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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR AXIUM PRIME BRPL HLX; DEVICE, EMBOLIZATION, VASCULAR
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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR AXIUM PRIME BRPL HLX; DEVICE, EMBOLIZATION, VASCULAR Back to Search Results
Model Number APB-3-6-HX-ES
Date of Event 12/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Medtronic received information that the implant coil could not be detached with an instant detacher so another instant detacher was used on the same coil, but it still would not detach.The implant coil was removed from the patient.The procedure was successfully completed with another device.No patient injury was reported as a result of the event.The patient¿s vessel tortuosity and vessel diameter was unknown.Ancillary device: st10 str.
 
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Brand Name
AXIUM PRIME BRPL HLX
Common Device Name
DEVICE, EMBOLIZATION, VASCULAR
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
MDR Report Key8213750
Report Number2029214-2019-00001
Device Sequence Number2792168
Product Code KRD
UDI-Device Identifier00847536021082
UDI-Public00847536021082
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K151447
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/03/2019
1 Device 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 Date03/07/2021
Device Model NumberAPB-3-6-HX-ES
Device Catalogue NumberAPB-3-6-HX-ES
Device Lot NumberA610054
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/12/2018
Initial Report FDA Received Date01/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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