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

Model Number	APB-2-8-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: ¿ equipment used: video inspection system (m-85519), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) ¿ as found condition: the axium prime coil was returned for evaluation inside a biohazard bag, and a shipping box.The echelon catheter was not returned.However, the echelon catheter appeared compatible with the coil as it has a labeled inner diameter (id) of 0.017¿.¿ damage location details: the implant coil appeared to be stretched with the polypropylene filament broken.A bend was found at 19.0cm from the proximal end of the pushwire.¿ testing/analysis: the returned coil could not be used for resistance testing due to its damaged condition.¿ conclusion: based on the analysis findings, the customer complaint was confirmed as the returned axium prime coil was found to be damaged.These damages likely occurred when the customer attempted to advance the coil through the catheter against the reported resistance.However, the cause for resistance could not be determined.Possible resistance cause includes using a damaged catheter.Since the catheter was not returned, any contribution of the catheter to the resistance issue could not be determined.The event is reported at this time based on analysis findings which indicated a reportable 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.
Event or Problem Description
It was reported that during an embolization procedure to treat an unruptured, saccular aneurysm located in the left internal carotid artery communicating segment, resistance was encountered during the delivery of the apb-2-8-hx-es spring coil into the proximal end of the microcatheter, preventing smooth delivery.The coil was replaced with a qc-2-6-helix coil, which was delivered successfully.Subsequently, resistance was also encountered during the delivery of the qc-2-8-helix and qc-2-4-helix coils into the proximal end of the microcatheter, preventing smooth delivery.These coils were replaced with other models, which were successfully delivered.The surgeon believed that the apb-2-8-hx-es, qc-2-8-helix, and qc-2-4-helix coils had quality issues and requested their return for identification.The catheter was not damaged, and the coils were not implanted.The patient¿s blood flow was reported as normal, and the vessel tortuosity was minimal.The aneurysm had a max diameter of 4 mm and a neck diameter of 2.5 mm.The procedure was completed using alternative coils.No patient complications have been reported as a result of this event.Additional information was received.The cause of the resistance was not determined.The coils did come out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.The catheter was an echelon.

• 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: 21529058
• Report Number: 9617601-2025-00223
• Device Sequence Number: 20917633
• Product Code: KRD
• UDI-Device Identifier: 00763000313906
• UDI-Public: 00763000313906
• 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): 03/05/2025

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 Expiration Date: 08/27/2026
• Device Model Number: APB-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 227220746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2023
• 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: 61 YR
• Patient Sex: Female