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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 FRED5009-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/05/2020
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 was implanted in the patient and not returned to the manufacturer for evaluation. Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed. The instructions for use identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device. This device was used during the same procedure as the device referenced in mfr. Report # 2032493-2020-00359.
 
Event Description
It was reported that during treatment of a right superior hypophyseal artery aneurysm, two fred stents were deployed with good wall apposition in the right internal carotid artery (rica); however, the rica became occluded shortly after implantation. Integrilin was administered and a balloon inflation was performed within the stents, which completely recanalized the rica and fully restored blood flow. The patient was neurologically intact and discharged from the hospital the following day.
 
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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
aliso viejo, CA 92656
MDR Report Key10953625
MDR Text Key219905252
Report Number2032493-2020-00360
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 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED5009-PMA
Device Lot Number20073057Q
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 Received11/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2020
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: 12/05/2020 Patient Sequence Number: 1
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