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 Codes	Difficult or Delayed Positioning (1157); Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Rupture (2208)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: fg11150-0615-2s (223165486).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that an axium coil encountered resistance with the catheter and jumped during deployment.The aneurysm ruptured and the vessel was damaged.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left anterior communicating artery with a max diameter of 5.5 mm and a 3.9 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that during advancement of the 3-4 3d es coil resistance was felt and then relieved.Upon a run microcatheter was observed through the aneurysm wall.Coil was detached and subsequent coils placed.It was reported difficult placement occurred.The coil was implanted at the intended location.The device jumped during deployment.The vessel was damaged that was related to the coil.The tip of the catheter moved during deployment.The physician did not rotate the delivery pusher during the procedure.The aneurysm did rupture which was related to the coil.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported the aneurysm rupture was treated with placement of additional coils until no further extrav asation was observed.The vessel was not perforated.The aneurysm was perforated.Resistance was believed to be caused by the stent in the parent vessel trapping the microcatheter against the vessel wall so coil resistance could not be felt properly.The doctor did have a fair amount of forward load on the microcatheter because of the acute angle into the aneurysm.No resistance was felt while advancing the coil.Resistance was felt with deploying the coil into the aneurysm.The coil came out of the introducer sheath smoothly.There was no damage to the coil observed after removal.There was no damage to the phenom catheter.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received that the patient was recovering well from the procedure.The patient has not received and is not planned for any medical/surgical intervention as a result of the coil movement during deployment.The patient was heparinized during procedure and protamine was administered after the rupture.No other antiplatelet was administered.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20666388
• Report Number: 9617601-2024-00300
• Device Sequence Number: 18194877
• Product Code: KRD
• UDI-Device Identifier: 00847536021228
• UDI-Public: 00847536021228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 06/17/2025
• Device Model Number: APB-3-4-3D-ES
• Device Catalogue Number: APB-3-4-3D-ES
• Device Lot Number: 224564458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 12/13/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/06/2024; 01/08/2025
• Date Device Manufactured: 06/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG