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

Model Number	APB-1.5-2-3D-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	03/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #806897514:equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5, in-house 0.0165¿ mandrel as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a sealed tyvek biohazard pouch and within a headway-17 micro catheter.Visual inspection/damage location details: the headway-17 hub was found undamaged.The axium prime pusher was found extending out the hub.The headway-17 micro catheter was found flattened at ~110.0cm and ~111.0cm from the proximal end (figures e and f).No damages or irregularities were found with the distal tip or marker band.The axium prime pusher was found broken at the break indicator with the two segments retained by the release wire (figure c).The coin was found fully retracted out of the lumen stop.The shield coil was found slightly stretched (figure i).The implant coil was already detached and not returned for analysis.Testing/analysis: the axium prime pusher was advanced and then retracted out of the micro catheter against high resistance.Dried saline was pushed out distally.An in-house 0.0165¿ mandrel was inserted into the headway-17 hub, through the micro catheter and became stuck at ~110.4cm from the proximal end (at the flattened sections).The inner diameter of the micro catheter was measured to be 0.0165¿.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.The cause of the resistance was found to be the catheter flattening.Other possible contributors for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, or tortuous anatomy.Customer reported patient vessel tortuosity as normal, and devices were prepared per ifu.The customer report of ¿coil stretch¿ could not be confirmed as the implant was already detached and not returned for analysis but cannot be ruled out.In addition, the shield coil was found stretched.It is likely the coil stretched due to advancing/retracting against the reported resistance.The headway-17 micro catheter is compatible for use with the axium prime coil.The pusher was found broken at the break indicator, indicative of a detachment attempt; and the implant was already detached.Customer did not report detaching the device and reported the implant was withdrawn out of the body, however, the implant was not returned and was not found within the micro catheter.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
Medtronic received a report that the spring coil could not be pushed out of the microcatheter during the delivery process, and it was withdrawn from the body and found that it had stretched.The coil was stuck in the middle of the catheter.There was no damage observed on the catheter.The implant coil was damaged.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for treatment of a saccular, unruptured left posterior communicating segment aneurysm with a max diameter of 4.7mm and a 2.5mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Ancillary devices include a cook6 sheath, navien 5f guide catheter, microvention, headway 17 microcatheter, synchro2 guidewire.Additional information was received that the coil came out of the introducer sheath smoothly.There were no issues that resulted in the damage that was found.

• Brand Name: AXIUM PRIME BARE PL 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: 19703879
• Report Number: 9612164-2024-03172
• Device Sequence Number: 15383641
• Product Code: KRD
• UDI-Device Identifier: 00763000313647
• UDI-Public: 00763000313647
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/09/2024

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 Expiration Date: 09/01/2026
• Device Model Number: APB-1.5-2-3D-ES
• Device Catalogue Number: APB-1.5-2-3D-ES
• Device Lot Number: 227264339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: 49 YR
• Patient Sex: Female