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

Catalog Number	25MJ-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
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 25mm masters series mechanical heart valve was selected for an implant.During the procedure, at the time of installation it developed crumbling and broke.Device was replaced with an unknown device that completed the procedure.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2023, a 25mm masters series mechanical heart valve was selected for an implant.During the procedure, at the time of installation it developed crumbling and broke and was recovered from the patient.Device was replaced with an unknown device that completed the procedure.The patient is stable.
Additional Manufacturer Narrative
An event of leaflet fracture was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received the cause of the leaflet fracture could not be conclusively determined.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.
Additional Manufacturer Narrative
An event of leaflet dislodgement and fracture was reported.The investigation found that one leaflet was received intact while the other leaflet was dislodged and not returned.The orifice was undamaged.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 fracture 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.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES MECHANICAL HEART 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: 18014137
• Report Number: 2135147-2023-04705
• Device Sequence Number: 7478722
• Product Code: LWQ
• UDI-Device Identifier: 05415067045010
• UDI-Public: (01)05415067045010(17)270908(10)C00003983
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/20/2024

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 Catalogue Number: 25MJ-501
• Device Lot Number: C00003983
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/01/2023; 04/25/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/20/2023; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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