MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 19AGN-751

Device Problems Incomplete Coaptation (2507); Biocompatibility (2886)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "experience of using tissue plasminogen activator for pediatric thrombotic valve", was reviewed.The article reported a case study on a 2-year-and-eight-month-old boy with left isomerism, atrioventricular septal defect, and inferior vena cava defect for which hepatic inclusion was performed.Extracorporeal membrane oxygenation(ecmo) was used on the patient due to circulatory failure after common atrioventricular valve formation.Due to severe atrioventricular valve regurgitation the patient underwent artificial valve replacement (sjm regent 19 mm), left modified blalock-taussig shunt(mbts) and intrapulmonary-artery septation( ipas) were conducted 37 days after the initial operation, and ecmo was withdrawn.On the 56th day after the valve implant, a decrease in the opening angle of both leaflets on the regent valve was observed.Judging that the risk of reoperation was high, t-pa 0.6 mg / kg / dose was administered twice, and then the open angle of the leaflets was improved.Head magnetic resonance imaging(mri) performed as a detailed examination after ecmo revealed subdural hematoma and multiple microcerebral hemorrhage, but the relationship with t-pa was unknown, and there was no change in neurological symptoms before and after administration of t-pa.

Manufacturer Narrative

Additional information for:g3, g6, h2, h6, and h10 as reported in a research article, a patient had thrombus on the valve 51 days after valve implant.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.

• Brand Name: SJM REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 11699935
• MDR Text Key: 246464983
• Report Number: 2648612-2021-00045
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 2 YR