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

Model Number	QC-4-8-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the axium coil was returned for analysis.The micro catheter used in this event was not returned.The axium coil was returned already detached from pushwire.The axium implant coil was found to be damaged.No other anomalies were observed.The axium coil could not be used for resistance testing due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ could not be confirmed.The detachment of coil and damaged to implant coil likely occurred due to resistance.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 an axium coil encountered resistance.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured right cavernous segment of internal carotid artery with a saccular morphology.Aneurysm dimensions: max diameter 4.81 mm and neck diameter 2.66 mm.The patient¿s blood flow was normal.The vessel tortuosity was minimal.The spring coil has a large resistance when it was delivered to the microcatheter port multiple times.The microcatheter entered the aneurysm cavity with the guidewire.The first qc-4-8-3d was delivered to the microcatheter port through the y valve, which had a large resistance.It was delivered several times but it was against the catheter.To prevent accidents, the surgeon replaced it with a achieva's coil, and it was delivered normally this time.Then the surgeon used our company's coils and successfully filled 3 coils.When delivering apb-1.5-4-3d-es and apb-1-3-hx-es, they still could not enter the microcatheter.The surgeon replaced it with a achieva's coil, and the embolization was successfully completed.There were no patient symptoms or complications associated with this event.Ancillary devices: achieva coil.

• Brand Name: AXIUM 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: 20739999
• Report Number: 9617601-2024-00322
• Device Sequence Number: 15642199
• Product Code: KRD
• UDI-Device Identifier: 00847536037762
• UDI-Public: 00847536037762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: QC-4-8-3D
• Device Catalogue Number: QC-4-8-3D
• Device Lot Number: 227675859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: 57 YR
• Patient Sex: Male