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

Model Number	APB-2-6-HX-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the axium prime device was returned for analysis.The echelon -10 micro catheter used in the event was not returned for analysis.No damages or irregularities were found with the axium prime pusher.The axium prime implant coil was found severely stretched with the polypropylene filament broken.The axium prime device could not be used for resistance testing with an in-house micro catheter due to the damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ was confirmed as the damages found is consistent with resistance.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, micro catheter damage, or use of an improper hubbing technique (over tightening of the rhv/sheath not firmly seated into hub).The returned axium prime coil was found stretched.It is possible the damage occurred during the attempt to push the coil into the micro catheter hub against the reported resistance.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-10 micro catheter as the echelon-10 micro catheter has an inner diameter of 0.0165¿.Customer reported that the introducer sheath was held vertically during retraction of the device following hydration.However, customer also reported the sheath was not found, which is contradictory.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 an axium coil was stuck in the catheter/sheath and stretched.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a ruptured small aneurysm of the right posterior communicating artery with an amorphous morphology.Aneurysm dimensions: max diameter 4.5 mm and neck diameter 3.2 mm.The patient¿s blood flow and vessel tortuosity was normal.When the coil was pushed into the microcatheter after hydration, great resistance was found.When it was withdrawn from the body, it was found that the spring coil had been stretched.The resistance was found in the proximal end of the catheter.The coil pushed smoothly out from the sheath.The catheter was not damaged.It was unknown if the coil was damaged.There were no patient symptoms or complications associated with this event.Additional information received reported that the coil was replaced to complete the procedure.The cause of the coil resistance/stretch was not determined.There were no issues that resulted in the damage that was found.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.Resistance was present proximal to the microcatheter.It was also note that ¿the sheath was not found.¿.

• Brand Name: AXIUM PRIME BRPL HLX
• 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 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20846462
• Report Number: 9617601-2024-00370
• Device Sequence Number: 3758098
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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): 12/04/2024

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: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 227937230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: 61 YR
• Patient Sex: Female