MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id id-1-5 (lot: unknown).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.
Event or Problem Description
Medtronic received a report that the axium coil could not be detached with the instant detacher (id).The patient was undergoing treatment for aneurysm embolization.It was reported that the coil could not be "cut" using the id.The coil was collected and replaced without effect on the patient.There had been no abnormalities in the appearance of the package.The event was said to be not associated with the patient.The devices were prepared according to the instructions for use (ifu).
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.
Event or Problem Description
Additional information received reported that three detachment attempts were made with the instant detacher, and none were made with the manual method.There were no particular issues encountered prior to the non-detachment.No damage to the pushwire was observed.The patient had been undergoing treatment for an aneurysm located in the anterior communicating artery.The size was 6-7mm.The patient's vessel tortuosity was normal.
Additional Manufacturer Narrative
Product analysis #(b)(4):¿ equipment used: vis (m-85519) ¿ as found condition: the axium prime coil was returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: the axium prime pushers actuator interface (ai) was found detached from the coupler tube and bent.The axium prime pushers hypotube break indicator (hbi) was found intact.The release wire coil was found against the lumen stop and the implant coil was found still attached to the pusher.¿ testing/analysis: the axium prime pusher hbi was broken, and the release wire was pulled, detaching the implant coil.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿non-detachment¿ report was confirmed as the axium prime implant coil was found still attached to the pusher.However, the axium prime implant coil was successfully detached using the manual method.As the axium prime pushers' actuator interface (ai) was found detached, this indicates that a detachment attempt was made using the axium instant detacher (id).However, the id was not returned; therefore, an analysis could not be performed, and any contributing factors could not be assessed.The cause for the reported event 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 S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20231339
• Report Number: 9617601-2024-00181
• Device Sequence Number: 8517037
• Product Code: KRD
• UDI-Device Identifier: 00847536020948
• UDI-Public: 00847536020948
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2024

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: 04/04/2026
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: 226310759
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 10/30/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/03/2024; 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Sex: Unknown