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

Model Number	QC-2-4-3D
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that an axium coil was difficult to detach.The patient had a ruptured aneurysm at the basilar artery apex.After the long sheath and intermediate catheter were put in place under the guidance of the guidewire and catheter, the echelon10 microcatheter was placed into the aneurysm body, and qc-6-20-3d, qc-4-12-3d, and qc-3-8-3d coils were delivered in sequence.The delivered qc-2-4-3d was difficult to detach, so it was immediately removed from the body for inspection, and it was found that the spring coil was stretched.For the sake of patient safety, it was decided to replace a new apb-1.5-4-3d coil.After the replacement, the surgery continued.Finally, after deploying the two apb-1-3-3d coils, the surgery was successfully completed.The devices were prepared according to the instructions for use (ifu).The patient was being treated for an unruptured, saccular aneurysm in the basilar artery.The max diameter was 4mm and the neck diameter was 2.1mm.Patient blood flow was normal and vessel tortuosity was minimal.No patient symptoms or complications were reported.
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
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 there were no issues that resulted in the damage that was found.There were 0 attempts at detachment with the instant detacher and 2 attempts at manual detachment.Prior to coil non-detachment, there were no issues encountered.The pushrod was kinked.
Additional Manufacturer Narrative
Product analysis #(b)(4):¿ equipment used: vis (m-78210) ¿ as found condition: the axium coil was returned for 4nalysis within a shipping box, a plastic bio-pouch, and a dispenser coil.The axium coil was returned within its introducer sheath.¿ damage location details: the axium pusher actuator interface (ai) and hypotube break indicator (hbi) were found intact.No breaks or separations were found with the pusher.The axium implant coil was found stretched and kinked within the introducer sheath.¿ testing/analysis: the axium coil was pulled out from within its introducer sheath for detachment testing.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿pusher kink/damage¿ report could not be confirmed.No damages were found with the pusher of the returned axium coil.Regarding the customer¿s report of ¿coil stretch¿, the issue was confirmed.Possible causes of ¿coil stretch¿ include lack of hydration before procedure, user does not maintain a continuous flush, tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pusher rotation, user advances coil against resistance, or use of an incompatible catheter.However, the cause of the coil stretch could not be determined.Regarding the customer¿s ¿non-detachment¿ report, the issue was confirmed as the implant coil was found still attached to the pusher.However, the implant coil detached as intended during testing.It was reported that two manual detachment attempts were performed; however, the pusher hypotube break indicator (hbi) was intact, and no other breaks or separations were found with the pusher.Additional clarification on the exact sequence of events is needed to determine the cause.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 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20207754
• Report Number: 9612164-2024-04184
• Device Sequence Number: 6815872
• 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
• 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): 11/25/2024

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: 09/03/2026
• Device Model Number: QC-2-4-3D
• Device Catalogue Number: QC-2-4-3D
• Device Lot Number: 227286470
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/31/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/04/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2023
• 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: 81 YR
• Patient Sex: Female