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

Model Number	19AECJ-502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2023
Type of Reportable Event	Malfunction
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) 2023, a 19mm masters series valve expanded cuff was selected for an implant.The surgeon sized the aortic annulus with the help of 905 sizer set, while rotating the valve one of the leaflet found broken into two pieces and was recovered from the patient.Device was explanted, and a new 19mm masters series valve expanded cuff was implanted as a replacement.The patient is stable.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6, h10 an event of a leaflet being fractured during valve rotation was reported.The device was returned to abbott for investigation, and one leaflet had been fractured but was not dislodged from the orifice.The other leaflet remained intact.There was no resistance reported by the field during rotation of the valve.Information from the field indicated that the holder handle was fully inserted into the orifice at a 90 degree angle and no instruments encounter the valve at the time of fracture.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but the damage is consistent with force being exerted on the leaflet.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)2023, a 19mm masters series valve expanded cuff was selected for an implant.The surgeon sized the aortic annulus with the help of 905 sizer set, while rotating the valve one of the leaflet found broken into two pieces and was recovered from the patient.Device was explanted, and a new 19mm masters series valve expanded cuff was implanted as a replacement.The patient is stable.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• 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: 16943711
• Report Number: 2135147-2023-02142
• Device Sequence Number: 19428459
• Product Code: LWQ
• UDI-Device Identifier: 05414734053877
• UDI-Public: 05414734053877
• 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): 07/24/2023

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 Model Number: 19AECJ-502
• Device Catalogue Number: 19AECJ-502
• Device Lot Number: C00000172
• 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: 04/22/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: Unknown