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

Model Number	T510C27
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.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.
Event or Problem Description
Medtronic received information that 3 years and 7 months post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic valve.The reason for the replacement was reported as positioning/advancement issues and left ventricular outflow tract (lvot) obstruction.It was stated that the 27mm aortic bioprosthetic valve was not positioned correctly during initial implant.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the valve is slightly distorted; oval shaped.Stent measurements: 27.28 mm x 26.66 mm, stent post measurements: lr= 2°, rnc= -5°, ncl= 5°.All leaflets are in the closed position.All leaflets are flexible and intact.The free margins of the non-coronary cusp appear wavy possibly due to the slightly deflected right non-coronary and non-coronary left stent posts.All commissures are intact.Remnants of pannus are observed along the sewing ring on the inflow.Traces of pannus are observed on the outflow rail and tops of the non-coronary right and left right stent posts.An unknown number of pannus appears to have been removed from the inflow and outflow of the valve.Radiography shows no evidence of mineralization in the stent and/or remnants of host tissue.Radiography shows no evidence of fractures in the stent or st iffening ring.Updated data: 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.
Event or Problem Description
Medtronic received information that 3 years and 7 months post implant of this 27mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic valve.The reason for the replacement was reported as positioning/advancement issues and left ventricular outflow tract (lvot) obstruction.It was stated that the 27mm aortic bioprosthetic valve was not positioned correctly during initial implant.No additional adverse patient effects were reported.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• 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: 20397800
• Report Number: 2025587-2024-05563
• Device Sequence Number: 6518031
• Product Code: LWR
• UDI-Device Identifier: 00643169027084
• UDI-Public: 00643169027084
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 12/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2021
• Device Model Number: T510C27
• Device Catalogue Number: T510C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 12/23/2024
• Date Device Manufactured: 11/12/2018
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 81 KG