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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 FRED3516-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)
Event Date 02/10/2021
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided; therefore, a search for production-related ncrs could not be performed. The device was implanted in the patient and not returned to the manufacturer for analysis. Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed. The instructions for use identifies rupture or perforation of the aneurysm as potential complications associated with use of the device.
 
Event Description
It was reported that a fred stent was implanted to treat an aneurysm of the left internal carotid artery (ica). Six days post-procedure, the aneurysm ruptured. Coil embolization was performed on the ruptured aneurysm. There was no reported device malfunction. The patient's current condition is unknown.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11478121
MDR Text Key239677461
Report Number2032493-2021-00070
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED3516-A
Device Lot Number20031452A
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 Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2020
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: 03/12/2021 Patient Sequence Number: 1
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