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

Model Number	QC-2-6-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium coil couldn't be detached.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured c6 aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 2.61 mm and neck diameter 2 mm.The vessel tortuosity was minimal and blood flow was normal.The physician made 3 attempts to detach the coil with the instant detacher.The physician tried to detach with another instant detacher.There were 2 manual attempts at detachment via hypotube.There were no patient symptoms or complications associated with this event.
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 reporting that after taking out the coil that could not be detached, the coil was replaced and filled, and the detachment was successfully achieved.The cause of the non-detachment was not determined.Prior to coil non-detachment, no issues were encountered.There was no pushwire damage observed after removal from the patient.
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: product analysis of qc-2-6-3d, item:10,lotno:225790126 as found condition- the axium coil was returned for analysis within shipping box; within sealed plastic biohazard pouch; within sealed tyvek biohazard pouch; within dispenser coil and within introducer sheath.The two instant detachers used during the event were not returned for analysis.Visual inspection/damage location details - the axium pusher was found broken proximal to the break indicator.It is likely manual detachment was attempted at this location.The proximal segment (actuator interface, positive load indicator, and portion of the coupler tube) was not returned for analysis.The coin and release wire were fully retracted out of the lumen stop/pusher and not returned for analysis.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found stretched and damaged with the polypropylene filament unbroken.The retainer ring was found severely crushed/ovalized.No damages or irregularities were found with the detach element stick or ball.Testing/analysis ¿ the implant coil was pulled distally, and the implant detached after significant manipulation.The inner diameter of the retainer ring could not be reliably measured due to the damage.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the device was returned with the implant coil still attached.The likely cause of the non-detachment is damaged retainer ring, causing the detach element to become stuck.The cause of the retainer ring crush could not be determined.As the proximal pusher, release wire/coin, and instant detacher used during the event was not returned for analysis, any contribution of the subassemblies and instant detacher towards the non-detachment could not be determined.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; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19105325
• Report Number: 2029214-2024-00650
• Device Sequence Number: 7840216
• Product Code: KRD
• UDI-Device Identifier: 00847536037632
• UDI-Public: 00847536037632
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

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: 01/15/2026
• Device Model Number: QC-2-6-3D
• Device Catalogue Number: QC-2-6-3D
• Device Lot Number: 225790126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 05/31/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/09/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2023
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG