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

Model Number	APB-3.5-8-3D-ES
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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 coil prematurely detached.The patient was undergoing treatment for am unruptured, saccular aneurysm located in the right mca bifurcation.The max diameter was 5.7mm.The neck diameter was 2.3mm.The patient¿s blood flow was normal, and the vessel tortuosity was moderate.It was reported that when deploying the device, the coil was detached immediately inside the microcatheter before complete detachment in the aneurysm wall.The physician had not attempted to detach the coil.The pushwire was not bent or broken, and there had not been any friction or difficulty during delivery.The physician did not reposition the coil, and a continuous flush was administered.The patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).Ancillary devices include an envoy guide catheter, echelon 10 microcatheter, and avigo guidewire.

• 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: 11338782
• Report Number: 2029214-2021-00179
• Device Sequence Number: 3373094
• Product Code: KRD
• UDI-Device Identifier: 00847536021266
• UDI-Public: 00847536021266
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• 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): 02/17/2021

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-3.5-8-3D-ES
• Device Catalogue Number: APB-3.5-8-3D-ES
• Device Lot Number: A928321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR