MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	HC150-14
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
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 this 14mm pulmonary valved conduit had an activated temperature indicator.It was then confirmed that the device was implanted.The surgeon was informed prior to use of the device that the conduit should not be used if the temperature indicator is activated.Subsequently 8 days later, the valve was explanted.The reason for replacement was reported as the valve "was too big".It was reported that prior to use, the valve was stored in the operating room with constant temperature, on an open cart.It was stated that the operating room was thermostat controlled and the valve did not experience known extreme temperatures.It was noticed that the temperature indicator had been activated after being on the shelf for approximately 3 weeks and some other valves stored in the same location had indicators which started to activate but were not fully black.It was reported that the valves with temperature indicators which were not fully black, have been like that for awhile with no change and were on the self prior to the hancock.No additional adverse patient effects were reported.

• Brand Name: HANCOCK
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21708279
• Report Number: 2025587-2025-02160
• Device Sequence Number: 10072439
• Product Code: LWR
• UDI-Device Identifier: 00763000926472
• UDI-Public: 00763000926472
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 03/27/2025

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 Model Number: HC150-14
• Device Catalogue Number: HC150-14
• 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: 03/18/2025
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 09/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown