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

Model Number	QC-1.5-4-HELIX
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
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 an axium coil was found stretched.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the posterior communicating artery with a max diameter of 5.5 mm and a 2.7 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that during the pushing process of the axium coil, it was found stretched.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.Ancillary devices include an 8f guiding sheath, zhongtian 6f guide catheter, echelon catheter, synchro 2 guidewire.Additional information was received that the cause of the stretch was undetermined.The operation was normal, the coil stretched and "wiredrawn".There were no issues that resulted in the damage that was found.Additional information was received that "wiredrawn" was an input error and meant the coil was stretched.It was noted that during the surgical aneurysm filling process, the 4th coil was filled using qc 1.5*4 helix.During the filling process, the spring coil and catheter were pushed normally.When preparing to detach, it was found that the shape of the coil was wrong.It showed that the one coil was stretched and floated into the blood vessel, so the coil was withdrawn as a whole and it was found that the coil was stretched.This was the surgical process.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that the coil "floated into the blood vessel meant that the coil had migrated into the parent artery after being stretched.The coil did not prematurely detach.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19790705
• Report Number: 9612164-2024-03327
• Device Sequence Number: 17944068
• Product Code: KRD
• UDI-Device Identifier: 00847536037243
• UDI-Public: 00847536037243
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233420
• 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): 08/01/2024

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: 03/25/2026
• Device Model Number: QC-1.5-4-HELIX
• Device Catalogue Number: QC-1.5-4-HELIX
• Device Lot Number: 226234965
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/01/2024
• Date Device Manufactured: 03/25/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female