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

Catalog Number	25AJ-501
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Respiratory Insufficiency (4462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 12 july 2024, a 25mm sjm masters series mechanical heart valve was chosen for implant.The valve was implanted, and it was noted that one leaflet did not move.The valve was explanted and replaced with a 27mm sjm masters series mechanical heart valve.There were no adverse patient effects were reported.The patient was reported as stable.
Event or Problem Description
It was reported that on (b)(6) 2024, a 25mm sjm masters series mechanical heart valve was chosen for implant.During device preparation, the leaflet movement was tested by abbott soft pen, and leaflets were moving normally when tested.The valve was implanted, and it was noted that one leaflet did not move.The valve was explanted and replaced with a 27mm sjm masters series mechanical heart valve.After the explant, the leaflet was moving properly when tested.The patient remained hemodynamically stable throughout the procedure.The patient required longer intermediate surgical unit (isu) stay due to respiratory failure.The patient was reported as stable.
Additional Manufacturer Narrative
Additional information was received that the patient experienced a serious injury.
Additional Manufacturer Narrative
An event abnormal opening and closing of the valve leaflets after implantation was reported.It was indicated that the leaflets moved normally when tested during device preparation and that after explant the leaflets were moving normally.The functional testing confirmed that hydrodynamic parameters of effective orifice area and regurgitation fraction met the product requirements.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.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.
Event or Problem Description
It was reported that on (b)(6) 2024, a 25mm sjm masters series mechanical heart valve was chosen for implant.During device preparation, the leaflet movement was tested by abbott soft pen, and leaflets were moving normally when tested.The valve was implanted, and it was noted that one leaflet did not move.The valve was explanted and replaced with a 27mm sjm masters series mechanical heart valve.After the explant, the leaflet was moving properly when tested.The patient remained hemodynamically stable throughout the procedure.The patient required longer intermediate surgical unit (isu) stay due to respiratory failure.The patient was reported as stable.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: 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: 19950591
• Report Number: 2135147-2024-03883
• Device Sequence Number: 13003588
• Product Code: LWQ
• UDI-Device Identifier: 05415067043054
• UDI-Public: (01)05415067043054(17)290317(10)C00019759
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 09/27/2024

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: 25AJ-501
• Device Lot Number: C00019759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/25/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/20/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• 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: Hospitalization
• Patient Sex: Male