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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 Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)
Event Date 08/05/2020
Event Type  Death  
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 not returned to the manufacturer for evaluation and the alleged product issue could not be confirmed. The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, bleeding or hemorrhage including intracerebral, and neurologic deficits including stroke and/or death as potential complications associated with use of the device.
 
Event Description
It was reported that treatment was performed for an unruptured right internal carotid artery (ica) terminus aneurysm. The fred device was placed in the ica to the origin of the a1 segment, across the middle cerebral artery (mca). Upon completion of the procedure, it appeared that the mca territory was not filling. Thrombus was identified in the blood vessel. Integrilin was administered immediately, which restored flow within 15-20 minutes. In several hours after the procedure, an intracerebral hemorrhage (ich) was identified in the left hemisphere, which was on the contralateral side from the implanted device. The patient died the next day on (b)(6) 2020 from a cerebral hematoma on the contra-lateral side. The death was reported to be related to the integrilin treatment. No device malfunction or information suggesting that the device may have caused or contributed to the adverse event and patient death was reported to the manufacturer.
 
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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 Key10497723
MDR Text Key205872480
Report Number2032493-2020-00238
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 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED3507-PMA
Device Lot Number20050755H
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 Received08/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2020
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: 09/04/2020 Patient Sequence Number: 1
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