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

Model Number	APB-4-12-HX-SS
Medical Device Problem Codes	Stretched (1601); Migration (4003)
Health Effect - Clinical Codes	Encephalopathy (1833); Hemorrhage, Subarachnoid (1893); Muscle Weakness/Atrophy (1967); Dysphasia (2195); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil migrated, became stuck on the pipeline and stretched resulting in the coil being left in the patient.The patient was undergoing surgery for treatment of a recurrent saccular, ruptured aneurysm of the left, posterior communicating (pcom) artery with a max diameter of 8mm and a 4mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.It was reported that the plan in the case was to lay a second layer of pipeline in the internal carotid artery and then approach the aneurysm from the posterior flow and coil the recan and coil occlude the posterior communicating (pcom) artery.The pipeline deployment went without issue.The microcatheter was able to be delivered and placed just outside of the aneurysm.The axium soft coil was delivered, and it was thought the coil should have been protected from entering the ica by the double pipelines.The axium coil seemed to fill the aneurysm, but then migrated past the pipeline and into the middle cerebral artery (mca).It was noted no real force was required.Dyna ct appeared to show the coil went through the pipeline, and was floating within the stent and out into the mca.It was decided to remove the coil; however, the coil became stuck on the pipeline, and then stretching from point of contact with the pipeline into basilar.A third layer of pipeline was used to jail the coil in the mca, and the physician was able to drag the coil into the ica using a pipeline, so ultimately, the pipeline was not jailing the anterior communicating (acom) artery.The physician attempted to retrieve the coil over the sl-10 microcatheter, which led to dissection in vert which also had to be piped.Only some of the product was able to be removed, and the remainder stayed in the patient.It was stated a continuous flush had been administered during the procedure, and the coil had not been repositioned.Post-procedure angiographic results looked acceptable.The patient was not doing well the morning of (b)(6) 2020: there was global aphasia, weakness on left side, mri showed subarachnoid hemorrhage or contrast.It was thought the patient had a contrast induced encephalopathy.Ancillary devices include a neuron max, phenom plus, benchmark guide catheter, sl-10.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10486439
• Report Number: 2029214-2020-00883
• Device Sequence Number: 2925580
• Product Code: KRD
• UDI-Device Identifier: 00847536032323
• UDI-Public: 00847536032323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: 01/17/2023
• Device Model Number: APB-4-12-HX-SS
• Device Catalogue Number: APB-4-12-HX-SS
• Device Lot Number: A962354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/02/2020
• 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: Required Intervention
• Patient Age: 41 YR