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

Model Number	APB-4-8-HX-SS
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that one coil had migration after deployment and one coil was damaged inside the sheath.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right posterior communicating artery with a max diameter of 7mm and a large neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that during the embolization procedure, two coils were released in the distal part of the aneurysm sac affected by the rupture in an attempt to interrupt or reduce the bleeding stat.After having released the first spiral (apb-3-4-3d-es lot: 225549299) when releasing the second spiral (apb-2.5-3-hx-es lot: 227777173) the operators noticed that it presented an anomalous shape already inside the protective sheath (it appeared to be rolled up) and they decided not to use it and to use a third spiral (apb-2-3-hx-es lot: 224701063).After having ordered the latter close to the case, they provided for the release.After withdrawing the catheter they noticed that it formed a small tail outside the case but still inside the aneurysm sac.It was them decided to inflate a balloon for a few instants so as to interrupt the flow inside the aneurysm in an attempt to facilitate and accelerate the clot.During the inflation of the balloon, the operators noticed that part of the coil was coming out of the neck of the aneurysm.The coil was not implanted in the intended location.It was implanted at the ict until right m1.At that point, it was decided to interrupt the procedure and see the patient again the next day.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Ancillary devices include a penumbra benchmark 071 mp and ber select guide catheter, echelon 10 microcatheter, asahi intecc guidewire 0.014 x 200, hyperform 4mmx15mm, x-pedion 10, and instant detacher.
Additional Manufacturer Narrative
Continuation of d10: product id apb-2.5-3-hx-es (lot: 227777173); product type: ; implant date n/a; explant date n/a 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.
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 no anomalous shape was determined.There was no issues that resulted in the coil damage.No medical or surgical intervention is planned.The antiplatelet regimen was admnistered after the procedure.No patient symptosm or c omplications were reported.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 19791358
• Report Number: 9612164-2024-03322
• Device Sequence Number: 14490278
• Product Code: KRD
• UDI-Device Identifier: 00847536008175
• UDI-Public: 00847536008175
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 07/11/2025
• Device Model Number: APB-4-8-HX-SS
• Device Catalogue Number: APB-4-8-HX-SS
• Device Lot Number: 224701063
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/08/2024
• Date Device Manufactured: 07/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 82 KG