MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; STENT, VASCULAR, INTRACRANIAL

Model Number	FRED3511-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	04/14/2021
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.Investigation is ongoing.
Event or Problem Description
It was reported that a fred 27 3.5 x 17/11 was used to treat a pcom aneurysm.The patient had no significant tortuosity distal or proximal to the aneurysm.The distal measurement was 2.8 mm and proximal was 3.5 mm.The aneurysm was first coiled using a headway duo.The microcatheter was removed to insert the headway 27 to deploy a fred 27.The device was deployed at the terminus utilizing an unsheathing method and landed just distal to the ophthalmic artery.Flow through the device was visualized.The physician wanted to observe the contralateral side and strong flow across the acom was visualized, which warranted more observation on the device side.A dsa injection showed that the fred device was occluded at the proximal portion of the device with no flow distal.Intravenous integrilin was administered and flow was reported to be slow after 15 minutes.Strong flow across the acom filled the affected side and the anterior choroidal and pcom filled, but clot was still observed in the fred device.Patient is on integrilin drip and showed signs of weakness on contralateral side.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies in-stent thrombosis as a potential complication associated with use of the device.

• Brand Name: FRED 27
• Common Device Name: STENT, VASCULAR, INTRACRANIAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11828561
• Report Number: 2032493-2021-00206
• Device Sequence Number: 19944448
• Product Code: OUT
• UDI-Device Identifier: 00842429106662
• UDI-Public: (01)00842429106662(11)200722(17)230630(10)20072255Q
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FRED3511-PMA
• Device Lot Number: 20072255Q
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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