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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-F451327
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Speech Disorder (4415); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
A search for non-conformance 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 analysis. Post procedural images were not provided; therefore the reported event could not be confirmed. The instructions for use (ifu) identifies in-stent thrombosis, stroke or tia (transient ischemic attack), migration or misplacement as potential complications associated with use of the device.
 
Event Description
It was reported that after the fred stent was implanted for the treatment of a cerebral aneurysm, the patient developed cerebral infarction that caused aphasia and paralysis at the icu within one hour. After emergency ct, the patient underwent mechanical thrombectomy. Angiography revealed that the stent implanted proximal to the p-com had moved to the distal side with the flare straddling the anterior cerebral artery (aca) and middle cerebral artery (mca). A thrombus was shown from around the origin of the mca to around the ic-top. Argatroban was administered from the microcatheter via intra-arterial injection, which achieved recanalization. Immediately after the catheter procedure, the patient became able to speak and recovered to a degree where slight paralysis remained. The patient was transferred to the icu and was gradually recovering from paralysis with the passage of time and was progressing favorably.
 
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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 Key12308922
MDR Text Key266074234
Report Number2032493-2021-00319
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F451327
Device Lot Number20102856U
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2020
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: 08/11/2021 Patient Sequence Number: 1
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