MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-6-HX-ES
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the embolization of an unruptured, saccular aneurysm in the right ophthalmic artery, there were suspected coil stretches during the delivery of the axium prime bare hx 2mm x 6cm extra (apb-2-6-hx-es) and axium prime bare 3d 3mm x 6cm extra soft (apb-3-6-3d-es).The apb-2-6-hx-es experienced friction or difficulty during delivery, and the coil stretch/damage was noted at the pushwire middle segment.The apb-3-6-3d-es had a coil stretch at the pushwire distal segment.The delivery of other spring coils was normal and the operation was successful.The aneurysm dimensions measured a max diameter of 3.66 mm and a neck diameter of 2.15 mm.The patient's blood flow was normal and vessel tortuosity was minimal.The physician did not reposition the coil during the procedure.The surgeon removed the coils and continued the operation.Continuous flush was administered during the procedure.No patient complications have been reported as a result of this event.Additional information received reported that the cause of the stretch/ pushwire damage/ resistance was not determined.When the spring coil was delivered to the middle section, resistance was generated.The coil was smoothly delivered from the introducer sheath to the microcatheter.There was no kink/damage to the catheter observed after removal.There were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): axium prime implant coils were returned for analysis within a shipping box, a sealed plastic biohazard pouch, and individual opened axium prime implant coil inner pouches.The microcatheter mentioned was not returned.Damage location details: the axium prime implant coil was returned with the incorrect introducer sheath, which was found to be broken and damaged.The pushwire was returned kinked (crushed) at ~6.4cm, bent at ~68.4cm, and broken (into two pieces) at ~146.7cm from the proximal end; however, the other broken half was found to be broken at ~46.6cm, and bent multiple times within the introducer sheath at ~25.3cm from the distal end.The axium prime implant coil was found to be broken off within the introducer sheath, which was then found to be stretched and damaged within the introducer sheath.In addition, the polypropylene filament was intact and still attached to the detachable element.No other anomalies were observed.Testing/analysis (including sem reports): due to the damaged condition of the implant coil, no further testing was performed in-house.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil stretch¿ was able to be confirmed, and the root cause could not be determined.The pushwire was returned bent and broken into two pieces.The axium prime implant coil was returned damaged (stretched) and broken off within the introducer sheath.Advancing the implant coil against the reported resistance could lead to possible damage; therefore, the damage may have occurred while the user advanced the coil into the microcatheter.No mention of the devices used in the procedure being prepared per the ifu was reported; however, the customer did note that ¿continuous flush was administered during the procedure.¿ the patient's blood flow was reported to be normal, and vessel tortuosity was minimal.Possible causes for failure are, but not limited to, lack of hydration before, pushwire rotation, and user advances the coil against resistance.The echelon-10 used in the procedure was not returned.Via an online source, the echelon-10 was found to be compatible with the axium prime implant coil.(apb-2-6-hx-es).The customer's report of ¿coil resistance/stuck in catheter¿ was unable to be confirmed, and the root cause could not be determined.No microcatheter was returned for evaluation.The implant coil was returned damaged, so no further testing could be performed.Possible causes for failure are, but not limited to, lack of hydration before procedure, and damage or kink to the pushwire.The report of ¿pusher kink/damage¿ was able to be confirmed, and the root cause was unable to be determined.The pushwire was found to be kinked, bent, and broken, thus confirming the report.Possible causes for failure are, but not limited to, user advances coil against resistance.No patient complications have been reported because of this event.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.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21985553
• Report Number: 9617601-2025-00447
• Device Sequence Number: 15531840
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 227852225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 55 KG