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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 MV-F351127
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Speech Disorder (4415); 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 device migration and thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that a fred stent was implanted in a patient for the treatment of an aneurysm projecting superiorly in internal carotid-paraclinoid. The deployment of the stent was completed smoothly. Since the stent reached the ophthalmic segment, the ophthalmic artery was checked for any abnormality after anesthesia was released. No abnormality was noted and the patient was moved from the operating room. One hour later, aphasia was observed and angiography revealed a thrombus and that the stent became displaced distally. Argatroban and effient were additionally administered and the aphasia improved. Patient was discharged 5 days later maintaining clopidogrel 75 mg and bayaspirin 100 mg medications. Treatment of the thrombus and stent displacement is planned but no date was determined at the time of this report.
 
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Brand NameFRED 27
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 Key11963188
MDR Text Key255107364
Report Number2032493-2021-00220
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMV-F351127
Device Lot Number20042355F
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 Received06/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2020
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: 06/08/2021 Patient Sequence Number: 1
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