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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 Problems Loss of Vision (2139); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 05/06/2021
Event Type  Injury  
Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for analysis. Post procedural images were not provided; therefore the reported event could not be confirmed. 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 instructions for use (ifu) identifies hemiplegia, ischemic stroke and stent thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that a fred jr. Stent was implanted to treat an aneurysm of the fetal posterior cerebral artery. The stent was deployed without issue and stasis was observed to be forming inside of the aneurysm. Four hours post procedure, thrombus was observed to be forming inside of the stent. Balloon angioplasty was performed, which restored flow, but the stent continued to form thrombus. It was the physician's belief that the clot formation inside the aneurysmal sac was so severe that it went down into the fred jr. A follow-up the next day showed re-profusion, but the patient had already had a stroke and they were blind on right side. Integrilin was administered.
 
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Brand NameFRED 21
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
7142478000
MDR Report Key11943493
MDR Text Key254511792
Report Number2032493-2021-00219
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 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED2513-PMA
Device Lot Number201007563
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 Received05/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2020
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: 06/04/2021 Patient Sequence Number: 1
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