• 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 JR. 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 JR. FLOW DIVERTER Back to Search Results
Model Number FREDJR2520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Paralysis (1997); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 11/24/2021
Event Type  Injury  
Event Description
It was reported that a fred jr. Stent was implanted to treat an aneurysm of the left mca. After the procedure, in-stent thrombosis formed. A thrombectomy was performed and the stent was removed. The patient experienced a stroke (nihss score: 20) on the ipsilateral side and has permanent damage. Following stent removal, angiography showed arterial unclogging but with the presence of multiple distal occlusions. The patient was hospitalized. Their clinical status was stable with aphasia, deviation and right-side hemiplegia.
 
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 was not returned to the manufacturer for evaluation. Procedural or post procedural images were not provided; therefore the reported event could not be confirmed. The instructions for use (ifu) identifies in-stent thrombosis as a potential complication associated with use of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFRED JR.
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 Key13056755
MDR Text Key284209494
Report Number2032493-2021-00509
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 11/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFREDJR2520
Device Lot Number210113521
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2021
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: 12/21/2021 Patient Sequence Number: 1
-
-