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

Catalog Number 21AHPJ-505

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Endocarditis (1834)

Event Date 09/12/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, a 21mm sjm masters series hemodynamic plus valve was chosen for implant.After the valve was sutured in, normal leaflet function was confirmed manually with the official leaflet tester.After procedure, the patient passed a smooth post-operative course.Three days post-procedure, it was observed during pre-discharge transthoracic echocardiography (tte) the valve leaflet was stuck in open position.This was confirmed the next day on transesophageal echocardiography (tee).It was noted that the pressure gradient was high, which was believed to be due to the implanted valve.A decision was made to explant the valve on 16 september 2023 and replaced with another 21mm sjm masters series hemodynamic plus valve.The explanted valve was tested again for leaflet function and found to move normally with the leaflet tester but after a few minutes the leaflet was stuck again and needed the leaflet tester to push.The patient remained hemodynamically stable throughout the procedure.The patient status was reported as discharged.It was later reported on an unknown date, the patient presented with infective endocarditis on the second 21mm sjm masters series hemodynamic plus valve.The patient was reported to have undergone a homograft procedure on an unknown date.

Manufacturer Narrative

An event of infective endocarditis 10 days post-procedure was reported.A more comprehensive assessment, including histopathological examination to evaluate valve function could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the potential cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 21mm sjm masters series hemodynamic plus valve was chosen for implant.After the valve was sutured in, normal leaflet function was confirmed manually with the official leaflet tester.After procedure, the patient passed a smooth post-operative course.Three days post-procedure, it was observed during pre-discharge transthoracic echocardiography (tte) the valve leaflet was stuck in open position.This was confirmed the next day on transesophageal echocardiography (tee).It was noted that the pressure gradient was high, which was believed to be due to the implanted valve.A decision was made to explant the valve on (b)(6) 2023 and replaced with another 21mm sjm masters series hemodynamic plus valve.The explanted valve was tested again for leaflet function and found to move normally with the leaflet tester but after a few minutes the leaflet was stuck again and needed the leaflet tester to push.The patient remained hemodynamically stable throughout the procedure.The patient status was reported as discharged.10 days post-procedure, the patient presented with infective endocarditis on the second 21mm sjm masters series hemodynamic plus valve.The patient was reported to have undergone a homograft procedure in (b)(6) 2023.It was indicated that the homograft was not related to implanted 21mm mechanical valve.The patient was reported to be stable.

• Brand Name: MASTERS SERIES HEMODYNAMIC PLUS 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: 18288660
• MDR Text Key: 329994175
• Report Number: 2135147-2023-05386
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: MU
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21AHPJ-505
• Device Lot Number: C00002411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2022
• 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: 24 YR
• Patient Sex: Male