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	Break (1069); Separation Failure (2547)
Health Effect - Clinical Code	Muscle Weakness/Atrophy (1967)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id apb-1.5-4-hx-es (227755126); 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.
Event or Problem Description
Medtronic received a report that an axium coil would not detach.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for an unruptured posterior communicating artery aneurysm with a saccular morphology.Aneurysm dimensions: max diameter 6 mm and neck diameter 3 mm.The patient's blood flow was normal and the vessel tortuosity was moderate.When the surgeon used the coil to embolize the middle cerebral artery aneurysm, he used the qc5-10-3d coil.The embolization was satisfactory, and when he was ready to detach the coil, he used the alternative detachment method and broke the spare detachment point by hand and found that the coil was not detached.He pulled out the detachment wire for observation and found that the proximal end of the detachment wire was short and broke in advance.The physician used sterile needle-nosed pliers to twist off the proximal pusher rod, found the tail end of the broken detachment wire in the pusher rod and pulled it out, and then the detachment was successful.The physician did not attempt to detach the coil with the instant detacher.A manual attempt at detachment via hypotube was made a total of 5 times.The patient's muscle strength deteriorated on the first day after surgery and returned to normal on the third day.Ancillary devices: microcatheter echelon lot 02281354, guidewire stryker.
Event or Problem Description
Additional information received that the cause of the broken axium coil was not determined.The coil was implanted in the intended location.
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.

• 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: 20521670
• Report Number: 9617601-2024-00256
• Device Sequence Number: 18091225
• Product Code: KRD
• UDI-Device Identifier: 00836462010369
• UDI-Public: 00836462010369
• 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
• Report Date (Section B): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 228297396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/19/2024
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 66 YR
• Patient Sex: Female