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

Model Number 27AJ-501

Device Problem Leak/Splash (1354)

Patient Problems Death (1802); Endocarditis (1834); Mitral Regurgitation (1964)

Event Type  Death  

Event Description

The following comes from a case report titled, "right and left side infective endocarditis after mitral valve replacement".In 2017, a mvr was performed with a 27mm masters heart valve was implanted due to mitral regurgitation due to posterior papillary muscle tear.Post-operatively, the patient was reported to be stable.On day 67 post-implant, the patient presented with a fever of 38.1°c and (b)(6) was detected by blood culture.Tee revealed a 3mm wart, proximal to the prosthetic valve, and the patient was diagnosed with endocarditis.The patient was prescribed an injection of rifampicin (350 mg/day), and after two weeks, tee revealed the wart had disappeared.The patient continued to have a fever, and infiltrative shadow was found in the right lung.Since implant, the patient had symptoms of deterioration of swallowing and complicated pneumonia aspiration.The patient's respiratory condition worsened suddenly and tracheal intubation was performed.Tee revealed the sway of the prosthetic valve and perivalvular leakage, and an annulus abscess was suspected.Shortly after, the patient expired due to cardiogenic shock from perivalvular leakage, sepsis and septic pulmonary embolism.(case report study id: (b)(4)).

Manufacturer Narrative

An event of endocarditis, perivalvular leakage, and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Information from the field indicated that "the patient expired due to cardiogenic shock from perivalvular leakage, sepsis and septic pulmonary embolism.¿.

• Brand Name: SJM MASTERS SERIES MECHANICAL 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8039994
• MDR Text Key: 126211482
• Report Number: 2648612-2018-00092
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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 Model Number: 27AJ-501
• Device Catalogue Number: 27AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 68 YR