MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number AJ-501

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on (b)(6) 2023, a 25mm master's standard a ortic was implanted in a patient with a history of severe aortic stenosis.At the time of device preparation, the leaflets was moving normally when tested.10days after the valve was successfully implanted, the physician found that the opening and closing of the valve leaflets was restricted by ultrasonography, and regurgitation occurred.On (b)(6) 2023, device was explanted and a new 25mm master's standard a ortic was implanted as a replacement that successfully completed the procedure.The patient was given warfarin and aspirin as antithrombotic medication with an international normalized ratio (inr) of 2.3.The patient was in stable condition.

Manufacturer Narrative

An event of difficulty with valve opening and closing and regurgitation was reported.The valve was returned to abbott for investigation.The investigation confirmed no surface damage or anomalies.No tissue was noted anywhere on the device.Both leaflets were properly inserted within the orifice and did not contain any surface damage.Both leaflets were able to fully open and close with no resistance occurring.Morphological and hydrodynamic examinations indicated that the valve met abbott's specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17107659
• MDR Text Key: 317043678
• Report Number: 2135147-2023-02527
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• 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,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AJ-501
• Device Catalogue Number: 25AJ-501
• Device Lot Number: C00004948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG