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

Model Number	17AHPJ-505
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, a 17mm sjm masters series hemodynamic plus valve was selected for implant in an intra-annular aortic placement via aortotomy.Once implanted the valve was implanted, the physician took a plastic tip to check leaflet mobility.It was shown using transesophageal echocardiogram (tee) that the leaflets were not properly coapting due to an obstruction of the leaflets.The valve was not rotated.The valve was explanted and replaced with another 17mm sjm masters series hemodynamic plus valve.Another tee was performed, and the replacement valve was shown to be functioning normally.The aortotomy was closed an the procedure concluded without further incident.Significant past medical history includes a small, heavily calcified aortic root and tubular aorta.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient has been discharged.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of leaflets were not properly coapting was reported.The investigation found that both leaflets opened and closed completely and were freely mobile.No anomalies or damages were noted to the valve.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 leaflets not coapting properly could not be conclusively determined, however is consistent with patient anatomy.
Event or Problem Description
It was reported that on (b)(6) 2022, a 17mm sjm masters series hemodynamic plus valve was selected for implant in an intra-annular aortic placement via aortotomy.Once implanted the valve was implanted, the physician took a plastic tip to check leaflet mobility.It was shown using transesophageal echocardiogram (tee) that the leaflets were not properly coapting due to an obstruction of the leaflets.This immobility was reported as being due to subvalvular substructures interfering with the device.The valve was not rotated.The valve was explanted and replaced with another 17mm sjm masters series hemodynamic plus valve.Another tee was performed, and the replacement valve was shown to be functioning normally.The aortotomy was closed an the procedure concluded without further incident.Significant past medical history includes a small, heavily calcified aortic root and tubular aorta.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient has been discharged.No additional information was provided.

• 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): 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: 15620964
• Report Number: 2135147-2022-01672
• Device Sequence Number: 20379411
• Product Code: LWQ
• UDI-Device Identifier: 05414734005821
• UDI-Public: 05414734005821
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 17AHPJ-505
• Device Catalogue Number: 17AHPJ-505
• Device Lot Number: C00001349
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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
• Patient Sex: Female