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

Model Number	QC-1.5-3-HELIX
Medical Device Problem Codes	Break (1069); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the spring coil was automatically stretched and the coil body wire drawn.Later, after it was detached, part of it remained in the patient's body, and part of it was removed from the body (partial removal) along with the pusher.There was coil separation/break/premature detachment.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.There was no surgical or medicinal intervention required.The pushwire was bent or broken (not on purpose.There was no friction or difficulty during delivery.The physician did not reposition the coil.The physician attempted to detach the coil.The physician did not attempt to detach the coil with the instant detacher.The physician attempted to detach the coil using the manual method one time.No instant detachers were used.The physician did not  rotate the delivery pusher during procedure.Continuous flush was administered during the procedure.The patient was undergoing surgery for treatment of a saccular, unruptured posterior communicating artery aneurysm with a max diameter of 5.3mm and a 4.7mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.Ancillary devices include a echelon10 microcatheter (lot 0227423957).
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 received clarified that there was "no" coil separation/break/premature detachment.There were no issues that resulted in the damage that was found.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.
Additional Manufacturer Narrative
Product analysis: the break indicator was found broken with the two segments retained by the release wire, indicative of a manual detachment attempt at this location.The coin was found fully retracted out of the lumen stop.The shield coil was found stretched.The implant coil was already detached and not returned for analysis.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: 19839610
• Report Number: 9612164-2024-03436
• Device Sequence Number: 15352127
• Product Code: KRD
• UDI-Device Identifier: 00847536037236
• UDI-Public: 00847536037236
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2024

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 Expiration Date: 03/23/2026
• Device Model Number: QC-1.5-3-HELIX
• Device Catalogue Number: QC-1.5-3-HELIX
• Device Lot Number: 226234956
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 10/03/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/12/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG