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

Model Number	QC-16-40-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
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 information that an axium coil did not detach.The physician attempted to detache the coil with the instant detacher 5 times.The physician tried to detach with a second detacher 5 times.The physician attempted to detach with the manual method via a hypotube 5 times.There was no issues with the instant detacher.The devices were prepared as indicated in the instructions for use (ifu).The patient was being treated for an unruptured, saccualr aneurysm in the internal carotid artery.The patient's blood flow and vessel tortusoity was normal.No patient symptosm or complications were reported.
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 that the instant detacher lot number was b676425 validity period: 2027-1-7.Prior to coil non-detachment, there were no issues encountered.There was no¿pushwire¿damage observed after removal from the patient; the coil was not damaged.
Additional Manufacturer Narrative
Product analysis # (b)(4): equipment used- vis (m-85519), 203cm ruler (m-83361) as found condition- the axium implant coil was returned for analysis within a shipping box; returned within a sealed plastic biohazard pouch; returned with an opened axium implant inner pouch and returned within a dispenser coil.The instant detacher used during the event was not returned.Visual inspection/damage location details: the axium implant coil was returned within an introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end.No damage or irregularities were found with the introducer sheath.The actuator interface was found to be broken off.The actuator interface was not returned for analysis.The pushwire was found to be bent at 52.8cm from the proximal end; however, the pushwire was also found to be bent within the introducer sheath at 64.7cm from the distal end.No damages or irregularities were found with the axium implant coil, in addition, the implant was found still attached to the pusher.The axium implant coil was returned in good condition.No other anomalies were observed.Testing/analysis ¿ the axium implant coil was unable to be tested in-house due to the returned condition (damaged) conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was unable to be confirmed, and the root cause was unable to be determined.The customer reported that the first id was used 5 times without success, next the customer used a 2nd id 5 times and had no success.The customer noted there were no issues with the ids.The damage caused to the pushwire was likely done by the failed attempts to detach the coil; however, this could not be reproduced.As the instant detacher used during the event was not returned for analysis, any contribution of the instant detacher to the non-detachment could not be assessed.As the proximal pusher segment was not returned, any contribution of the detachment subassemblies of the pusher towards the non-detachment 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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20092112
• Report Number: 9612164-2024-03924
• Device Sequence Number: 15369682
• Product Code: KRD
• UDI-Device Identifier: 00847536037571
• UDI-Public: 00847536037571
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/25/2024

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 Model Number: QC-16-40-HELIX
• Device Catalogue Number: QC-16-40-HELIX
• Device Lot Number: 228484484
• 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: Not provided; 10/30/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/18/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Unknown