MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2-8-HELIX
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that was damaged and broken.The patient was undergoing a coil embolization procedure to treat an unruptured saccular anterior circulation aneurysm.Blood flow was normal.Vessel tortuosity was severe.It was reported that the axium coil and all accessory devices were prepared per the instructions for use (ifu).Continuous catheter flush was administered during the procedure.The first coil was delivered and deployed without issue.The axium coil (model: qc-2-8-helix, lot: 227220762) was the second to be used in the procedure.There was no friction or difficulty but the coil was observed to be stretched during delivery in the microcatheter.It was noted that the coil broke/separated or detached prematurely.The physician had not attempted to detach the coil and did not rotate the pusher wire during the procedure.The pushwire was not bent or broken.The coil was replaced with another of the same model/lot to continue the procedure.No additional intervention was required.There was no harm or injury to the patient.Ancillary device: echelon microcatheter (model/lot unknown).
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
Correction: d3) incorrect manufacturing site information was entered in the previous report submitted today (17-sep-2024).The manufacturing site information has been corrected in this report.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 reported there were no known issues that resulted in the coil damage/break.The coil was not detached so it was not implanted; it was removed from the microcatheter.
Event or Problem Description
Additional information received reported there were no known issues that resulted in the coil damage/break.The coil was not detached so it was not implanted; it was removed from the microcatheter.
Additional Manufacturer Narrative
B5 updated with additional information received.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 #706925545:equipment used: vis (m-85519), 203cm ruler (m-83360) as found condition (condition of returned device): an axium implant coil was returned for analysis within a shipping box and within sealed biohazard pouch.The axium implant coil was returned within introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was securely attached to the coupler tube.No evidence of mechanical detachment using an instant detacher was found at this location.The break indicator was found intact.This is indicative that a manual detachment was not performed.No bends or kinks were found with the axium coil pushwire.The shield coil was found intact with the implant coil still attached.The implant coil was found stretched and damaged with the polypropylene filament intact.No other anomalies were observed.Testing/analysis (including sem reports): n/a.Conclusion: based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwire was returned with the implant coil still attached.Possible causes for ¿coil separation/break¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.Based on the analysis performed, the customers report of ¿coil stretch¿ was confirmed.Possible causes for ¿coil stretch¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.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 S. DE R.L. DE CV; 9775 toledo way; irvine CA 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; 9775 toledo way; irvine CA 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20086922
• Report Number: 9612164-2024-03920
• Device Sequence Number: 18095564
• Product Code: KRD
• UDI-Device Identifier: 00847536037304
• UDI-Public: 00847536037304
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/18/2024

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: 08/26/2026
• Device Model Number: QC-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: 227220762
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 08/29/2024; 10/23/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/17/2024; 09/17/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female