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

Model Number	25AHPJ-505
Medical Device Problem Codes	Fracture (1260); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
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) 2022, a 25mm sjm masters series hemodynamic plus valve was selected for procedure.During the procedure, the valve was attempted to insert in the aortic position through a woven dacron's tube.It was attempted to push on the valve with the support handle but this was unsuccessful due to friction and the support handle was removed.It was then attempted to use dissection forceps to push on the cuff to position the device in the patient's annulus but this was unsuccessful.A leaflet was fractured and the other leaflet dislodged and traveled to the patient's left ventricle.The dislodged leaflet and fractured leaflet were both removed from the patient as one single piece the a 25mm sjm masters series hemodynamic plus valve was not in the fully closed position when being rotated, but no resistance was noted when rotating the valve.The holder handle had been fully inserted into the valve's orifice at a 90 degree angle.The decision was made to remove the 25mm sjm masters series hemodynamic plus valve and replace it with a 25mm sjm masters series mechanical heart valve to complete the procedure.The replacement valve was implanted successfully.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay during procedure.Post procedure, the patient had left ventricular failure in the immediate postoperative period and was placed on extracorporeal membranous oxygenation (ecmo) support.The patient was not on ecmo prior to or during procedure.The patient was noted as being stable prior to procedure, but had been previously diagnosed with aortic stenosis.There was no noted damage to the patient's left ventricle or other heart structures/tissues caused by the dislodged/fractured leaflet pieces.The patient was noted to have regained cardiac function.The patient was doing well and recovering at the time of report.The direct cause of patient's left ventricular failure is unknown.
Additional Manufacturer Narrative
The reported event of a dislodged leaflet was confirmed.One leaflet was fractured and the other was dislodged from the orifice.In addition, two of the recessed pivot areas were chipped.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the valve was being pushed on the cuff with dissection forceps at the time of the leaflet dislodging, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use "to minimize direct handling of the valve during implantation, do not remove the holder/rotator until the valve has been seated in the annulus.".

• 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: 15676132
• Report Number: 2135147-2022-01809
• Device Sequence Number: 6496837
• Product Code: LWQ
• UDI-Device Identifier: 05414734006293
• UDI-Public: 05414734006293
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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 Expiration Date: 05/05/2026
• Device Model Number: 25AHPJ-505
• Device Catalogue Number: 25AHPJ-505
• Device Lot Number: 7960064
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male