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

Model Number 25MECJ-502

Device Problem Incomplete Coaptation (2507)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/17/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2022, a 25mm sjm masters series valve expanded cuff was successfully implanted.Prior to the implant procedure, it was reported that the patient was in mild-moderate heart failure condition according to the new york heart association (nyha) functional classification.On (b)(6) 2022, the patient was admitted to the hospital with symptoms of sudden onset breathlessness, which was progressive in nature, vomiting, hypotension, multiple organ dysfunction syndrome (mods), and cardiac arrest.It was determined that the masters valve was stuck in the open position due to a significant increase in the transvalvular gradients across the prosthetic mitral valve.The patient was placed on high inotropic supports and mechanical ventilatory support.While thrombotic treatment was being attempted by administration of streptokinase, the patient expired.The patient's cause of death was multiple organ dysfunction syndrome.No additional information was provided.

Manufacturer Narrative

An event of sudden onset breathlessness, vomiting, hypotension, multiple organ dysfunction syndrome (mods), cardiac arrest and patient death was reported.A returned device assessment could not be performed as the device remains implanted and 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 16130825
• MDR Text Key: 306999974
• Report Number: 2135147-2023-00136
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• 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: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: C00002035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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): Death; Hospitalization; Required Intervention