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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

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MICROVENTION, INC. FRED 21; FLOW DIVERTER Back to Search Results
Model Number FRED2513-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/19/2020
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 not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the alleged event cannot be confirmed.The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.
 
Event Description
It was reported that after deployment of the fred device in the posterior cerebral artery (pca), blood flow was reduced in the distal pac and integrilin was administered.Efforts were made to retrieve the fred from the patient, but they were unsuccessful and the device remains implanted.The patient is currently reported to be "ok" and is recovering.
 
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Brand Name
FRED 21
Type of Device
FLOW 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 Key11042507
MDR Text Key222621727
Report Number2032493-2020-00377
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00842429106587
UDI-Public(01)00842429106587(11)200527(17)230430(10)20052755L
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 Physician
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/30/2023
Device Model NumberFRED2513-PMA
Device Lot Number20052755L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/19/2020
Initial Date FDA Received12/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight50
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