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

Model Number	APB-5-10-HX-SS
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda report code: 1294410352024000592.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 poor anchoring of the axium spring coil caused the spring coil to prolapse.The patient required coronary artery pulmonary artery fistula embolization due to congenital coronary artery pulmonary artery fistula.Due to the widened blood vessels and rapid blood flow, the coil dislodged from the coronary artery into the right lower pulmonary artery, which may lead to the risk of right lower pulmonary artery embolism in the later stage.The surgeon punctured the femoral vein to enter the pulmonary artery and successfully performed coil capture and removal.After the above treatment, the patient had no foreign objects in the body in an inappropriate position and no harm was caused to the patient.
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 this was the first time that the hospital's cardiovascular department used medtronic axium coils.Three coils were subsequently used, with specifications of 3-8, 3-8, and 3-10.The coil flew out because it was not properly coiled when forming hoop and it did not stretch automatically.The coil was removed on the day of the surgery.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 19634084
• Report Number: 9612164-2024-03042
• Device Sequence Number: 8610209
• Product Code: KRD
• UDI-Device Identifier: 00847536038561
• UDI-Public: 00847536038561
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2024
• Device Model Number: APB-5-10-HX-SS
• Device Catalogue Number: APB-5-10-HX-SS
• Device Lot Number: 223429931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/24/2024
• Date Device Manufactured: 12/04/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male