MAUDE Adverse Event Report: MEDTRONIC MEXICO ACCESSORY APU444 AORTIC PUNCH SHRT 4.4MM; HEART-VALVE, MECHANICAL

Model Number	APU444
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of this 4.4mm accessory device, it was reported that "a customer tray cardio vascular pack" with an expiration date of may 2025 was being used and on examination, it was observed that one of the devices from the box had an expiration date of january 2025.It was stated that two devices of this lot with an expiration date of may 2025 are still in stock.No patient involvement was reported.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
B5: corrected.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 information that prior to use of a custom tray cardiovascular pack put together by the facility, containing this 4.4mm aortic punch accessory device, it was observed on product packaging that the device had an expiration date of january 2025.The custom tray was labeled with an expiration date of may 2025 along with other similar aortic punch accessory devices.It was stated that two devices of this lot with an expiration date of may 2025 are still in stock.No patient involvement was reported.

• Brand Name: ACCESSORY APU444 AORTIC PUNCH SHRT 4.4MM
• Common Device Name: HEART-VALVE, MECHANICAL
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21642364
• Report Number: 9612164-2025-01402
• Device Sequence Number: 7564665
• Product Code: DWS
• UDI-Device Identifier: 00763000122140
• UDI-Public: 00763000122140
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: 05/19/2025
• Device Model Number: APU444
• Device Catalogue Number: APU444
• Device Lot Number: 226618778
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 05/19/2023
• 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