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Model Number UNKNOWN
Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418)
Event Type  Injury  
Manufacturer Narrative
The lot numbers were not provided; therefore, a search for production-related ncrs could not be performed. The devices were implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issues cannot be confirmed. The instructions for use (ifu) identifies thrombosis and stroke as potential complications associated with use of the device.
Event Description
As reported through the article titled, "flow redirection endoluminal device (fred) with or without adjunctive coiling in treatment of very large and giant cerebral aneurysms," published in clinical neuroradiology and reviewed by company on august 20, 2021: post aneurysm treatment with a fred device, two patient's developed in-stent stenosis requiring balloon angioplasty. Additionally, during follow-up, two other patients developed ischemic complications. The first in-stent stenosis, involved an 8 × 5 × 67mm fusiform right vertebrobasilar aneurysm, treated with 3 fred stents telescopically. There was torsion at the second fred, where balloon dilatation was performed. The second in-stent stenosis case involved a saccular left paraophthalmic aneurysm measuring 28 × 21 × 19mm. The stent was not fully opened at the proximal part which required subsequent balloon angioplasty. In regards to the early (>1 month) ischemic complication, it occurred in a patient with fusiform right vertebrobasilar artery aneurysm had transient symptoms (vertigo, swallowing disorder) due to minor stroke related to involvement of perforating branches most probably due to atherosclerotic background. The late (> 1 month) ischemic complication involved a patient with a paraophthalmic ica aneurysm that had been treated with a fred and adjunctive coiling. The patient had a minor stroke due to complete occlusion of the parent artery. ".
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Brand NameFRED
Manufacturer (Section D)
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key12492512
MDR Text Key272669374
Report Number2032493-2021-00381
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/17/2021 Patient Sequence Number: 1