MAUDE Adverse Event Report: MEDTRONIC MEXICO AVALUS ULTRA BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	400U19
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the tear-away seal was received intact.The outer packaging showed a large indentation on one of the side panels.Upon opening the outer packaging, the contents (patient registration form, envelope and inserts) were found stiff with signs of amber stains suggestive of dried glutaraldehyde.The jar was found broken.Both safety seals on the jar were broken.Large cracks were noted on the lid.Multiple cracks were observed on the jar appearing to possibly be from the impact on the lid.Cracks were also noted at the bottom of the jar.No solution was present inside the jar.The avalus valve was found dry, inside its retainer.Shards of glass were found inside the packaging box.Updated data: d.9: suspect medical device h.6: coding 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.
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
It was reported that an avalus aortic valve was found to have a jar leak.The jar was cracked.There was no patient involvement.It was mentioned that it is unknown if the jar was dropped or if it was broken during delivery.The device was inspected prior to use,and it was never implanted.
Additional Manufacturer Narrative
Conclusion: the analysis and investigation is in progress.A supplemental report will be submitted after completion.B5, d9, e and h6 updated 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 was received that the valve was stored a regular secure valve closet and the jar was found to have a leak after being in storage for a while.There was no patient involvement.

• Brand Name: AVALUS ULTRA BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• 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: 21262122
• Report Number: 9612164-2025-00467
• Device Sequence Number: 9539005
• Product Code: DYE
• UDI-Device Identifier: 00763000647025
• UDI-Public: 00763000647025
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170006
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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 Model Number: 400U19
• Device Catalogue Number: 400U19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 05/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/28/2025; 05/19/2025
• Date Device Manufactured: 07/09/2024
• 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