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 Problems Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Thrombus (2101); Stenosis (2263)

Event Date 03/30/2019

Event Type  Injury  

Event Description

On (b)(6) 2014, a 21mm regent valve was implanted.In (b)(6) 2019, the patient presented to the hospital with dyspnea.A tee was performed revealing stenosis of the valve.The patient was discharged but was admitted again two months later with the same complaint.The physician reported that the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy.On (b)(6) 2019, the valve was explanted and replaced with a 21mm magna ease tissue valve so that the patient wouldn't require anticoagulation therapy.

Manufacturer Narrative

The reported event of stenosis was confirmed.There was pannus ingrowth on the inflow surface, which narrowed the inflow diameter.Thrombus was found in the pivot areas, and was gram stained for bacteria, which was negative.The leaflets had limited mobility due to the pannus and the thrombi in the pivot recesses.Microcalcifications were present within the pivot thrombi and pannus.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the pannus and thrombus could not be conclusively determined, however, information form the field indicated "the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy".

Event Description

On (b)(6) 2014, a 21mm regent valve was implanted.In (b)(6) 2019, the patient presented to the hospital with dyspnea.A tee was performed revealing stenosis of the valve.The patient was discharged but was admitted again two months later with the same complaint.The echocardiogram revealed 3rd degree aortic insufficiency and high gradients.The physician reported that the patient had psychiatric issues and that the patient didn't adhere properly to the anticoagulation therapy.On (b)(6) 2019, the valve was explanted and replaced with a 21mm magna ease tissue valve so that the patient wouldn't require anticoagulation therapy.

• 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: 8700131
• MDR Text Key: 148028450
• Report Number: 2648612-2019-00042
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2018
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 4380721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention