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

Model Number 29MECJ-502

Device Problem Perivalvular Leak (1457)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/13/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

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

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
• 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: 15750063
• MDR Text Key: 307015437
• Report Number: 2135147-2022-01970
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006545
• UDI-Public: 05414734006545
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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): Hospitalization; Required Intervention
• Patient Sex: Male