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

Model Number 21AGFN-756

Device Problem Leak/Splash (1354)

Patient Problems Aortic Insufficiency (1715); Chest Pain (1776); Dyspnea (1816)

Event Date 11/26/2018

Event Type  Injury  

Event Description

Information received from patient device tracking notes that on (b)(6) 2018, a 21mm regent valve was implanted in the aortic position.On (b)(6) 2018, the patient presented with aortic insufficiency, shortness of breath, and chest pain.The patient was reported to have not been compliant with their anticoagulation medication.After consultation, the regent valve was explanted and replaced with at 21mm trifecta valve.The patient is reported to be discharged.

Manufacturer Narrative

An event of aortic insufficiency, shortness of breath, and chest pain was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Information from the field indicated that the patient was reported not to have been compliant with their anticoagulation medication.

Event Description

Information received from the patient to patient device tracking notes that on (b)(6) 2018, a 21mm regent valve was implanted in the aortic position and that it failed and the patient required reoperation.Additional information obtained from the implanting physician reported that the patient presented on (b)(6) 2018 with aortic insufficiency, shortness of breath and chest pain.The patient had been non-complaint with anticoagulation and that resulted in symptoms.After consultation, the decision was made to explant the mechanical valve (regent valve) and implant a tissue valve.A 21mm trifecta valve was implanted and per report the patient is discharged.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• 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: 8208788
• MDR Text Key: 131800921
• Report Number: 2648612-2018-00108
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 6524655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR