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

Model Number	APB-2.5-6-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	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil encountered resistance in the catheter and the push wire was kinked.The patient was undergoing coil embolization for treatment of a saccular, unruptured aneurysm in the anterior communicating artery ( acom) with a max diameter of 4.8 mm and a 1.6 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that patient has a normal bp level with moderate vessel tortuosity.The sheath, guide catheter and micro catheter was parked appropriately.First coil was deployed and second ev3 coil (apb-2.5-6-hx-es lot 226870613) coil was taken.Physician has started experiencing resistance while advancing the coil into the microcatheter and pusher wire was kinked.Coil was resheathed and competitor coil was deployed.It was reported the pusher was kinked/broken.There was friction or difficulty during testing or delivery.The continuous flush administered during the procedure.The damage was located in the push wire middle segment.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.Ancillary devices include a neuron max sheath, navien 5f guide catheter, excelsior sl 10 microcatheter, traxcess 14 guidewire.Additional information was received that the cause of the push wire kink was not determined.Resistance occurred in the proximal section of the catheter.The coil came out of the introducer sheath smoothly and there were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
H3: product analysis of apb-2.5-6-hx-es, lotno:226870613 found the axium prime coil pushwire bent within introducer sheath at ~105.8cm from proximal end.The implant coil was already detached.All other subassemblies appeared to be normal, and no other anomalies were observed.The axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.Based on the device analysis and the reported information, the customer¿s report of ¿pusher kink/damage¿ was confirmed as the axium pusher was bent; however, the cause of the damage/stretch could not be determined.Possible causes are coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances or retracts the coil against resistance.There were no reported issues pushing the axium implant coil from within the introducer sheath during preparation per i fu.It is possible the implant coil pushwire became damaged when inserting into micro catheter or due to improper hubbing technique (over tightening of the rhv) subsequently causing the implant coil to become stuck.The non-medtronic micro catheter (sl-10 stryker) used in the event was not returned.The inner diameter (id) of the sl 10 microcatheter was found to be 0.0165¿ (per an online source) per axium prime coil instructions for use (ifu): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands.¿.Therefore, the sl 10 micro catheter was found to be compatible for use with the axium prime coil and can be ruled out as a potential cause.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 18920259
• Report Number: 9612164-2024-01299
• Device Sequence Number: 15003030
• Product Code: KRD
• UDI-Device Identifier: 00847536021051
• UDI-Public: 00847536021051
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 03/18/2024

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: 06/28/2026
• Device Model Number: APB-2.5-6-HX-ES
• Device Catalogue Number: APB-2.5-6-HX-ES
• Device Lot Number: 226870613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: 42 YR
• Patient Sex: Female