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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
Model Number FRED3507-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Event Date 07/17/2020
Event Type  Injury  
Manufacturer Narrative
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. The device was implanted in the patient and thus not returned to the manufacturer for evaluation. The root cause of the complaint cannot be determined. The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, and neurologic deficits including stoke as potential complications associated with use of the device.
 
Event Description
It was reported that elective treatment was performed for an internal carotid artery (ica) aneurysm. The patient was on dapt (aspirin and brilinta). Deployment of the fred went well and the patient did well during the procedure. 48 hours post-procedure, the patient had a stroke with severe hand weakness and mild arm weakness on the left. An angiogram was performed, which demonstrated an occlusion within the fred. Integrilin and tpa were delivered intra-arterially without effect; however, angiography showed there was good flow across the acom, filling the mca territory, so mechanical thrombectomy inside the stent was not attempted. The stent remains completely occluded. The patient has had slow improvement of the stroke symptoms, but there are still remaining deficits that are anticipated to get better over weeks with rehab and time.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key10411670
MDR Text Key203092098
Report Number2032493-2020-00210
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED3507-PMA
Device Lot Number19051355WM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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: 08/14/2020 Patient Sequence Number: 1
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