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

Model Number 17AGN-751

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

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

An article "experience of using tissue plasminogen activator for pediatric thrombotic valve", was reviewed.The research article presents a case study of a (b)(6)-old girl who underwent mitral valve replacement with a 17mm sjm regent valve for idiopathic mitral valve chordae tendineae rupture.It had been confirmed by echocardiography that the two leaflets were functioning and were movable immediately after the implant.Immobilization of one leaflet was observed on the 21st day after the implant.The patient was diagnosed with a thrombotic valve.Since the patient's hemodynamics were stable, thrombolytic therapy was selected.Recovery of mobility of the two leaflets were confirmed after three doses of tissue plasminogen activator (t-pa) 0.6 mg / kg / dose.No complications occurred and no recurrence of thrombotic valves had been observed so far.No additional information available.

Manufacturer Narrative

As reported in a research article, thrombus was found on the leaflet 21 days after 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: 11732367
• MDR Text Key: 247521009
• Report Number: 2648612-2021-00041
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AGN-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): Required Intervention
• Patient Age: 7 MO