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

Model Number	FRED5019-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/14/2020
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 the manufacturing of the device.Three mri angiography images provided demonstrate a saccular aneurysm in the internal carotid artery at c3/c4.One photograph was provided of the fred immediately after removal from the patient.The stent is not expanded from the proximal to the mid segment.Thrombus/blood is visible within the stent.The images provided are consistent with the reported complaint details.The device was returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, and intracerebral bleeding or hemorrhage as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred was used to treat an internal carotid artery (ica) aneurysm.During deployment, the proximal end of the stent would not open; therefore, the fred was removed from the patient.Upon removal, thrombus was identified in the stent and in the m2 segment.Intra-arterial tpa was administered, followed by aspiration thrombectomy, which completely resolved the thrombus.Subsequent mri imaging demonstrated a minor subarachnoid hemorrhage (sah) from the thrombectomy; however, there was no neurological impact to the patient.
Additional Manufacturer Narrative
The stent was returned for evaluation.The delivery system was not returned.Physical evaluation and functional testing of the stent was conducted using sample devices retained for test purposes.The stent was able to be loaded into a microcatheter and fully deployed; however, photographs taken immediately after stent removal confirmed the stent was not open in the mid-section, as reported by the customer.There was no damage or other anomaly identified on the stent that could have caused or contributed to the stent expansion difficulty experienced in the patient and the conditions of use cannot be recreated at bench testing.The root cause could not be determined.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10681270
• Report Number: 2032493-2020-00286
• Device Sequence Number: 14203190
• Product Code: OUT
• UDI-Device Identifier: 00842429106839
• UDI-Public: (01)00842429106839(11)200219(17)230131(10)20021957C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/23/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: FRED5019-PMA
• Device Lot Number: 20021957C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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: 37 YR