• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27 FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
Model Number FRED3516-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Event Date 05/28/2021
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 implanted in the patient and not returned to the manufacturer for evaluation. Post procedural images were not provided. Therefore, the reported event could not be confirmed. The instructions for use (ifu) identifies thrombus and stroke as potential complications associated with use of the device.
 
Event Description
It was reported that a on (b)(6) 2021 a fred stent was successfully implanted to treat a left vertebral artery aneurysm. On (b)(6) 2021, the patient returned to the hospital with stroke like symptoms. The stent had formed thrombus which was removed with an aspiration catheter. The patient was placed on an integrillin drip overnight.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12292094
MDR Text Key265556383
Report Number2032493-2021-00314
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,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED3516-PMA
Device Lot Number200604524
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 Received09/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
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: 08/08/2021 Patient Sequence Number: 1
-
-