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

Model Number	29MECJ-502
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022 a 29mm sjm masters series valve expanded cuff was implanted successfully.On an unknown date, the patient developed a severe paravalvular leak.It was noted that during the same time the patient had jaundice, unrelated to the paravalvular leak, that resolved after treatment.The valve was explanted (b)(6) 2022 and replaced with a new 29mm sjm masters series valve expanded cuff.It was noted that the patient experienced pulmonary hypertension during surgery.The patient is reported to be stable.No additional information was reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to perivalvular leak was reported.The investigation found that both leaflets were intact and opened and closed completely without difficulty.No material was seen within the pivot recesses or on the surfaces of the mechanical leaflets.The sewing cuff was intact.There was a patchy fibrous pannus formation on the sewing cuff which did not appear to impinge upon the mechanical components.No inflammation.Sections of material removed from the sewing cuff consisted of fibrous tissue consistent with pannus.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 reported incident could not conclusively be determined.H1: report type corrected to serious injury.

• 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: 15750063
• Report Number: 2135147-2022-01970
• Device Sequence Number: 14192700
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• 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: 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): 02/03/2023

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: 02/22/2026
• Device Model Number: 29MECJ-502
• Device Catalogue Number: 29MECJ-502
• Device Lot Number: 7856556
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Male