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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 5.0X21X14 FLOW DIVERTER

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MICROVENTION, INC. FRED 5.0X21X14 FLOW DIVERTER Back to Search Results
Model Number FRED5014-A
Device Problems Difficult to Remove (1528); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/21/2020
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 received by the manufacturer for evaluation. Upon initial examination, the stent was observed to be damaged. Since the stent was damaged, it was not possible to reload the stent to determine if the proximal end was able to open during deployment. The investigation of the returned fred found the implant to be severely damaged. The damage is consistent with the use of the snare device described in the complaint. Due to the damage, it cannot be determined if the proximal end was able to open during deployment.
 
Event Description
It was reported that during deployment, the proximal end of the flow diverter would not open; however, the stent was released in the vessel. A guide wire was passed through the stent, but the attempt to expand it was unsuccessful. The stent was removed from the patient with a snare device. There was no reported patient injury. The patient's current condition was reported to be "fine. ".
 
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Brand NameFRED 5.0X21X14
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 Key10439633
MDR Text Key203985065
Report Number2032493-2020-00221
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
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
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED5014-A
Device Lot Number20011654A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
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: 08/21/2020 Patient Sequence Number: 1
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