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

Model Number	APB-4-10-3D-SS
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2021
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 coil was back flushed and taken in the microcatheter to the aneurysm.As the coil was placed and attempted to be repositioned, the coil was herniating in the patient artery and they found the coil to be stiff and there was friction.The coil was attempted to be pulled back, however, it was stuck and the coil got stretched and detached.The coil was removed using a snare.A continuous flush was used during the procedure.The physician repositioned the coil 2-3 times.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The device and accessory devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with this event.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the daca with a max diameter of 4.2mm and a 1.7mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was severe.Ancillary devices include a cook shuttle guide catheter, a neuron microcatheter, a headway guidewire, and a traxcess.

• 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
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12823444
• Report Number: 2029214-2021-01480
• Device Sequence Number: 4905698
• Product Code: KRD
• UDI-Device Identifier: 00847536032002
• UDI-Public: 00847536032002
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 03/07/2023
• Device Model Number: APB-4-10-3D-SS
• Device Catalogue Number: APB-4-10-3D-SS
• Device Lot Number: A988675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/16/2021
• Date Device Manufactured: 03/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male