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

Model Number MV-F451827

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/21/2022

Event Type  Injury  

Event Description

It was reported that during treatment of a cerebral aneurysm, the fred flow diverter stent was implanted and although the deployment of the stent appeared to have no problems, angiography taken immediately afterward revealed decreased blood flow to the anterior cerebral artery (aca).Closer examination confirmed an in-stent thrombus on the distal side of the stent.The stent was started to be deployed from m1 and after the stent was positioned so that only the flare part covered the aca using a jail technique, the stent was deployed.Angiography showed a suspected decrease in blood flow on the aca side and detailed imaging revealed a thrombus-like around the distal flare on the aca side.Concerned about insufficient stent apposition on the distal side, ozagrel and urokinase were administered and effent was then added while percutaneous old balloon angioplasty (poba) was performing on the m1 side and the a1 side through the flare.The thrombus did not completely disappear by poba and it was suspected that a thrombus might have occurred in the stent.The stent was therefore attempted to be removed using a snare device, but the stent could not be removed in one attempt.However, angiography showed that the thrombus disappeared and blood flow in the aca recovered.Angiography was repeated every 5 minutes and confirmed that there was no change in the condition.The procedure was ended without removing the stent.Due to the attempt to remove the stent, the distal flare was broken and located on the proximal side of the stent on fluoroscopy.The patient recovered and is being followed up on.

Manufacturer Narrative

The lot number was not provided; therefore, a search for device history record (dhr) could not be performed.The device remain implanted in the patient and not available for return to the manufacturer and procedure images were not provided.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.

Manufacturer Narrative

Additional information received indicating no addition treatment is planned at this point.Current patient condition described as "patient is doing well.Angiographic follow-up had not been done yet.Mra showed that blood flow to the aneurysm still remains." physician will decide whether additional treatment if needed if aneurysm does not resolve at 12-month follow-up.Review of set of images provided by physician: there are two right ica aneurysms: a 5x7.5 mm ophthalmic with an approximately 4 mm neck, and a small, about 2.5 mm wide-necked pcom.Three parent artery measurements are seen: 3.58 mm just distal to pcom aneurysm, 4.9 mm in the mid cavernous ica, and 3.76 mm in the posterior ica siphon.Subsequent images show the fred being deployed through a headway 27 from the ica terminus (finished ends) to the posterior ica siphon; the braided portion of the fred is in the distal ica and not in the terminus itself.Later, clot is seen in the distal aspect of the stent (more on a1 side) and there is marked slow flow in the aca with only the a1 segment visualized.Then a guidewire microballoon catheter combination is seen through the stent to the m1 mca, and then to the a2 segment of the aca, with flow reestablished in aca and decrease in the amount of clot.Later, there is recurrence of clot in the distal stent again mostly on the a1 side.Balloon angioplasty is again performed through m1 and a1, with minimal change in the clot.There also appears to be new clot in the proximal part of the stent.There are then images showing the unsuccessful attempt at removing the fred with a solitaire 6x40 mm.A final completion ap right ica angiogram shows the stent opened with no clot.Still unsubtracted lateral and oblique radiographs show that one of the distal fred radiopaque markers is now located in the distal aspect of the braided portion of the fred, as described in the complaint; this is presumably damage caused by the removal attempt.Post-op day 1 dwi mr axial images show no evidence of ischemic hits.Post-op day 3 ap oblique right ica subtracted dsa shows normal flow through the stent and no clot.The cause for the clot formation is not seen on the images provided.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: 13904704
• MDR Text Key: 287920912
• Report Number: 2032493-2022-00107
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-F451827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female