MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-6-20-3D-SS
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
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
Medtronic received a report that the axium coil could not be detached.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right internal carotid artery 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 opened the package, hydrated, delivered the spring coil, and after it was in place, found that it could not be detached.Withdrew and replaced.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.
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 that the cause of the coil non-detachment was not determined.More than 3 attempts were made to detach the coil using the instant detacher.Two attempts were made to detach the coil using the manual method.Prior to coil non-detachment, there were no issues encountered.There was not any pushwire damage observed after removal from the patient.
Additional Manufacturer Narrative
Product analysis # (b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium prime device was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.The implant coil was already detached and returned within the same plastic biohazard pouch.The instant detacher used during the event was not returned for analysis.Visual inspection/damage location details: the break indicator was found kinked and broken.The proximal segment (including the actuator interface) was not returned for analysis (figure c).This break is indicative of a manual detachment attempt.The coin and release wire were fully retracted out of the lumen stop/pusher and not returned for analysis.The shield coil was found stretched.The already detached implant coil was found stretched and damaged with the polypropylene filament retracted within the damaged implant.No damages were found with the lumen stop.Dried blood was found within the lumen stop.No damages or irregularities were found with the detach element or detach element ball.Testing/analysis ¿ the lumen stop inner diameter was measured to be 0.0029¿, which is within specification (specification: 0.00220¿ ¿ 0.0029¿).The detach element ball outer diameter was measured to be 0.0038¿, which is within specification (specification: 0.0038¿ ± 0.00010¿).Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed as the device was returned with the implant already detached.However, the reported non-detachment could not be ruled out.Dried blood was found within the lumen stop, potentially contributing towards a non-detachment.The shield coil was found stretched.It is possible that the damaged shield coil became entangled with the proximal implant coil, causing the implant to not fully separate from the pusher during detachment attempts.Possible causes for shield coil stretching are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances against resistance, incompatible micro catheter, or damaged micro catheter.The likely cause could not be determined.The proximal pusher, release wire/coin, and instant detacher used in the event was not returned for analysis.Therefore, any contribution of the subassemblies and instant detacher towards the non-detachment and conformance to specification 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 3D
• 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 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19624182
• Report Number: 9612164-2024-03030
• Device Sequence Number: 17732315
• Product Code: KRD
• UDI-Device Identifier: 00847536008281
• UDI-Public: 00847536008281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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,Followup,Followup
• Report Date (Section B): 09/09/2024

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 Model Number: APB-6-20-3D-SS
• Device Catalogue Number: APB-6-20-3D-SS
• Device Lot Number: 227852234
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided; 08/13/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: 64 YR
• Patient Sex: Male