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

Model Number	QC-1.5-2-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of qc-1.5-2-helix, lot no:226008760 as found condition: the axium device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within its introducer sheath.Visual inspection/damage location details: the introducer sheath was found properly assembled on the pusher with the wavelock at the proximal end.No damages or irregularities were found with the introducer sheath.The three tack welds were found broken (figure c).The distal ~6.0cm of the axium prime pusher was found bent/kinked.The axium prime implant coil was found damaged and stretched within the introducer sheath with the polypropylene filament broken.Testing/analysis: the axium prime implant coil could not be advanced out of the introducer sheath as it was found to be stuck and was retracted out instead.The axium prime implant coil tip od (outer diameter) was measured and found to be 0.0111¿ which is within specification (specification: 0.0112¿ +.0010/-.0020).The introducer sheath id (inner diameter) was measured and found to be 0.0190¿ (0.4826mm) which is within specification (specification: 0.47mm +0.03mm/-0.00mm).No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.The axium prime implant coil was found damaged/stretched and the pusher was found damaged.There were no reported issues pushing the axium prime implant coil from within the introducer sheath during hydration per ifu.Therefore, it is possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (over tightening of the rhv/sheath not fully seated within the hub) subsequently causing the implant coil to become stuck.Advancing the coil against resistance would result in damage to the implant and pusher.The tack welds were found broken.It is also possible the damage occurred due to retracting against the reported resistance.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 two coils encountered resistance in the sheath.The patient was undergoing surgery for treatment of an amorphous, unruptured c7 aneurysm with a max diameter of 4.3mm and a 2.1mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that during the aneurysm surgery, the coils could not enter the microcatheter.The devices were replaced, and the surgery went smoothly.The reported devices and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information received that during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• 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: 19949987
• Report Number: 9612164-2024-03652
• Device Sequence Number: 8785243
• Product Code: KRD
• UDI-Device Identifier: 00847536037229
• UDI-Public: 00847536037229
• 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): 08/09/2024

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: 02/15/2026
• Device Model Number: QC-1.5-2-HELIX
• Device Catalogue Number: QC-1.5-2-HELIX
• Device Lot Number: 226008760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: 73 YR
• Patient Sex: Male