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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED JR. FLOW DIVERTER Back to Search Results
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.
 
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Brand NameFRED JR.
Type of DeviceFLOW 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 Key12930258
MDR Text Key286953422
Report Number2032493-2021-00473
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P180027
Number of Events Reported1
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 Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFREDJR2513
Device Lot Number210715527
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2021
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
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