MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2-4-3D
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis: ¿ equipment used: video inspection system (m-78210), ruler (m-83361) ¿as found condition: the axium pushwire was returned for analysis within a shipping box; and within a plastic bio-pouch.¿ damage location details: the axium pushwire was returned all over tangled and bent.The axium implant coil was found to be detached and not returned for analysis.Therefore, any contributing factors could not be assessed.The coil shield was found to be stretched.No other anomalies were observed.¿conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretched¿ could not be confirmed as the axium implant coil was found to be detached and not returned for analysis.However, the root cause could not be determined.This event is reported at this time based on conservative review of analysis results which indicate the possibility of a reportable device malfunction.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the coil was stretched.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the right internal carotid artery, c6 segment with a max diameter of 3mm and a 1mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the package was opened and hydrated, then delivered into the microcatheter.It was found that the spring coil was stretched and was withdrawn from the body.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.Additional information received reported that there were no issues that resulted in the damage that was found.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19607857
• Report Number: 9612164-2024-02988
• Device Sequence Number: 15023325
• Product Code: KRD
• UDI-Device Identifier: 00847536037625
• UDI-Public: 00847536037625
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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
• Report Date (Section B): 06/25/2024

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 Expiration Date: 02/18/2026
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 226008763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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: 66 YR
• Patient Sex: Male