MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3-8-3D-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that an axium spring coil was stretched.It was planned to perform an intracranial aneurysm embolizat ion surgery.The spring coil encountered resistance during the pushing and could not be pushed.After the spring coil was withdrawn, it was found that the spring coil was stretched.The devices were prepared according to the instructions for use (ifu).The patient was being treated for an unruptured, saccular aneurysm in the anterior communicating artery.The max diameter was 4mm and the neck diameter was 2mm.The patients blood flow was normal and vessel tortuosity was moderate.No patient symptoms were reported.Additional information received that the cause of the resistance was not determined.The resistance was in the middle of the catheter.The coil came out of the introducer sheath smoothly.A continuous saline flush was administered and maintained as indicated in the ifu.There was no kink/damage to the coil observed after removal; it was just found to be stretched.There was no kink/damage to the catheter observed after removal.The catheter was a medtronic product.
Additional Manufacturer Narrative
H3: the echelon-10 micro catheter, axium prime device, and second coil pusher segment were returned for analysis.The axium prime pusher was found broken at ~3.6cm from the proximal end.The axium prime implant coil was found severely stretched and damaged, with the polypropylene filament broken.The implant was found entangled with the pusher, echelon-10 micro catheter and the second coil device¿s release wire.The proximal pusher segment and attached release wire was returned.The remaining pusher was not returned.The implant coil was found stretched/damaged/broken within the returned echelon-10.No flash or hub mold were found within the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter hub.No bends or kinks were found with the returned echelon-10 micro catheter body.No damages or irregularities were found with the distal tip and marker bands.Dried blood was found within the micro catheter and on the damaged implant within.The echelon-10 micro catheter was flushed, and water exited out the distal end slowly.Once hydrated, the damaged implant was removed distally from the echelon-10.Coagulated blood was found on the implant.An in-house axium coil was then used for resistance testing.The axium coil was inserted into the hub, through the catheter body and out the distal end with resistance encountered, pushing out dried blood.Subsequent passes with the same coil did not experience any resistance.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿coil resistance/stuck in catheter¿ were confirmed as resistance was encountered during in-house coil resistance testing.The cause of resistance during analysis is due to the dried blood found within the device and on the implant.It is possible insufficient continuous flush was used, causing blood to backflow up the micro catheter and onto the implant.Once the blood was dissolved/broken up, no further resistance was encountered.It is not known the level of coagulation of the blood during the procedure.In addition, no damages or irregularities were found with the echelon-10 that would contribute towards the resistance.The returned axium prime coil was found damaged/stretched and additional implant coil found within the micro catheter was damaged/stretched/broken.It is possible the damages occurred during the attempt to push the coils into the micro catheter against the reported resistance.The axium prime coil is compatible for use with the echelon-10 micro catheter.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 3D
• 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: 21704666
• Report Number: 9617601-2025-00300
• Device Sequence Number: 17329807
• Product Code: KRD
• UDI-Device Identifier: 00763000313746
• UDI-Public: 00763000313746
• 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): 03/27/2025

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-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: 228629814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2024
• 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 Sex: Unknown