MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4007-PMA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Headache (1880)
Date of Event	10/16/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12824424
• Report Number: 2032493-2021-00443
• Device Sequence Number: 1377589
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)190520(17)230630(10)20072255Y
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FRED4007-PMA
• Device Lot Number: 20072255Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 78 KG