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

Model Number 19AGN-751

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Endocarditis (1834); Pseudoaneurysm (2605); Heart Block (4444)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An article "aortic para-annular abscess following infective endocarditis requiring three times of operation, report of a case", was reviewed.The research article presents a case study of a (b)(6)-year-old man with comorbidity of diabetes mellitus(dm).The patient had symptoms of epigastric pressure, abdominal pain, and loss of appetite persisted for a month.The patient also had impaired consciousness and dm ketosis by the time when diagnosed with active aortic valve endocarditis accompanied by massive regurgitation, complete atrioventricular block, para-annular abscess and a mobile large vegetation.With temporary pacing inserted, the patient underwent emergency resection of the aortic valve, direct closure of the abscess with an autologous pericardium patch and aortic valve replacement (avr) using a 19mm sjm regent heart valve.The abscess was continuous from non-coronary cusp (ncc) to aml (anterior mitral leaflet), and presented with left ventricular-right atrial communication that opened in the right atrium.The acquired communication between the left ventricle and the right atrium was closed simultaneously.On the ncc side, the suture thread was penetrated from outside the aortic wall and a 19mm regent valve was fixed to the supra-annular position(first operation).Patient received antibiotics, that continued for two weeks.An adjacent mitral para-annular abscess and another vegetation was seen by echocardiography.There were no problems on the regent valve noted at that time.The patient was treated surgically 20 days post-operatively from the first surgery.The patient underwent mitral valve replacement with a 25mm sjm mechanical valve and closure of the annular abscess(second operation.) antibiotic administration continued for two more weeks.It was reported that 21 days after the second operation, c-reactive protein (crp) lowered, but transesophageal echocardiography (tee) showed a left ventricular outflow tract pseudoaneurysm with a blood flow of 4cm over 2/3 circumference of the annulus to ncc-left coronary cusp(lcc) at the aortic valve position.Since the patient was diagnosed with aortic valve infection and the atrioventricular block (av block) recurred, a third operation was performed 21 days after the mitral valve replacement procedure.Closure of the false aneurysm and the re-do avr with a 17mm sjm regent heart valve were performed.Upon removal of the 19mm sjm regent valve, the autologous pericardium had melted and detached, and the abscess cavity had expanded to form a pseudoaneurysm, but there was no spread of infection observed on the mitral valve.The pseudoaneurysm opening was closed with a pericardial patch and a 17mm regent valve was implanted.Administration of antibiotics continued and crp negative conversion was confirmed.On the 35th day after the operation, the drug was changed to oral medication, and the patient was discharged after confirming that the inflammatory reaction did not recur.It was noted that three years had passed and there was no recurrence.Oral antibiotics were continued.No further information is available.

Manufacturer Narrative

Additional information for: g3, g6, h2, h6, and h10 an event of endocarditis on the prosthetic following implant in a patient with active endocarditis was reported.A more comprehensive assessment could not be performed as the device was not returned 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: 11773364
• MDR Text Key: 263470645
• Report Number: 2648612-2021-00047
• 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: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR