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

Model Number	APB-5-15-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	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): three axium prime coils were returned for analysis within a shipping box; within an their axium prime coil outer cartons; within their opened axium prime coil inner pouches and within individual dispenser tracks.The axium prime coils were returned within their introducer sheaths.Visual inspection/damage location details: (pli-10) the axium prime coil pushwire was found to be bent at ~114.8cm from proximal end.The implant coil was found to be stretched and damaged within the introducer sheath.The coil was unable to be pushed out from within the introducer sheath for further evaluation as it was found to be stuck within the introducer sheath.All other subassemblies appeared to be normal, and no other anomalies were observed.(pli-20) the axium prime coil pushwire was found to be kinked at ~26.2cm and at ~33.5cm from proximal end.The implant coil was found to be stretched and damaged within the introducer sheath.The coil was unable to be pushed out from within the introducer sheath for further evaluation as it was found to be stuck within the introducer sheath.All other subassemblies appeared to be normal, and no other anomalies were observed.(pli-30) the axium prime coil pushwire was found to be broken at actuator interface.The coin was found to be not against the lumen stop.The shield coil was found to be stretched.The implant coil was found to be already detached and not returned.All other subassemblies appeared to be normal, and no other anomalies were observed.Testing/analysis (including sem reports): the axium prime coils could not be used for resistance testing with an in-house micro catheter due to their damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ were confirmed.However, the cause could not be determined.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.The model and lot numbers were not provided; therefore, compatibility could not be assessed.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 encountered resistance and became stuck in the middle of the catheter.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for neurovascular abnormalities (e.G.Arteriovenous malformations or fistulae) with a ccf grade type of abnormality.It was unknown if the abnormality was located in the eloquent region.The patient¿s blood flow was normal and vessel tortuosity was moderate.The catheter was not damaged.It was unknown if the coil was damaged.It was a ccf case and when pushing coils through the catheter, they faced high resistance.Coil (lot # 228640123) pushwire was damaged at the proximal segment.The healthcare provider removed the coils and went with other coils.There were no patient symptoms or complications associated with this event.Additional information was received that the patient was being treated for a 6mm carotid cavernous fistula.Vessel tortuosity was moderate.The cause of the resistance was not determined.The coil came out very smoothly from the sheath.The catheter used was not a medtronic product.There were no issues that resulted in the damage that was 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: 20824749
• Report Number: 9617601-2024-00366
• Device Sequence Number: 8716607
• Product Code: KRD
• UDI-Device Identifier: 00847536038578
• UDI-Public: 00847536038578
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/02/2024

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-5-15-HX-SS
• Device Catalogue Number: APB-5-15-HX-SS
• Device Lot Number: 228640123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown