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

Model Number	APB-1-1-HX-ES
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was treated for an aneurysm embolization.When the coil was being delivered through the microcatheter, no coil was visible at the tip.Upon removal from the body, no coil was found at the tip, only the push rod.No coil was found in the packaging, so the coil was replaced and a defective product complaint was filed.It was believed that the spring coil was not assembled before the product was shipped.The coil was not found in the packaging.The report that "no coil was visible at the tip" was clarified to mean that there was no spring coil at the tip end of the push rod.There was no premature detachment.There was no separation.There were no detachment attempt.There was no kink/damage observed on the pushwire.The coil was not implanted in the patient.The catheter was a headway17, non-medtronic product.3 coils were implanted before and after this malfunctioned coil.There was no damage or evidence of tampering to the device packaging.The proximal end of the pushwire was secured in the guidewire clip (black rubber stopper) when the package was opened.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured internal carotid artery (ica) aneurysm with a max diameter of 2 mm and a 1.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
Additional Manufacturer Narrative
Product analysis as found condition (condition of returned device): the axium prime device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the introducer sheath was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.No damage or irregularities were found with the actuator interface and the break indicator.No evidence of detachment attempts were found at these locations.The pushwire was found to be bent within the introducer sheath at ~125.7cm and bent at ~163.8cm from the proximal end.The axium prime implant coil was found to be broken off of the pushwire detach element and not returned.The shield coil was found to be damaged.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿part missing/incomplete/loose¿ was unable to be confirmed; however, the event could not be ruled out.The axium prime device was returned with the pushwire bent/kinked and the implant coil broken off and not returned for assessment.Any contribution the axium implant coil had towards the ¿resistance¿ was unable to be assessed.The damage found with the shield coil is consistent with advancing/retracting the coil against resistance.A possible cause of ¿ part missing/incomplete loose¿ could have been caused during preparation.If the axium prime device is improperly prepared (retracted, flushed and resheathed), possible resistance may start to occur.Advancing/retracting against resistance can possibly lead to the axium prime implant coil to detach/breaking off the pushwire detach element.No damage or irregularities were mentioned prior to delivering the axium prime device through the microcatheter; however, the root cause of the ¿part missing/incomplete /loose¿ was unable to be determined.The catheter used in the procedure was a headway17, non-medtronic product.The microcatheter was not returned; therefore, any contribution the microcatheter had towards ¿resistance¿ was unable to be confirmed.The axium prime device was found to be compatible with the headway-17 microcatheter.The report notes that there was no premature detachment, no separation.And/or no detachment attempt made.The device and any accessories were prepared as indicated in the ifu.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: 23386919
• Report Number: 9617601-2025-02227
• Device Sequence Number: 12959551
• Product Code: KRD
• UDI-Device Identifier: 00763000313784
• UDI-Public: (01)00763000313784(17)270801(10)229409078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 10/25/2025

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-1-1-HX-ES
• Device Catalogue Number: APB-1-1-HX-ES
• Device Lot Number: 229409078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: 82 YR
• Patient Sex: Male