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	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 stent was returned without the delivery system.The reported complaint could not be confirmed, as the stent was received with significant damage that precluded the possibility of functional testing to test deployment.The observed damage is consistent with the device being subject to forces above specification, likely during the retrieval with a snare as stated in the reported complaint.
Event or Problem Description
It was reported that after deployment of the fred, the middle of the stent did not completely open around a curve in the vessel.The stent was retrieved from the patient with a snare.There was no reported patient injury.The patient is currently reported to be "fine.
Additional Manufacturer Narrative
During review of an article titled, " microsnare retrieval of a distorted flow re-direction endoluminal device (fred)", a complaint was identified and linked to this previously reported event.A supplemental report is being filed to provide additional information found in the article.The fred was attempted to be implanted to treat am internal carotid artery (ica) aneurysm.The device was deployed with the distal anchors in the distal left ica with adequate coverage of the left clinoidal aneurysm.After deployment, it was noticed that the device foreshortened and was not providing adequate coverage across the neck of the aneurysm.The decision was made to place another fred to completely cover the aneurysm.Again, the headway-27 microcatheter along with a synchro-2 microwire was navigated into the left cavernous ica.At this time, it was noticed the microwire was unable to navigate beyond the proximal segment of the device.Further, inspection revealed the fred did not completely open and, instead, appeared to be distorted in the left cavernous ica.The device was successfully retrieved with the snare and pulled into the guide sheath.This process was repeated twice due to the dislodgement of the device from the snare during retrieval.The patient was closely monitored in the neurocritical care unit overnight and was discharged home in post-procedure day two with reported improvement in her headaches and neurologically intact condition.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10659798
• Report Number: 2032493-2020-00280
• Device Sequence Number: 3145895
• Product Code: OUT
• UDI-Device Identifier: 00842429106853
• UDI-Public: (01)00842429106853(11)200323(17)230228(10)20032356B
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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: 02/28/2023
• Device Model Number: FRED5514-PMA
• Device Lot Number: 20032356B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female