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

Model Number	APB-1-1-HX-ES
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2024
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
Additional information was received that there was no damage or evidence of tamping to device packaging.The proximal end of the pushwire was secured in the guidewire clip when the package was opened.There was no kink/damage observed on the pushwire.
Event or Problem Description
Medtronic received a report that the coil was found broken upon opening the packaging.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the anterior communicating artery with a max diameter of 3mm and a 2.1mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that when the doctor was unsealing the product during surgery, they discovered that the coil was broken and suspected it to be a manufacturing defect.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with 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
Product analysis #811251861:equipment used: vis (m-78210), 203cm ruler (m-83360) as found condition (condition of returned device): the axium prime coil and was returned for analysis within a shipping box; within a sealed plastic bag and within dispenser track.The axium prime coil was returned within introducer sheath.Visual inspection/damage location details: the axium prime pushwire was found bent at ~0.9cm and broken but retained by release wire at ~3.5cm from the proximal end.The axium prime coil was found to be already detached within introducer sheath.The implant coil was found to be stretched and damaged.The implant coil was unable to be removed from introducer sheath as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): n/a conclusion: based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the coil was found to be detached and not separated/broken.Based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was confirmed as the pushwire was found to be returned damaged, not secured within the rubber stopper and without the dispenser coil and clip.It is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.(reyesr32 2024-09-17) 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 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: 19816741
• Report Number: 9612164-2024-03376
• Device Sequence Number: 8665453
• Product Code: KRD
• UDI-Device Identifier: 00763000313784
• UDI-Public: 00763000313784
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/14/2024

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-1-1-HX-ES
• Device Catalogue Number: APB-1-1-HX-ES
• Device Lot Number: 227719064
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 09/17/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/13/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• 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: 78 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG