MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACCESSORY APU448 AORTIC PUNCH SHRT 4.8MM; HEART-VALVE, MECHANICAL

Model Number	APU448
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2026
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
Medtronic received information that prior to using two 4.8mm apu448 aortic punch, it was reported that the surgeon stated, "the punches were changed without physician's knowledge or consent, these punches are "almost dangerous", they are blunt, rough going in, tear the aorta, too short, and likely to cause micro-dissections.Not a suitable product.".No additional adverse patient effects were reported.

• Brand Name: ACCESSORY APU448 AORTIC PUNCH SHRT 4.8MM
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25170128
• Report Number: 9617601-2026-03116
• Device Sequence Number: 18783241
• Product Code: LWQ
• UDI-Device Identifier: 00763000122157
• UDI-Public: (01)00763000122157(17)271013(10)232461448
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: APU448
• Device Catalogue Number: APU448
• Device Lot Number: 232461448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 05/27/2026
• Date Device Manufactured: 10/13/2025
• 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