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

Model Number	17AHPJ-505
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (b)(6) 2023, a 17mm sjm masters series hemodynamic plus valve was selected for procedure.The valve had been sized using a 905 mechinical heart valve sizer set.It was noted during procedure that the leaflet of the valve fractured into two pieces when rotating the valve.It was noted that the valve was unable to be rotated when the leaflet fractured.All the pieces were successfully recovered/removed from the patient.No other instruments encountered the valve at the time of fracture.The holder handle had been fully inserted into the orifice at a 90 degree angle.The valve was in a closed position when attempting to rotate it and the leaflet fractured.The decision was made to replace the 17mm sjm masters series hemodynamic plus valve with a 19mm sjm masters series valve expanded cuff to complete the procedure.The patient was not taken off bypass and placed back on bypass due to this event.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was fractured and dislodged from the orifice.No other damage was noted to the returned valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet or orifice damage.The damage may have been caused by some external force applied to the valve, which overstressed the carbon material.Please note, per the masters valve instructions for use, "valve rotation: using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".

• 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: 16981415
• Report Number: 2135147-2023-02256
• Device Sequence Number: 6800947
• Product Code: LWQ
• UDI-Device Identifier: 05414734005821
• UDI-Public: 05414734005821
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 07/27/2023

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 Expiration Date: 04/22/2025
• Device Model Number: 17AHPJ-505
• Device Catalogue Number: 17AHPJ-505
• Device Lot Number: 7491986
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2020
• 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: Male