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

Model Number 25AHPJ-505

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 302471701
• Report Number: 2135147-2022-01809
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006293
• UDI-Public: 05414734006293
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male