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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil did not detach.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the middle cerebral artery bifurcation with a max diameter of 5 mm and a 3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that stent-assisted coil embolization was performed to treat intracranial aneurysm.After the coil embolization catheter was in place, a 3-6 axium prime was delivered.After delivery, the coil was detached, but it did not detach.The alternate detachment point was tried again, but it still did not detach.The coil was withdrawn as a whole, replaced with a new one, and the subsequent embolization work was completed.The reported device and any accessory devices were prepared as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.
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 one detachment attempt had been made each with the instant detacher and the manual method.There had been no issues encountered prior to the non-detachment, and no damage to the pushwire was observed.The cause of the non-detachment was not determined.
Additional Manufacturer Narrative
Product analysis #706781613:equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): an axium prime coil was returned within a shipping box; within a plastic sealed biohazard pouch and within a resealable plastic bag.The axium prime coil was returned without the introducer sheath.Visual inspection/damage location details: the axium prime coil was returned without the introducer sheath.The axium pushwire was found to be broken at proximal end between load indicator and break indicator.There appeared to be evidence of manual detachment at this location.The pushwire was found to be kinked at ~138.5cm from proximal broken end.The coin was found completely pulled out of pushwire assembly.The shield coil was found intact with the implant coil still attached.The implant coil was found to be stretched and damaged.No other anomalies were observed.Testing/analysis (including sem reports): the distal outer jacket was removed for additional analysis.The lumen stop appeared to be visually acceptable.The detach element was found to be stuck within retainer ring and was unable to be removed.The coin and release tip wire appeared to be visually acceptable conclusion: based on the analysis performed, the customer report of ¿non-detachment¿ was confirmed.Possible causes for non-detach are damaged pusher, coin jammed at lumen stop, coil shield wrapped around coil shell or proximal end of implant coil or actuator interface bent or actuator interface extension distance out of specification.It is likely the detach element becoming stuck within retainer ring contributed to non-detachment.The kink found on the returned pusher is indicative of high tortuosity.It is possible the kinks found on the pushwire may have contributed to the non-detachment as it would increase resistance when the release wire and coin is being pulled away from the lumen stop.The root cause 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; 9775 toledo way; irvine CA 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; 9775 toledo way; irvine CA 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19761248
• Report Number: 9612164-2024-03284
• Device Sequence Number: 15634695
• Product Code: KRD
• UDI-Device Identifier: 00763000313739
• UDI-Public: 00763000313739
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• 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): 09/24/2024

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-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: 227626106
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 08/29/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2023
• 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 Sex: Unknown