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

Model Number	FRED3516-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.
Event or Problem Description
It was reported that the fred was successfully deployed without incident in the left internal carotid artery (ica) to treat a paraophthalmic aneurysm.Post-procedure angiograms identified an anterior internal carotid artery (aica) aneurysm, which was treated with non-microvention devices, and a fistula component of the aica aneurysm was identified.An attempt was made with non-microvention devices to access the vessel associated with the fistula, resulting in contrast extravasation that was treated with onyx liquid embolic.Follow-up angiograms then demonstrated thrombus within the fred stent.Access to the fred was attempted with a wire and a catheter (non-microvention devices) and the fred became "bunched" in the proximal segment.The stent was not able to be accessed to directly treat the thrombus.The patient was on an aggrastat drip.The paraophthalmic aneurysm was accessed and treated with three (3) coils (non-microvention).Final angiograms confirmed good contralateral flow through the anterior communication artery (acom).The patient was shunted due to the posterior bleed.The patient's condition was reported to be "stable.".

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10292581
• Report Number: 2032493-2020-00169
• Device Sequence Number: 19464333
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)200311(17)230228(10)200311544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: FRED3516-PMA
• Device Lot Number: 200311544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR