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Model Number FRED4007-PMA
Device Problem Migration (4003)
Patient Problems Aneurysm (1708); Headache (1880)
Event Date 10/16/2021
Event Type  Injury  
Event Description
It was reported that the patient presented with an unruptured right parclinoid ica aneurysm. A fred flow diversion stent was selected and placed successfully across the neck of the aneurysm with good wall apposition and positioning of the stent. 12 days post implantation, the patient returned complaining of headache. Ct angiogram demonstrated migration of the fred stent into the middle cerebral artery. Diagnostic intervention was performed 4 days later that confirmed the stent migrated to the distal m1 segment of the middle cerebral artery. The right paraclinoid ica aneurysm is patent, but it remains. There was no evidence of intracranial hypertension. Per the physician, the patient was discharged and doing "good. " the patient has baseline left side deficit. The physician wants the fred to endotheliaze for 6 months and then will treat with a pipeline.
Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. The device remains implanted in the patient and not available for analysis; however, procedure images were provided. The images on the day of the implant ((b)(6) 2021) show the supraclinoid ica measured at 4. 0 mm proximal and distal to the posterior wall small, shallow aneurysm. At the level of the aneurysm, the artery is likely larger than 4 mm. Post implant, fred is in a good position. A 4 mm x 7/13 fred was implanted. Images obtained on (b)(6) 2021 show that the fred has migrated to the distal supraclinoid ica and proximal mca, and is not covering the aneurysm anymore. No thrombus seen. According to other recent similar cases, the fred, in this case, was undersized and this caused its migration. Mv has determined that, in straight, cylindrical arteries where the proximal and distal diameters are similar or close to similar, it is advisable to oversize the device by 0. 5 mm; for example, if the artery measures just under 4, 4, or slightly over 4 mm, the outward force of a 4 mm fred is likely insufficient to ensure stable anchoring and/or wall apposition. The instructions for use (ifu) identifies headache and device migration as a potential complication associated with use of the device.
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Brand NameFRED 27
Manufacturer (Section D)
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key12824424
MDR Text Key284480229
Report Number2032493-2021-00443
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED4007-PMA
Device Lot Number20072255Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2020
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: 11/16/2021 Patient Sequence Number: 1