MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-6-20-HX-SS
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil encountered resistance in the echelon catheter and was found kinked/damaged.The patient was undergoing surgery for treatment of an amorphous aneurysm in the internal carotid artery (ica) with a max diameter of 7.83 mm and a 4.31 mm neck diameter.It was noted the patient's vessel tortuosity was normal.It was reported that the first coils were successful implanted axium 3d 6-20.Then the physician inserted the second coils axium helix 6-20, but it was stuck 5cm from the proximal microcatheter.It was reported the coil encountered resistance/stuck in proximal section of the microcatheter.There was no catheter damage observed.The coil was observed to be kinked/damaged.There was friction or difficulty during testing or delivery.The continuous flush was administered during the procedure.The damaged/stretched location was on the implant coil.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 was received that the cause of the resistance was not determined.The physician opened another coil after the damaged one, new coil apb-6-12-hx, and it went through the microcatheter successfully.There were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
H3: product analysis of apb-6-20-hx-ss, lotno:227350314 visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The axium prime pusher was found broken at the positive load indicator with the two segments retained by the release wire.The release wire was retracted.The axium prime implant coil was found detached within the introducer sheath.The implant was found damaged within the introducer sheath.Testing/analysis: the axium prime coil could not be advanced out of the introducer sheath and could not be used for resistance testing due to the damaged condition and the implant already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damage to the micro catheter or tortuous anatomy.Customer reported patient vessel tortuosity as normal, continuous flush was used, a different coil had no issues, and devices were prepared per ifu.The returned axium prime implant coil was confirmed to have ¿coil kink/damage¿.Customer reported no issues and no resistance within the introducer sheath during preparation; therefore, it is possible the damages occurred during the attempt to push the coil into the micro catheter against the reported resistance.The likely cause of the resistance and coil damage could not be determined.The pusher was returned broken near the proximal end, which detached the implant coil within the sheath.The cause of the break could not be determined.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the echelon-10 micro catheter towards the resistance could not be assessed.The axium prime coil is compatible for use with the echelon micro catheter.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 PRIME BRPL HLX
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19571296
• Report Number: 9612164-2024-02908
• Device Sequence Number: 20963751
• Product Code: KRD
• UDI-Device Identifier: 00847536013032
• UDI-Public: 00847536013032
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 06/19/2024

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: 09/26/2026
• Device Model Number: APB-6-20-HX-SS
• Device Catalogue Number: APB-6-20-HX-SS
• Device Lot Number: 227350314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: 56 YR
• Patient Sex: Female