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

Model Number	QC-5-10-3D
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
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 the axium coil was found stretched and prematurely detached.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm in the left posterior communicating artery with a max diameter of 5.2 mm and a 3.2 mm neck diameter.It was noted, the patient's blood flow was normal and vessel tortuosity was normal.It was reported, that after the spring coil entered the microcatheter, only the detachment point was seen under the x-ray and the spring coil body was not found.So, it was pulled out of the body for inspection.And it was found, that the coil body had been stretched.It was reported, coil separation/break/premature detachment occurred.The implant coil was removed from the patient by removing with the microcatheter.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.The physician did not attempt to detach the coil.The continuous flush was administered, during the procedure.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.
Event or Problem Description
Additional information received reported that the cause of the premature detachment and coil stretch was not determined.There were no issues that resulted in the damage that was found.The catheter used in the event was an sl-10.This coil was the first coil used in the procedure, and 4 coils were subsequently filled.
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.
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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
Additional information was received that the coil did not separate and did not prematurely release from the wire.
Event or Problem Description
Additional information was received that the coil body of the spring coil was stretched but not separated.The report was incorrectly expressed.
Additional Manufacturer Narrative
H3: product analysis as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box; within a sealed biohazard pouch and within a dispenser track.The axium implant coil was returned within introducer sheath.Visual inspection/damage location details: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.No bends and kinks were found with the axium coil pushwire.The coin was found to be still against the lumen stop.The implant coil was found to be still attached, stretched and damaged within and extending from introducer sheath.No other anomalies were observed.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the implant coil was found to be still attached.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 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: 20507042
• Report Number: 9617601-2024-00249
• Device Sequence Number: 8380835
• Product Code: KRD
• UDI-Device Identifier: 00847536037809
• UDI-Public: 00847536037809
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/08/2025

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: QC-5-10-3D
• Device Catalogue Number: QC-5-10-3D
• Device Lot Number: 228045491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2024
• Supplement Date Received by Manufacturer: 10/24/2024; 11/19/2024; 12/20/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/15/2024; 12/10/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: 72 YR
• Patient Sex: Male