MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number	FRED3021-PMA
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
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 delivery pusher was returned for evaluation.Upon initial investigation of the pusher, it did not appear to be straight.The reported complaint is non-verifiable as the stent wasn't returned to determine if it would get caught.The root cause of this complaint may have been due to tortuous anatomy causing the pusher to become stuck on the stent during removal.It may have also resulted in the pusher not being straight due to the tortuosity.The investigation of the returned pusher found no condition that would have directly resulted in the reported event.
Event or Problem Description
It was reported that treatment was performed for an anterior communicating artery (acom) aneurysm.The origin of the acom complex was reported to be slightly tortuous with some narrowing near the neck of the aneurysm.After placement of the fred between the a2 and a1 segment, the pusher wire caught on the stent during the removal attempt.The intermediate catheter was advanced and used to detach the stent from the pusher wire and microcatheter.After deployment, the fred slightly extended into the internal carotid artery.The stent remains implanted.No additional intervention was performed and there was no patient injury.
Additional Manufacturer Narrative
The stent was not returned for analysis, as it remains implanted.Investigation of the returned delivery pusher revealed the distal marker band was scratched, which may have occurred during retrieval of the pusher from the stent.Fluoroscopic images demonstrate the pusher positioned at approximately 90 degrees to the stent, which may have caused the distal marker band to get caught onto the device; however, without examination of the stent, it cannot be determined if it caused or contributed to the alleged product issue.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10320702
• Report Number: 2032493-2020-00182
• Device Sequence Number: 11491046
• Product Code: OUT
• UDI-Device Identifier: 00842429106631
• UDI-Public: (01)00842429106631(11)190527(17)220430(10)19052753AM
• 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
• 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): 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3021-PMA
• Device Lot Number: 19052753AM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 12/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR