MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM24

Device Problem Incomplete Coaptation (2507)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 24mm mitral mechanical valve, it was explanted and replaced with a 27mm non-medtronic bioprosthetic valve.The reason for the replacement was reported to be due to the two leaflets being unable to fully close resulting in severe regurgitation.It was also stated that upon opening, one of the valve leaflets was observed to be "a little sunken".The valve motion was not tested with the blue actuator.Tt was reported leaflet movement was normal and no impingement was noted.No additional adverse patient effects were reported.

• Brand Name: OPEN PIVOT AP360 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: 14479047
• MDR Text Key: 292489183
• Report Number: 3008592544-2022-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DM24
• Device Catalogue Number: 505DM24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female