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

Model Number	FRED3536-PMA
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	08/06/2020
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 cannot be determined.The instructions for use (ifu) identifies vessel stenosis or thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred was used as treatment for a tortuous m2 to m1 fusiform aneurysm with two curves.The fred was delivered smoothly; however, the proximal stent did not completely open upon deployment.Thrombus formation was observed inside the proximal portion of the fred.Integrilin was administered through the microcatheter at the proximal portion of the device.Aspiration was attempted, but was not successful.After multiple manipulations of the device with the microcatheter and microwire, the fred completely opened and the thrombus within the device was no longer visualized.No neurological deficits or abnormalities were observed during the post-procedure neurological exam of the patient.The patient is currently reported to be doing well.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10495426
• Report Number: 2032493-2020-00241
• Device Sequence Number: 2344402
• Product Code: OUT
• UDI-Device Identifier: 00842429106693
• UDI-Public: (01)00842429106693(11)190513(17)220430(10)190513558M
• 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): 08/06/2020

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: 04/30/2022
• Device Model Number: FRED3536-PMA
• Device Lot Number: 190513558M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/04/2020
• 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