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

Model Number	QC-6-20-HELIX
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two axium coils were found stretched.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the internal carotid artery.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the axium spring coil was stretched.After replacement, it was successfully implanted.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.Additional information received that the cause of the coil stretch was determined.There were no issues that resulted in the damage that was found.Additional information was received.It was clarified that the cause was undetermined.
Additional Manufacturer Narrative
The event is reported at this time based on analysis findings which indicate a possibly reportable event.Since it was unclear which device was which, reports will be submitted for both devices.H3.Product analysis: equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): two axium implant coils were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The axium implant coils were returned without introducer sheaths.Visual inspection/damage location details: due to the condition in which the coils were returned, it is unable to be determined which coil belongs to which pli.(coil 1) the axium implant coil pushwire was found to be broken at load indicator and kinked at ~150.9cm from proximal end.The axium implant coil was found to be stretched and damaged.No other anomalies were observed.(coil 2) the axium implant coil pushwire was found to be kinked at load indicator ~3.0cm from proximal end and broken but retained by release wire at break indicator.The axium implant coil was found to be stretched and damaged.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was confirmed.There was no reported issue pushing the axium implant coils out from within their introducer sheaths.Therefore, it is possible the axium coils became damaged upon removal from within introducer sheaths; however, the root cause 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 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: 19842753
• Report Number: 9612164-2024-03439
• Device Sequence Number: 12411750
• Product Code: KRD
• UDI-Device Identifier: 00847536037434
• UDI-Public: 00847536037434
• 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
• Report Date (Section B): 07/26/2024

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: 03/26/2026
• Device Model Number: QC-6-20-HELIX
• Device Catalogue Number: QC-6-20-HELIX
• Device Lot Number: 226235031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2023
• 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 Sex: Female