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

Catalog Number	21AHPJ-505
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event of explant due to valve leaflet found stuck in open position after three days of implant and high pressure gradient was reported.It was reported that normal leaflet function was confirmed manually with the leaflet tester after the suturing the valve.Information from field indicated that the valve was explanted and 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.A more comprehensive assessment, including hydrodynamic testing to evaluate valve function could not be performed as the device 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.Correction: h1 - type of reportable event.
Event or Problem 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.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm sjm masters series hemodynamic plus valve was chosen for implant.It was noted that the valve leaflet does not open consistently.The device was explanted and replaced with another sjm valve.
Additional Manufacturer Narrative
An event of explant due to valve leaflet found stuck in open position after three days of implant and high pressure gradient was reported.It was reported that normal leaflet function was confirmed manually with the leaflet tester after the suturing the valve.Information from field indicated that the valve was explanted and 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.A more comprehensive assessment, including hydrodynamic testing to evaluate valve function could not be performed as the device 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.H6 health effect - clinical code: 4582 was removed.
Event or Problem 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.
Additional Manufacturer Narrative
An event of explant due to valve leaflet found stuck in open position after three days of implant and high pressure gradient was reported.It was reported that normal leaflet function was confirmed manually with the leaflet tester after the suturing the valve.Information from field indicated that the valve was explanted and 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.Morphological and hydrodynamic examination indicated the valve met abbott 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEMODYNAMIC PLUS VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18007722
• Report Number: 2135147-2023-04650
• Device Sequence Number: 18040712
• Product Code: LWQ
• UDI-Device Identifier: 05415067043597
• UDI-Public: (01)05415067043597(17)280603(10)C00012761
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 21AHPJ-505
• Device Lot Number: C00012761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 02/13/2024; 04/09/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/16/2024; 02/14/2024; 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male