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

Model Number	QC-7-30-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition- the axium device was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.No other accessories were returned.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube and the break indicator was found intact.There were no evidence of detachment attempts at these locations using an instant detacher or by manual method.The axium pusher was found bent at ~66.2cm from the proximal end (figure g).The coin was still against the lumen stop; the shield coil was found undamaged; and the implant coil was still attached to the pusher (figure h).The axium implant coil was found stretched and damaged with the polypropylene filament unbroken (figure i).Testing/analysis ¿ an in-house instant detacher was used for detachment testing.No difficulty was experienced inserting the pusher into the instant detacher, and the load indicator was not visible when the pusher was fully seated in the instant detacher cap, which is normal.The implant coil was successfully detached on the first attempt without any difficulty (figure j).Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed and the cause could not be determined.The failure could not be replicated as the device detached with no issues on the first attempt using an in-house instant detacher.The instant detacher used in the event was not returned for analysis.Therefore, any contribution of the instant detacher towards the non-detachment and conformance to specification could not be assessed.The pusher was found bent and the implant coil was found damaged/stretched; however, these damages did not contribute towards the reported failure.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
It was reported that during an intracranial aneurysm embolization procedure, the tip end of the echelon 10 45° pre-shaped microcatheter was found to be damaged after shaping.The procedure involved accessing the femoral artery to treat an unruptured, saccular aneurysm located in the ophthalmic artery with normal vessel tortuosity and blood flow.The maximum diameter of the aneurysm was 7 x 8 mm and the neck diameter was 5 mm.The damaged microcatheter was replaced with another microcatheter.Subsequently, a detachable spring coil qc-7-30-3d was selected to form a hoop, but it could not be detached despite multiple attempts.The coil was withdrawn, and another spring coil was used, allowing the operation to be successfully completed.The product was replaced by another medtronic product.The catheter was flushed as indicated in the instructions for use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id 145-5091-150 (lot: 0229107611); product type: ; implant date n/a; explant date n/a.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
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 received that the catheter was positioned 2-3 cm from the heat source during shaping.The catheter was shaped with the heat source foe 5 seconds.There were 0 attempts made to detach the coil using the instant detacher.There were 2 attempts were made to detach the coil using the manual method.Prior to coil non-detachment, there were no issues encountered.There was no pushwire damage observed after removal from the patient.

• 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: 21078591
• Report Number: 9617601-2025-00026
• Device Sequence Number: 18239117
• Product Code: KRD
• UDI-Device Identifier: 00847536037878
• UDI-Public: 00847536037878
• 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: 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,Followup,Followup
• Report Date (Section B): 03/19/2025

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-7-30-3D
• Device Catalogue Number: QC-7-30-3D
• Device Lot Number: 228436960
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/10/2025; 02/28/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown