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

Catalog Number 15MHPJ-505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2023

Event Type  Injury  

Manufacturer Narrative

Literature article: mitral valve replacement in infants and children: experience using a 15 mm mechanical valve.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "mitral valve replacement in infants and children: experience using a 15 mm mechanical valve", was reviewed.The article reported a case study of patient weighing 8.2kg with complete atrio-ventricular canal defect.It was reported on an unknown date, a 15mm sjm masters hp valve was implanted in the patient.It was later reported on an unknown date when the patient was 8.4years old, a decision was made to perform a mitral valve replacement procedure.The 15mm masters valve was replaced with a 25mm unknown valve.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.[the primary and corresponding author is marcos mills, emory university school of medicine/children¿s healthcare of atlanta division of pediatric cardiology 2835 brandywine road, suite 400, atlanta, ga 30341, with corresponding email: mfmill6@emory.Edu].

Manufacturer Narrative

As reported through a literature review a patient with complete atrio-ventricular canal defect and had mechanical heart valve (mhv - hp) implanted.A patient underwent a mitral valve replacement procedure.The 15mm masters valve was replaced with a 25mm unknown valve.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.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 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: 17390781
• MDR Text Key: 319865744
• Report Number: 2135147-2023-03174
• 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,Followup
• Report Date: 09/08/2023

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?: No
• 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: 08/17/2023
• 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