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

Model Number	APB-4-12-3D-SS
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil did not change when the delivery rod was pushed forward and withdrawn.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left middle cerebral artery with a max di ameter of 4.2 mm and a 2.3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that middle cerebral artery aneurysm, blood vessels were measured after angiography, the aneurysm size was 4.2mm x 3.6mm, 6f-90 long sheath + 6f105navien was used for access, synchro14 guide wire 105-5091-150 microcatheter passed through the guide wire to the m3 segment, the guide wire was withdrawn, and another 145-5091-150 was used and pushed to the aneurysm, and then apb-4-12-3d-ss was filled after hydrophilic.After filling more than half, forming a hoop was not ideal, so it was withdrawn and adjusted and re-filled.When re-filling half of the adjustment, it was found that the spring coil did not change when the delivery rod was pushed forward and withdrawn.After it was withdrawn from the body together with the microcatheter, it was found that the stretched wire of the coil was stretched in advance in the delivery rod.Then the microcatheter was pushed again, and select one piece each of qc-4-8-3d/apb-2-8-helx/apb-1.5-4-3d-es and complete the filling successfully.It was reported there was coil separation/break/premature detachment that occurred.The implant coil was removed from the patient.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.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 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.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported that the cause of the premature detachment was not determined.It was noted that the coil was stretched.The coil did not prematurely detach, it was half filled then stretched.There were no issues that resulted in the damage that was found.The faulty coil was the first coil used, then two were used to fill.The coil was removed from the patient.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: video inspection system (m-85519), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch; within an opened axium prime inner pouch and outside its returned introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The coin was found still against the lumen stop.The shield coil was found undamaged.The implant coil was found separated from the detach element and not returned for analysis.No damages or irregularities were found with the detach element.Testing/analysis: n/a conclusion: based on the analysis performed, the customer report of ¿coil stretch¿ and ¿premature detachment" was confirmed.The cause of the premature detachment was found to be the implant coil separation/break from the detach element.The implant coil would likely have been stretched prior to the separation as the cause would be the same for both.Possible causes for coil stretch/separation include, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, damaged micro catheter, or user advances the coil against resistance.Customer reported vessel tortuosity as minimal, no friction was encountered during delivery, no rotation of the pusher during procedure, continuous flush was administered, and devices were prepared per ifu.The likely cause could not be determined.As the echelon-10 micro catheter used during the event was not returned for analysis, any contribution of the echelon-10 micro catheter towards the coil stretch and premature detach could not be determined.H6.Coding updated based on analysis findings.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: 19484495
• Report Number: 9612164-2024-02729
• Device Sequence Number: 20867888
• Product Code: KRD
• UDI-Device Identifier: 00847536038240
• UDI-Public: 00847536038240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 08/09/2024

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-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: 228091505
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 06/16/2024; 07/26/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/12/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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 Age: 56 YR
• Patient Sex: Female