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

Model Number	APB-1-2-HX-ES
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	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that an axium coil guidewire would not enter the catheter.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was undergoing treatment for clinoid segment ruptured aneurysm with a amorphous morphology.Aneurysm dimensions: max diameter 5 mm, neck diameter 4 mm.The access vessel was the femoral artery (8 mm diameter).The vessel tortuosity was moderate and the blood flow was unknown.During the surgery, the guide wire could not enter the microcatheter.The surgeon even changed two guide wires but it would not enter.It was believed that there was a problem with the microcatheter.When the coil was applied, it was found that the guide wire had been kinked when the coil was opened.There were no patient symptoms or complications associated with this event.The catheter was flushed as indicated in the ifu.Ancillary devices: sheath 8f cordis, guide catheter navien, guidewire synchro14 additional information was received stating that the cause of resistance was a quality problem with the spring coil microcatheter.The reason for the subsequent complaint about the spring coil was that the push bar was kinked, when it was opened, and was not pushed out of the sheath.
Additional Manufacturer Narrative
Equipment used: vis (m-78210), 203cm ruler (m-83361), pin gauge sets (m-84082, m-84080) document used: dwgs105-5091-150 rev.Ba, d00333843 rev.J, 50796doc1 rev.C as found condition (condition of returned device): an axium prime coil and an echelon-10 micro catheter were returned for analysis within a shipping box; within individually sealed biohazard pouches; and within individual dispenser tracks.Visual inspection/damage location details: (pli-10) the echelon-10 total length was measured to be ~156.7cm.The echelon-10 useable length was measured to be ~148.8cm which is within specification.Upon visual examination, no issues were found with the echelon-10 hub, body or distal tip.The distal tip was noted to be pre-shaped.No other anomalies were observed.(pli-20) the axium implant coil was returned within the introducer sheath.The axium implant coil pushwire was found to be broken but retained at ~6.3cm from proximal end.The axium prime coil was found to be detached and returned within introducer sheath.The axium implant coil was found to be stretched.The implant coil was not able to be pushed out from introducer sheath for further analysis as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): (pli-10) the echelon-10 micro catheter was flushed, water exited from the distal tip.One in house silverspeed-14 guidewire was able to enter and pass through the echelon-10 micro catheter hub without issue.(pli-20) the axium implant coil tip od (outer diameter) was measured to be 0.0117¿ which is within specifications.The id (inner diameter) of the introducer sheath was measured to be 0.0175¿ which is within specifications.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed; however, the root cause was unable to be determined.The customer reported preparing the axium implant coil as indicated in the ifu prior to use.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance at hub¿ could not be confirmed, and the root cause could not be determined.No damages were found with the returned echelon-10 micro catheter that would have contributed to the reported resistance.In addition, an in-house silverspeed-14 guidewire was able to enter and pass through the echelon hub without issue.Possible contributing factor to ¿catheter resistance at hub¿ is coil damage.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink¿ was confirmed.Pushwire damage can occur if the user advances the device against resistance.However, there was not any friction or difficulty during testing or delivery.Therefore, the cause for the pushwire kink could not be confirmed.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium implant coil instructions for use (ifu): ¿axium implant detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium implant coil and can therefore, be ruled out as a potential cause.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.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 HLX
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19167201
• Report Number: 9612164-2024-01948
• Device Sequence Number: 7873699
• Product Code: KRD
• UDI-Device Identifier: 00847536020917
• UDI-Public: 00847536020917
• 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): 05/15/2024

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: 07/06/2026
• Device Model Number: APB-1-2-HX-ES
• Device Catalogue Number: APB-1-2-HX-ES
• Device Lot Number: 226915180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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: 53 YR
• Patient Sex: Male