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

Model Number FREDJR2513

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

Patient Problems Aneurysm (1708); Thrombosis/Thrombus (4440)

Event Date 10/27/2021

Event Type  Injury  

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 remains implanted in the patient and not available for analysis; therefore, the alleged product issue cannot be confirmed. If additional information is received, microvention, inc. , will issue a supplemental mdr report.

Event Description

As reported through a (b)(6) study, the patient was treated for a remnant aneurysm, located on the right anterior cerebral artery (aca), previously ruptured on (b)(6) 2018 and previously treated with (b)(4) in the right aca. The treatment consisted of using a (b)(4). The fred has been expanded and covered the neck. During the procedure tirofiban, heparin and abciximab (reopro) had been prescribed. Procedure with complication was reported as follows: on (b)(6) 2021, a per-procedural complication was reported - ae1, occlusion of right anterior cerebral artery after fred deployment. According to the description provided by the site, the event was serious and not associated with malfunction of the (b)(4) device. In term of clinical impact, patient is asymptomatic with severe seriousness. This event is related to the study device and the procedure. Drug treatment, (aggrastat injection and actlis in situ) was taken in its regards and the outcome is resolved without sequelae on (b)(6) 2021. On (b)(6) 2021, the patient was discharged from the hospital with mrs score 0. Antiplatelet treatment: 160 mg: asa (aspirin) start date (b)(6) 2021 and end date: ongoing 180 mg: ticagrelor (brillique) start date: (b)(6) 2021 and end date: ongoing antiplatelet resistance was not tested. Other treatment: abcixmas: start date: (b)(6) 2021 and end date: (b)(6) 2021 agrastat: start date: (b)(6) 2021 and end date: (b)(6) 2021.

• Brand Name: FRED JR.
• 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: 12930258
• MDR Text Key: 286953422
• Report Number: 2032493-2021-00473
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: FREDJR2513
• Device Lot Number: 210715527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/03/2021 Patient Sequence Number: 1