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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED) SYSTEM; INTRACRANIAL ANEURYSM FLOW DIVERTER
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MICROVENTION INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED) SYSTEM; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FRED4007
Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Positioning Problem (3009)
Patient Problem Ruptured Aneurysm (4436)
Event Date 03/10/2021
Event Type  Injury  
Event Description
Patient came in for elective flow diverting stent placement.The device was placed appropriately across the 2 aneurysms.After removal of all microcatheters, a global angiogram was obtained.During this angiogram, the device migrated, and caused slow flow in the middle cerebral artery (mca) territory.Subsequent attempts to reposition or recapture the device were unsuccessful and resulted in rupture of 1 of the 2 aneurysms, and the device occluded flow into the mca.Concern that the fred device must be oversized in diameter and length for safe use or the chart for the sizing of the device must be validated/corrected and made more accurate.
 
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Brand Name
FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED) SYSTEM
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICROVENTION INC.
1311 valencia avenue
tustin CA 92780
MDR Report Key11607341
MDR Text Key243563440
Report Number11607341
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/11/2021,03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFRED4007
Device Lot Number20072255Z
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2021
Event Location Hospital
Date Report to Manufacturer04/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age18250 DA
Patient Weight60
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