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

Model Number	APB-3-4-3D-ES
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the physician information could not be provided due to restriction by privacy regulations.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil detached early and deviated from the aneurysm.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the internal carotid-posterior communicating (i c-pcom) aneurysm.The max diameter was 5mm, and the neck diameter was 4mm.The patient's blood flow was normal, and the vessel tortuosity was moderate.It was reported that when the fourth coil was placed there was a slight deviation from the outside of the aneurysm.Insertion was completed after inserting and removing it twice.The coil was appropriately detached with a detacher, but when the delivery pusher was pulled out, it was suspected to be stretched.The microcatheter was also removed on the assumption that something remained in the microcatheter; however, the third coil deviated from the aneurysm so it was collected with a snare.There was coil damage/early detachment.No additional medical/surgical interventions were needed.There was no damage to the delivery pusher, and there had been no resistance during delivery.The coil had been repositioned twice, and no detachment attempts were made.The pusher was not rotated inside the patient's body.A continuous flush had been administered. the patient did not experience any injury.The devices were prepared according to the instructions for use (ifu).Ancillary devices include a headway 17 microcatheter and a chikai 14 guidewire.Additional information received indicated both coils (apb-2-3-3d-es and apb-3-4-3d-es) were removed from the patient.Only the apb-2-3-3d-es coil detached early.There were no issues observed during preparation or insertion that would have contributed to the event.Refer to manufacturer report 2029214-2021-01046 for details pertaining to the related reportable event.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12439557
• Report Number: 2029214-2021-01126
• Device Sequence Number: 14331787
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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 Date: 10/30/2023
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 221070142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1