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

Model Number 17AGN-751

Device Problems Fracture (1260); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Chest Pain (1776); Dyspnea (1816); 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

It was reported a 17 mm sjm regent heart valve was explanted (b)(6) 2021 due thrombus formation.During explant, one leaflet broke down while explanting and all broken pieces were retrieved from the patient.The thrombus had lead to an obstruction to the leaflets movement.The patient had been prescribed an anticoagulant to maintain the recommended international ratio (inr) for clot prevention.The patients inr was checked quarterly and the patient was non-compliant with their therapy.The patient complains of symptoms of dyspnea, angina and palpitations.The patient does not have any history of clotting disorders.The patient is reported stable.No further information has been provided.

Manufacturer Narrative

An event of thrombus, leaflet fracture upon valve explant, obstruction of leaflet movement, dyspnea, angina, and palpitations was reported.A more comprehensive assessment could not be performed as the device 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 all specifications.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: 12116438
• MDR Text Key: 263508213
• Report Number: 2648612-2021-00067
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Model Number: 17AGN-751
• Device Lot Number: 6708042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention