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

Model Number 500DM27

Device Problem Central Regurgitation (4068)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/03/2024

Event Type  Injury  

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 Description

Medtronic received information that during the implant of this 27mm mitral mechanical valve, it was explanted and replaced with a valve of the same model and size.The reason for the replacement was reported as a moderate leakage was observed after implant near one of the valve leaflets.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated b5 updated d9 updated h6 updated h3 product analysis: the product has been returned and analysis is in progress 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 Description

Medtronic received additional information which stated that there were no leaflet restrictions during and after implantation.A transesophageal echocardiogram (toe) revealed a severe leakage due to one intermittent leaflet dysfunction.It was clarified that this dysfunction was not occurring with every heart beat.It was reported that during reoperation, no impingement was observed and rotation of the valve was attempted in the hope that this would resolve the issue.A second toe demonstrated that the issue had not been resolved and the valve was subsequently explanted and replaced.It was mentioned that after explantation, the valve was seen to have more mobility of one of the leaflets at the hinge.It was noted that leaflet motion was tested with the blue actuator during the implant procedure.It was mentioned that the native valve had been excised.It was reported that the physician believed that one of the leaflets had more movement than the other.No additional adverse patient effects were reported.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19143350
• MDR Text Key: 340596125
• Report Number: 3008592544-2024-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Date Device Manufactured: 07/09/2021
• 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: 51 YR
• Patient Sex: Female