MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-4-10-3D-SS
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Embolus (1830); Ischemia (1942)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The coil will not be returned for evaluation as it was implanted in the patient.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: 2029214-2019-00516, 2029214-2019-00517, 2029214-2019-00518.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that after the coil embolization of an aneurysm, the patient started to exhibit stroke like symptoms.The patient received a head ct, and it was determined that one or more of the coils had protruded from the aneurysm and into the parent vessel.It was stated the coil was implanted in the intended location.The patient's status at the time of the report was alive-with injury.A clot formed on the coil, embolism treated, and patient was recovering.The patient had undergone coil implantation to treat a ruptured, amorphous aneurysm located at the left internal carotid artery, pos terior communicating artery territory with a max diameter of 5.2mm and a neck diameter of 3mm.It was noted the vessel tortuosity was minimal.The devices were prepared as indicated in the ifu.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8669241
• Report Number: 2029214-2019-00516
• Device Sequence Number: 11254720
• Product Code: KRD
• UDI-Device Identifier: 00847536008090
• UDI-Public: 00847536008090
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2021
• Device Model Number: APB-4-10-3D-SS
• Device Lot Number: A687880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR