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

Model Number	FRED5019-PMA
Medical Device Problem Codes	Migration (4003); Activation Problem (4042)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fred stent was used for treatment of a posterior communicating artery aneurysm (pcomm artery) measuring - proximal vessel measured 3.77 (ap) and 5.03 (lat) view.Distal vessel measured 4.07 (ap) and 3.74/4.49 (lat) view.Physician stated it was a dysplastic vessel.Patient has (b)(6) and renal insufficiency.3-d spin could not be performed and the patient was not on dat prior to day of procedure.Brilinta 180 mg was administered.At the time of the case, the pru was not known.It came back after the procedure at pru 186.The physician started deployment and only re-sheathed once when the system was on the outer curvature and the device did not appear fully open.Then after fully re-sheathing, continued to un-sheath with more forward pressure on the device wire around the curve, the device opened.Pulled both catheter and device wire off the outer curvature.Last 1/3 device, pushed the device out verses unsheathing.Did not have any statis in the aneurysm.Considered to re-enter the device with a j-wire and to perform a dyna ct scan.The patient could not tolerate a dyna ct due to renal insufficiency.Later in the afternoon symptoms appeared.The cta showed the fred device had clotted off.Patient was taken back to angio suite.Physician tried to open up the fred but could not.The proximal end looked retracted and there was a narrowing.The lower end migrated distally.Patient has left side weakness and aphasia and in rehap.No further intervention is planned.
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 remain implanted in the patient; however, procedure images were provided and their review is not complete.The instructions for use (ifu) identifies migration or misplacement, and stent stenosis as potential complications associated with use of the device.
Additional Manufacturer Narrative
The reported complaint is non-verifiable.The provided images and media were reviewed as part of this investigation.The provided images show a fred5019 device that appears undersized in the proximal genu (proximal landing zone) of ica siphon based on measurements on cta based model.The images also indicate the proximal end of the fred device might be under tension.The combination of inherent tension and inadequate wall apposition in proximal vessel segment might have caused the proximal segment of fred to spring forward/retract.The physical device was not available for this investigation.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13057480
• Report Number: 2032493-2021-00517
• Device Sequence Number: 3950991
• Product Code: OUT
• UDI-Device Identifier: 00842429106839
• UDI-Public: (01)00842429106839(11)210629(17)240531(10)21062954G
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: FRED5019-PMA
• Device Lot Number: 21062954G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: 36 YR
• Patient Sex: Male