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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, EMBOLIZATION, VASCULAR
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MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number QC-22-50-3D
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The coil has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-00911, 2029214-2019-00912.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received areport that an axium coil unintentionally detached.
 
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Brand Name
AXIUM 3D
Common Device Name
DEVICE, EMBOLIZATION, VASCULAR
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key8992821
Report Number2029214-2019-00911
Device Sequence Number3288076
Product Code KRD
UDI-Device Identifier00836462010536
UDI-Public00836462010536
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K081465
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date12/01/2019
Device Model NumberQC-22-50-3D
Device Lot NumberA382977
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/16/2019
Initial Report FDA Received Date09/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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