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

Model Number FRED3516-PMA

Device Problem Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the part/lot number combination could not be performed as the lot number was not available.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that a fred 27 stent was placed in the left internal carotid artery.After placement, the inner part of the stent was noticed to not be completely open, and an endoleak was also observed.The vessel was not open completely and clot started to form.Integrilin flow was restored and the endoleak was corrected through balloon angioplasty and by crossing the stent with microcatheter guidewire.There was no reported patient injury.The patient's condition was reported to be "stable/return to baseline.".

Manufacturer Narrative

Correction: h6 replaced 4117 with 3331 and 4112.D4: 190401572m.H10: provided images and video were reviewed.Img_3541 is of limited quality and it is not possible to clearly discern the inner and outer proximal segments of the stent.Img_ 3545 and img_3546 show the fred stent not opening as intended at its proximal end.Img_ 3549 shows the inner segment of the stent not opening as intended at the proximal end of the stent with a potential thrombus developing proximal to the proximal end of the stent.Img_7937, img_3537, and img_3554 show the fred stent inner segment not opening at the proximal end while the outer part of the stent at the proximal end appears to have opened normally.Img_7491 shows the inner and outer segments of the stent opening normally at the distal end of the stent, but the inner segment of the stent not opening normally at the proximal end of the stent.Img_7938 shows a potential flow deficit in the vessel being treated, but the image is of limited quality.Img_7934 and img_3548 show the treated vessel with normal contrast without indication of the flow deficits.The video, att00002, shows the fred stent not deploying as intended along its length when unsheathed.The images and video confirm the complaint.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.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11646879
• MDR Text Key: 244850265
• Report Number: 2032493-2021-00132
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/11/2021

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: 03/31/2022
• Device Model Number: FRED3516-PMA
• Device Lot Number: 190401572M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/11/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR