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

Model Number	APB-1-2-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information received that the coil axium coil apb-1-2-hx-es, lot: 228392618 was detached intentionally.The coil was not implanted.
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
Medtronic received a report that two axium coils encountered resistance in the echelon catheter.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the c4 segment with a max diameter of 3 mm and a 2 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.The patient had a past medical history of high blood pressure and high blood lipids for several years.It was reported that two axium spring coil could not be pushed through the microcatheter, so the coil was removed and the operation was successfully performed with a new coil.It was reported there was coil resistance/coil stuck in the middle of the catheter.Axium coil (lot # 228392618) encountered resistance in the catheter hub and in the distal section of the catheter.There was no catheter or coil damage that occurred.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Additional information received reported that the coils had come out of the introducer sheath smoothly.The cause of the resistance was not determined.Additional information received reported continuous catheter flush was administered.
Additional Manufacturer Narrative
This event is reportable conservatively at this time out of abundant caution based on analysis findings which cannot rule out a reportable event.The incomplete returned device was received appearing consistent with intentional coil detachment.However, the reported information did not report that the coil was detached.H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5 as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a sealed tyvek biohazard pouch; within its dispenser coil and within its introducer sheath.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium prime pusher was found broken at ~6.2cm from the proximal end with the two segments retained by the release wire.The release wire was found partially retracted.The coin was found retracted out of the lumen stop and the axium prime implant coil was already detached and not returned for analysis.Testing/analysis: the axium prime could not be used for resistance testing with an in-house micro catheter as it was already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ could not be confirmed as the device was already detached.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, micro catheter damage, or use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).The pusher was found broken, the coin was found retracted out of the lumen stop, and the implant was found detached as expected by the detachment subassemblies.Customer did not report detaching the device.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the echelon-10 micro catheter towards the resistance could not be assessed.The axium prime coil is compatible for use with the echelon-10 micro catheter as the echelon-10 micro catheter has a minimum inner diameter of 0.0165¿.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: 21210858
• Report Number: 9617601-2025-00107
• Device Sequence Number: 17155160
• Product Code: KRD
• UDI-Device Identifier: 00847536020917
• UDI-Public: 00847536020917
• 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: 2024
• Device Explanted Year: 2024
• 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): 01/24/2025

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-1-2-HX-ES
• Device Catalogue Number: APB-1-2-HX-ES
• Device Lot Number: 228392618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG