Stent FRED3009-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842429106617), received between Oct 9, 2020 and Nov 3, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Activation Problem” (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 3, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE FRED STENT IMPLANTATION PROCEDURE, THE DEVICE DID NOT FULLY OPEN IN THE MIDDLE AND PROXIMAL SECTIONS. THE PHYSICIAN STATED THAT LARGE THROMBUS BURDEN PRESENTED POST DEPLOYMENT OF THE FRED DEVICE. A BALLOON WAS USED TO POST-DILATE THE DEVICE AND DRUGS WERE ADMINISTERED. REPORTEDLY, THE THROMBUS RESOLVED AFTER SOME TIME AND NO ISSUES OR DEFICITS WERE SEEN IN PATIENT, WHO WAS STABLE POST PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12746193 ↗
• InjuryJun 30, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER SUCCESSFULLY IMPLANTING THE FRED 21 STENT IN THE M1 SEGMENT OF MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, THE PATIENT CAME BACK 6 DAYS POST IMPLANTATION WITH A STROKE. ANGIOGRAM RUN SHOWED THE STENT MIGRATED DOWN THE M1 VESSEL BLOCKING THE BIFURCATION. INTERVENTION WAS TAKEN AND THE PATIENT WAS TREATED WITH DIRECT CATHETER INTEGRILIN AND DRIP.

  Patient problems: Ischemia Stroke

  MAUDE report 12097221 ↗
• InjuryMar 19, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A FRED STENT TO TREAT A RECURRENT ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY M1 SEGMENT, IT WAS NOTICED THAT THE DISTAL STRUTS OF THE STENT WERE NOT FULLY APPOSED TO THE VESSEL WALL AND A SMALL AMOUNT OF NON-OCCLUSIVE THROMBUS HAD FORMED BETWEEN THE STRUTS AND THE VESSEL WALL. THIS THROMBUS WAS LYSED WITH INTRAVENOUS ADMINISTRATION OF INTEGRILIN AND BETTER WALL APPOSITION OF THE STRUTS WAS ACHIEVED BY PERFORMING BALLOON ANGIOPLASTY OF THE FRED DEVICE. THE PATIENT WOKE UP FROM ANESTHESIA NEUROLOGICALLY INTACT, AND REMAINS INTACT FOUR MONTHS AFTER THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11522327 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX DAYS AFTER SUCCESSFUL IMPLANTATION OF THE FRED IN THE RIGHT A1/A2 SEGMENT TO TREAT A VERY SMALL RUPTURED ACOM ANEURYSM, AN OCCLUSION OF THE FRED WAS IDENTIFIED; HOWEVER, THERE WAS COLLATERAL FLOW AND THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED DEVICE MALFUNCTION.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11160296 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIRTY MINUTES AFTER THE FRED JR. WAS IMPLANTED, THE PATIENT HAD APHASIA AND ANGIOGRAPHY DEMONSTRATED IN-STENT THROMBOSIS. INTEGRILIN IA AND IV WAS DELIVERED TO THE PATIENT, AS WELL AS TPA. THERE WAS NO ALLEGED DEVICE MALFUNCTION. THERE WAS NO REPORTED SEQUELA. THE PATIENT IS CURRENTLY REPORTED TO BE DOING "OKAY."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10659764 ↗