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

Model Number FRED5019-PMA

Device Problems Migration (4003); Activation Problem (4042)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/02/2021

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 284210480
• Report Number: 2032493-2021-00517
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106839
• UDI-Public: (01)00842429106839(11)210629(17)240531(10)21062954G
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male