MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1-4-3D-ES
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an axium coil that was stretched or prematurely detached.The patient was undergoing a coil embolization procedure to treat a right posterior communicating artery (pcom) unruptured saccular aneurysm.The aneurysm max diameter was 4.1mm and the neck diameter was 2.9mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the devices were prepared and catheter was flushed continuously per the instructions for use (ifu).The catheter was inspected and tested prior to use with no issue reported.  there was resistance during delivery of the axium coil in the distal end of the echelon 10 microcatheter.It was noted that the catheter tip was found to have fallen off during delivery of the coil and leak was observed.Additionally, the coil stretched and detached prematurely.Despite report that the catheter had resistance, the site noted that there was no friction or difficulty during delivery of the coil.The physician did not reposition or attempt to detach the coil.The physician did not rotate the delivery pusher and the pusher was not bent or broken.All system parts were removed and replaced to complete the procedure.No additional surgical or medical intervention was required.There was no harm or injury to the patient.
Additional Manufacturer Narrative
Continuation of d10: product id 105-5091-150 (b559096); product type: ; implant date n/a; explant date n/a a separate report will be submitted for the echelon microcatheter (model: 105-5091-150, lot: b559096) 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.
Additional Manufacturer Narrative
H3: the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium coil pushwire was found to be kinked at ~176.3cm from proximal end.The coin was found to be against the lumen stop.The implant coil was found to be broken and returned.The implant coil was found to be stretched and damaged.No other anomalies were observed.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; 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: 19470519
• Report Number: 9612164-2024-02676
• Device Sequence Number: 20696098
• Product Code: KRD
• UDI-Device Identifier: 00763000313630
• UDI-Public: 00763000313630
• 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,Followup
• Report Date (Section B): 08/07/2024

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-1-4-3D-ES
• Device Catalogue Number: APB-1-4-3D-ES
• Device Lot Number: 227969706
• 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: 06/03/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 61 YR
• Patient Sex: Female