MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM27

Device Problems Incomplete Coaptation (2507); Central Regurgitation (4068)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/06/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 27mm mitral mechanical valve, it was explanted and replaced with a 29mm mechanical valve of the same model.The reason for the replacement was reported as one of the valve leaflets not functioning correctly.Information was provided that when the patient went off bypass the first transesophageal echocardiograph (tee) showed severe mitral regurgitation and posterior jet.The patient went back on bypass to test for paravalvular leaks.None were found, valve showed proper coaptation, 1-3 stiches were added to reinforce the posterior, the patient went off bypass.A second tee was done and demonstrated the same findings as before.The patient went back on bypass again the valve was tested again and a third tee revealed that one of the leaflets was not function correctly.The leaflet motion of the mechanical valve was tested with the blue actuator during the implant procedure.The mechanical valve was not rotated within the annulus in attempt to obtain appropriate leaflet motion.It was also stated that the size change was due to "no other size 27 mm was available," the implanting physician " had to implant 29 mm and removed the native posterior leaflet".No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve appeared discolored showing evidence of blood contact.Both leaflets appeared intact.No cracks or fractures were observed.Both leaflets were received in the closed position.The blue actuator was used to test leaflet mobility.The leaflets moved without difficulty.The orifice appeared intact; there was no evidence of damage.Both inflow and outflow valve hinge mechanisms appeared intact; there was no evidence of damage.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.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: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis,mn CA 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis,mn CA 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18257391
• MDR Text Key: 329616311
• Report Number: 3008592544-2023-00106
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: 500DM27
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Date Device Manufactured: 10/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 85 KG