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

Catalog Number 15MHPJ-505

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Thrombosis/Thrombus (4440)

Event Date 05/05/2023

Event Type  Injury  

Event Description

The article, "mitral valve replacement in infants and children: experience using a 15 mm mechanical valve", was reviewed.The article presents a retrospective single center study experience aimed to describe the center¿s experience with 15 patients who underwent mmvr with 15mm sjm masters hp valve over the past 13 years.The article concluded that compared to other similar studies, this study was distinguished by a lower rate of major adverse events than previously reported, durability of the device, and a rapid post operative recovery time.Appropriate and consistent anticoagulation is a significant challenge in this age group.[(b)(6)].The time frame of this study was from 2009 to 2022.A total of 15 patients were included in this study.At the time of procedure, the average age was 6.2 months, and the average weight was 5.16kg.The average gender was male.Comorbidities included atrioventricular canal defect, prior mitral valve repair, stenosis, regurgitation.

Manufacturer Narrative

Literature article: mitral valve replacement in infants and children: experience using a 15 mm mechanical valve summarized patient outcomes/complications of implant of a 15mm mechanical heart valve for mitral valve replacement were reported in a research article.Some of the complications reported were diaphragm plication, catheter-based assessment, cardiac arrest, mitral valve replacement due to thrombosis, hospitalization and surgical intervention; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES EXPANDED HEMODYNAMIC PLUS VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17390465
• MDR Text Key: 319828659
• Report Number: 2135147-2023-03168
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15MHPJ-505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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