THE VESSEL, AFTER CAREFUL MEASUREMENTS OF THE VESSEL 2.4MM DISTAL-2.6MM PROXIMAL THE 13/8 WAS SELECTED TO FIT IN BETWEEN THE VESSEL PERFORATORS. THE PHYSICIAN DID NOT WANT TO COVER THOSE VESSELS WITH THE FLOW DIVERTER. THIS WAS A STRAIGHT SEGMENT OF THE VESSEL, NO CALCIFICATION WAS MENTIONED, IMPLANT WAS DELIVERED WITHOUT DIFFICULTY, FINAL ANGIOGRAPHIC VIEWS AND IMAGES WERE TAKES AS PER PROTOCOL AND THE DOCTOR WAS SATISFIED WITH THE PATIENT OUTCOME. APPROXIMATELY, TWENTY MINUTES FOLLOWING IMPLANTATION, THE PATIENT RETURNED TO THE ANGIO SUITE TO PERFORM A THROMBECTOMY. PROCEDURE COMPLETED AND THE DOCTOR ADDED A 2B3A MEDICATION (EPTIFIBATIDE-INTEGRILIN) VIA AN IV DRIP TO HELP WITH THROMBOSIS. WAS ALERTED 2 HOURS LATER THAT THE PATIENT RETURNED FOR SECOND THROMBECTOMY. PATIENT WAS TAKEN TO THE NEURO ICU.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18361432 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A FLOW DIVERTER IN AN UNRUPTURED ANEURYSM. THE PATIENT RETURNED TO THE ANGIO SUITE TO PERFORM A THROMBECTOMY THREE DAYS AFTER IMPLANT PROCEDURE. THE PROCEDURE WAS COMPLETED, AND PHYSICIAN ADDED A 2B3A MEDICATION (EPTIFIBATIDE-INTEGRILIN) VIA AN IV DRIP TO HELP WITH THROMBOSIS. PATIENT WAS TAKEN TO THE NEURO ICU AND DISCHARGED SEVERAL DAYS LATER.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18352766 ↗
• MalfunctionJul 25, 2022No Flow; No Flow

  IT WAS REPORTED THAT UPON A SIX MONTH FOLLOW-UP ANGIOGRAM POST DEPLOYMENT OF A FLOW DIVERTER, THE DEVICE WAS COMPLETELY OCCLUDED. THE PATIENT IS ASYMPTOMATIC AND THE VESSEL IS BACKFILLING FROM COLLATERALS WITH COMPLETE OBLITERATION OF ANEURYSM. THE PATIENT IS NEUROLOGICALLY INTACT. NO INTERVENTION WILL BE PERFORMED. THE PATIENT INITIALLY PRESENTED WITH A M3 DISSECTING ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100048 ↗