MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-5-10-3D-SS
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
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 a report that an axium coil encountered resistance in the sheath and was found to have broke.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).When inserting the coil into the microcatheter, there was resistance inside the introducer sheath, so it could not be advanced.When the coil was removed from the introducer sheath and checked externally, breakage to the coil was observed.There were no patient symptoms or complications associated with this event.
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 reported the lesion being treated was an internal carotid- pc 7mm.Vessel tortuosity was normal.The coil was replaced to resolve the resistance.The catheter was another companies product.The procedure was completed with another product.
Additional Manufacturer Narrative
Product analysis #809709626:¿ equipment used: video inspection system (m-85519), ruler (m-83361), pin gages (m-84080; m-84083); camera (panasonic lumix dmc-zs5) ¿ as found condition: the pushwire was returned for evaluation inside the introducer sheath, a biohazard bag, and a shipping box.The implant coil and catheter were not returned.The catheter's size and model were not reported.Therefore, any contributing factors from the catheter to the reported issue could not be determined.¿ visual inspection/damage location details: the implant coil appeared broken from the pushwire.The shield coil was found intact with no damage.The coil was found against the lumen stop.The break indicator, ai, and coupler tubing were intact and had no damage.The distal pushwire was kinked at 4.0cm to 9.0cm from the retainer ring.¿ testing/analysis: the pushwire was pushed out from the introducer sheath with difficulty.The introducer sheath id (inner diameter) was measured to be 0.0185" and found to be within specifications.The ¿wave lock¿ portion of the introducer sheath was present near the proximal end.Since the implant coil was not returned.The coil tip outer diameter could not be measured.¿ conclusion: based on the device analysis and reported information, the customer complaint was confirmed as the implant coil was separated from the pushwire.The distal pushwire was damaged.These damages likely occurred when the customer attempted to advance the coil through the catheter against the resistance.The cause could not be determined.Possible causes include using damaged/incompatible catheter and/or due to an improper hubbing technique (over-tightening of the rhv).Since the catheter and implant coil were not returned, any contribution of the catheter and implant coil 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 PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; 9775 toledo way; irvine CA 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; 9775 toledo way; irvine CA 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19704525
• Report Number: 9612164-2024-03173
• Device Sequence Number: 19758280
• Product Code: KRD
• UDI-Device Identifier: 00847536008182
• UDI-Public: 00847536008182
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2024

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 Model Number: APB-5-10-3D-SS
• Device Catalogue Number: APB-5-10-3D-SS
• Device Lot Number: 227675866
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 08/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/30/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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 Sex: Unknown