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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-F401227
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Cerebral (1889); Rupture (2208); Cerebral Edema (4403)
Event Date 07/13/2020
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 not returned to the manufacturer for evaluation. The root cause of the complaint cannot be determined.
 
Event Description
It was reported that treatment was performed for an aneurysm in the middle cerebral artery (mca). As the distal flare of the fred stent was deployed in the m2, the microcatheter was pulled too much and the stent was pulled down to c1. As the microcatheter was pushed to redeliver the stent to the m2, the stent slid into the aneurysm. After withdrawal of the microcatheter and the fred, subsequent angiography demonstrated a rupture of the aneurysm. A balloon catheter was delivered across the aneurysm neck to stop blood flow to the aneurysm. Approximately fifteen (15) coils were placed in the aneurysm and hemostasis was achieved. Another fred was then placed at the aneurysm as originally planned. Heparin was not reversed. There appears to be no damage to the brain stem. The patient was reported to be in serious condition, but is recovering.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key10396973
MDR Text Key202578407
Report Number2032493-2020-00198
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F401227
Device Lot Number20021151C
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 Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
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: 08/12/2020 Patient Sequence Number: 1
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