• 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 MV-F352427
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphagia/ Odynophagia (1815); Paralysis (1997); Coma (2417); Obstruction/Occlusion (2422); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 08/04/2021
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 device remains impanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed. If additional information is received, microvention, inc. Will issue a supplemental mdr report. The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.
 
Event Description
It was reported that the fred was implanted from the m1 segment of mca to the internal carotid artery (ica) with coils to treat a large dissecting aneurysm in the m1 segment and the procedure was completed without any problems. After the procedure, the patient condition was good; however, five days after the procedure, the patient condition suddenly changed. Ic occlusion from ic to m1 on the ipsilateral side where the fred was implanted was confirmed. Thrombus aspiration was performed; however, the patient was unconscious (vegetative state). As for the efficacy of the medication, the patient was found to be refractory to clopidogrel with the admission examination. Clopidogrel was changed to prasugrel and the procedure was performed after confirming sufficient efficiency with adp34. The physician commented the incident appeared to be due to stent thrombosis in the fred. At the time of the report, the patient has not recovered.
 
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 Key12422680
MDR Text Key269805084
Report Number2032493-2021-00360
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F352427
Device Lot Number20011754Q
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2020
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: 09/03/2021 Patient Sequence Number: 1
-
-