MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	310C31
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unknown compound was discovered on the outside of a mosaic mitral valve jar.The device was never implanted.It was further reported that the unknown compound was only present on the outside of the jar.The valve was stored in a cabinet with temperatures approximately 51-61 degrees.It was stated that there was no leak on the valve jar and the device remained sterile.No other valves stored in this area had this issue.There was no patient involvement reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that there was no evidence of damages to the outside of the packaging.Upon opening the outer packaging, dried crystallized glutaraldehyde was noted on the inside of the box¿s back panel.Manufacturing quality engineering, manufacturing engineering and post market engineering with post market technician evaluated the return device.The jar was removed from the box.Both yellow safety seals were intact.With seals intact, the solution level was noted to be approximately below the half-filled mark.The reported ¿unknown compound¿ was observed on the outside of the jar.The label on the jar showed grooves suggestive of a glutaraldehyde leak.The jar was opened for further evaluation.A long crack was found on the inside of the jar, aligning to where the reported ¿unknown compound¿ was identified.The ¿unknown compound¿ appeared to be dried, crystallized glutaraldehyde.The dried glutaraldehyde on the jar threads was cleaned with isopropyl alcohol, cracks were further confirmed on the jar threads.Under magnification, the cracks were noted along the length of the jar, extending from the jar threads to the bottom of the jar.The ¿unknown compound¿ was found to be dried glutaraldehyde resulting from the cracks on the jar.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: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: REPLACEMENT HEART-VALVE
• 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: 22242544
• Report Number: 2025587-2025-04287
• Device Sequence Number: 8177173
• Product Code: DYE
• UDI-Device Identifier: 00643169594869
• UDI-Public: 00643169594869
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P990064
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 03/31/2026
• Device Model Number: 310C31
• Device Catalogue Number: 310C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Sex: Unknown