Stent FRED5019-PMARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00842429106839), received between Sep 24, 2020 and Dec 21, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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. How this data works · Data updated Oct 13, 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 · 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.

• InjuryDec 21, 2021Migration; Activation Problem; Migration; Activation Problem

  IT WAS REPORTED THAT THE FRED STENT WAS USED FOR TREATMENT OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM (PCOMM ARTERY) MEASURING - PROXIMAL VESSEL MEASURED 3.77 (AP) AND 5.03 (LAT) VIEW. DISTAL VESSEL MEASURED 4.07 (AP) AND 3.74/4.49 (LAT) VIEW. PHYSICIAN STATED IT WAS A DYSPLASTIC VESSEL. PATIENT HAS (B)(6) AND RENAL INSUFFICIENCY. 3-D SPIN COULD NOT BE PERFORMED AND THE PATIENT WAS NOT ON DAT PRIOR TO DAY OF PROCEDURE. BRILINTA 180 MG WAS ADMINISTERED. AT THE TIME OF THE CASE, THE PRU WAS NOT KNOWN. IT CAME BACK AFTER THE PROCEDURE AT PRU 186. THE PHYSICIAN STARTED DEPLOYMENT AND ONLY RE-SHEATHED ONCE WHEN THE SYSTEM WAS ON THE OUTER CURVATURE AND THE DEVICE DID NOT APPEAR FULLY OPEN. THEN AFTER FULLY RE-SHEATHING, CONTINUED TO UN-SHEATH WITH MORE FORWARD PRESSURE ON THE DEVICE WIRE AROUND THE CURVE, THE DEVICE OPENED. PULLED BOTH CATHETER AND DEVICE WIRE OFF THE OUTER CURVATURE. LAST 1/3 DEVICE, PUSHED THE DEVICE OUT VERSES UNSHEATHING. DID NOT HAVE ANY STATIS IN THE ANEURYSM. CONSIDERED TO RE-ENTER THE DEVICE WITH A J-WIRE AND TO PERFORM A DYNA CT SCAN. THE PATIENT COULD NOT TOLERATE A DYNA CT DUE TO RENAL INSUFFICIENCY. LATER IN THE AFTERNOON SYMPTOMS APPEARED. THE CTA SHOWED

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13057480 ↗
• InjuryOct 14, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE FRED WAS USED TO TREAT AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. DURING DEPLOYMENT, THE PROXIMAL END OF THE STENT WOULD NOT OPEN; THEREFORE, THE FRED WAS REMOVED FROM THE PATIENT. UPON REMOVAL, THROMBUS WAS IDENTIFIED IN THE STENT AND IN THE M2 SEGMENT. INTRA-ARTERIAL TPA WAS ADMINISTERED, FOLLOWED BY ASPIRATION THROMBECTOMY, WHICH COMPLETELY RESOLVED THE THROMBUS. SUBSEQUENT MRI IMAGING DEMONSTRATED A MINOR SUBARACHNOID HEMORRHAGE (SAH) FROM THE THROMBECTOMY; HOWEVER, THERE WAS NO NEUROLOGICAL IMPACT TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10681270 ↗
• InjurySep 24, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT AFTER THE FRED WAS DEPLOYED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), POST-PROCEDURE IMAGING DEMONSTRATED A WIDELY PATENT STENT WITH GOOD FILLING OF THE MCA AND ACA TERRITORIES. FIVE DAYS POST-PROCEDURE, THE PATIENT WAS READMITTED WITH NEUROLOGICAL CHANGES AND IMAGING CONFIRMED A TOTAL THROMBOTIC OCCLUSION OF THE FRED AND THE ICA, AS WELL AS NARROWING OF THE PROXIMAL FRED. THE PROXIMAL FRED WAS FULLY EXPANDED WITH A BALLOON AND A STENT WAS IMPLANTED IN THE ICA, WHICH INCREASED FLOW INTO THE MCA. AN MRI PERFORMED THE NEXT DAY DEMONSTRATED AN MCA TERRITORY INFARCT. THE PATIENT WAS STILL HOSPITALIZED AT THE TIME OF THIS REPORT.

  Patient problems: Ischemia; Thrombosis/Thrombus

  MAUDE report 10582067 ↗