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

Model Number	FRED5514-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
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 was implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.
Event or Problem Description
It was reported that after deployment of the fred, the stent did not appear to be completely open at the proximal end, which limited flow.A balloon inflation was performed and flow was restored.There was no reported patient injury and the patient is currently reported to be "okay.".
Additional Manufacturer Narrative
Fluoroscopic images were provided.The review of the provided images show a fred device with incomplete expansion and what appears to a filling defect caused by the incomplete opening of the fred at is proximal end.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed with the fred that caused or contributed to the reported complaint.H6 - add component code 515.H6 - add type of investigation code 4112.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11024562
• Report Number: 2032493-2020-00371
• Device Sequence Number: 14339823
• Product Code: OUT
• UDI-Device Identifier: 00842429106853
• UDI-Public: (01)00842429106853(11)200826(17)230731(10)20082655Z
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/02/2021

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: Other
• Device Expiration Date: 07/31/2023
• Device Model Number: FRED5514-PMA
• Device Lot Number: 20082655Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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