MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1-3-3D-ES
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Therapy Delivered to Incorrect Body Area (1508); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of apb-1-3-3d-es, lot#226181856 as found condition: the axium prime coil was returned for analysis within two shipping boxes; within an opened axium prime outer carton; within an opened axium prime inner pouch; within a dispenser coil; and within an introducer sheath.The unknown non-medtronic micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath or axium prime pusher.The axium prime implant coil was found to be slightly damaged.The coil shape was confirmed to be a 3d model.Testing/analysis: the axium prime coil was advanced out of the introducer with no resistance encountered.The implant coil was confi rmed slightly damaged.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿difficult placement/positioning¿, ¿coil loop in parent vessel¿ and ¿coil deployed at incorrect location¿ could not be confirmed through device analysis and the customer did not submit any videos or pictures for review.Possible causes for these failures are vessel tortuosity, catheter tip under stress, catheter placement or catheter kickback.Customer reported the device did not jump during deployment tip of the catheter was not under stress, the tip of the catheter did not move during deployment, devices were prepared per ifu, and vessel tortuosity as moderate.Therefore, the likely cause could not be determined.The implant coil was found slightly damaged, potentially contributing to the three failures.However, it is possible that the damages occurred due to manipulation against the difficulty navigation.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
Medtronic received a report that the physician was treating a bizarre shaped anterior communicating artery  aneurysm in which de decided to do pipeline vantage fd assisted coiling.After deploying fd and two coils in this aneurysm, this coil was coming out from the aneurysm even after trying many times.So physician decided to take out this coil and did not deploy more coils.There was difficult placement.The coil was not implanted at the intended location.No additional steps or surgical intervention was required to remove or secure the coil.The device did not jump during deployment.The vessel was not damaged.The tip of the catheter was not under stress.The tip of the catheter did not move during deployment.The aneurysm did not rupture.The device and any accessories were prepared as indicated in the ifu.  no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, ruptured anterior communicating artery aneurysm with a max diameter of 3.4mm and a 2.9mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.

• Brand Name: AXIUM PRIME BRPL 3D
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19354378
• Report Number: 9612164-2024-02406
• Device Sequence Number: 7724507
• Product Code: KRD
• UDI-Device Identifier: 00847536021129
• UDI-Public: 00847536021129
• 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,Followup
• Report Date (Section B): 08/05/2024

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: 03/21/2026
• Device Model Number: APB-1-3-3D-ES
• Device Catalogue Number: APB-1-3-3D-ES
• Device Lot Number: 226181856
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: 52 YR
• Patient Sex: Female