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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 4.0X18X12 FLOW DIVERTER

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MICROVENTION, INC. FRED 4.0X18X12 FLOW DIVERTER Back to Search Results
Model Number FRED4012-A
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  malfunction  
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 returned to the manufacturer for analysis. The investigation is underway.
 
Event Description
It was reported that an attempt was made to implant the stent in the internal carotid artery. After one-third of the stent had been deployed from the microcatheter at the c7 segment, the stent became stuck in the microcatheter and it could not be resheathed. The guide catheter was advanced up to the c7 segment and captured the open stent. The stent was removed from the patient. There was no reported patient injury. The patient's current condition is reported to be "great. ".
 
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Brand NameFRED 4.0X18X12
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 Key10439423
MDR Text Key204017460
Report Number2032493-2020-00219
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED4012-A
Device Lot Number191127559
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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