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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 a report that the axium prime coil prematurely detached.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the left anterior communicating artery.The max diameter was 3mm and the neck diameter was 2.5mm.The patient's blood flow was normal, and the vessel tortuosity was moderate.It was reported that when the device was inserted into the microcatheter and deployed in the aneurysm, the tip of the delivery pusher's hand side was extended 7mm or more while nothing was done.It was slowly removed from the aneurysm in a hurry, but it was pulled halfway because it had already been detached, but the coil came off inside the guide catheter.The entire guide catheter was removed from the body.Afterwards, the device was induced to the aneurysm again and another coil was used.The treatment was completed without any problems, and no additional medical or surgical interventions were needed.There had been no resistance during delivery, and the coil had not been relocated.There had been no attempts made to detach the coil.The delivery pusher was not rotated inside the patient's bode, and 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 an echelon 10 microcatheter and loadmaster 6f 100cm guide catheter.

• 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: 11661466
• Report Number: 2029214-2021-00421
• Device Sequence Number: 19613406
• Product Code: KRD
• UDI-Device Identifier: 00847536021235
• UDI-Public: 00847536021235
• 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): 04/13/2021

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 Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: B130875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1