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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 FRED4528-PMA
Device Problems Separation Failure (2547); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative
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 stent was returned without the original pusher. However, the stent was able to fully open and detach from a new pusher wire during the investigation. The damage to the tantalum wire is consistent with the stent being retrieved with a snare. The non-returned pusher is a critical component for this investigation; without the return and physical evaluation of the pusher, the complaint is considered non-verifiable.
 
Event Description
It was reported that a flow diverter device (fred 27 stent) used for treatment of a paraclinoid aneurysm would not release from the delivery pusher wire. The flared ends of the stent were open just enough to be loose from the pusher wire but the stent would not open fully. A snare was used to removed the device without any issue and the case was ended without treatment of the aneurysm. The patient suffered no consequences due to the procedure or post procedure and was discharged the next day.
 
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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 Key11971327
MDR Text Key256278168
Report Number2032493-2021-00222
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 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED4528-PMA
Device Lot Number19120953HM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
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: 06/09/2021 Patient Sequence Number: 1
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