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

Model Number	APB-2-6-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Medtronic received a report that the axium coil would not detach.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right clinoid segment with a max diameter of 6 mm and a 4 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the patient was undergoing an aneurysm coil embolization.After the spring coil was pushed, pull the spring coil detachment wire out of the planed detachment spring coil.However, when the push rod was pulled back, it was found that the spring coil was not detached successfully.It was considered that the detachment wire was broken at a certain section of the push rod and the spring coil could not be detached.Finally, used hemostatic forceps to clamp the clamping push rod at the possible fracture location, slowly retrieved the spring coil back to the microcatheter, and withdrew it from the body.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.
Event or Problem Description
Additional information was received stating that the actions/interventions that were taken to resolve the axium coil non-detachment included trying multiple times to pull out, take off silk, and get rid of it.The procedure was completed by withdrawing the axium coil and microcatheter and re-operated with microcatheter.The instant detacher was not used and the manual method was attempted 2 times.Prior to the coil non-detachment, there were no issues encountered.No pushwire damage was observed after removal from the p atient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H3: product analysis of apb-2-6-hx-es, lotno:226556154 visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube.There were no evidence of detachment attempts with an instant detacher at this location.The break indicator was found broken at the break indicator with the release wire fully retracted out of the pusher.This is indicative of a manual detachment attempt at this location.No damages or irregularities were found with the remaining pusher.The coin was found fully out of the lumen stop.The coin was found undamaged.The implant coil was found still attached to the pusher.The implant coil was found to be stretched and damaged with the polypropylene filament unbroken.The lumen stop was found damaged (ovalized).Testing/analysis ¿the axium prime implant coil was pulled distally, and the implant detached against high resistance.Unknown fibers were found within the retainer ring and on the detach element stick (figure l).The coin was measured to be ~0.088mm @ 0.063mm, ~0.093mm @ 0.127mm, and ~0.095mm @ 0.275mm, which is within specification (specification: 0.063mm ¿ 0.089mm @ 0.063mm; 0.075mm ¿ 0.105mm @ 0.127mm; and 0.086mm ¿ 0.108 @ 0.275mm).The inner diameter of the lumen stop could not be reliably measured due to the damaged condition.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.The likely cause of the non-detachment is likely to be the fibers found on the detach element and within the retainer ring, causing the detach element to become stuck within the retainer ring.Customer did not report any other devices used during the event and manufacturing process does not use any materials with similar fibers.Therefore, the source of the fibers could not be determined.The lumen stop was found damaged (ovalized), indicative that the coin was jammed within the inner diameter of the lumen stop, possibly contributing towards the implant to fail to detach.The cause of the coin stuck within lumen stop could not be confirmed.However, the device was returned with the coin already fully retracted out of the lumen stop with the implant still attached; therefore, this is not likely to be the primary cause of the non-detachment.The implant coil was found stretched/damaged.Possible causes include, but not limited to, lack of hydration before procedure, continuous flush not performed during procedure (or insufficient continuous flush), tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances/retracts the coil against resistance or incompatible catheter.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment could not be determined.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: 18640476
• Report Number: 9612164-2024-00585
• Device Sequence Number: 15470616
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2024

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: 06/09/2026
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 226556154
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 04/11/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/14/2024; 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: 47 YR
• Patient Sex: Female