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

Device Problem Leak/Splash (1354)

Patient Problem Mitral Insufficiency (1963)

Event Type  Injury  

Event Description

The following information comes from the abstract of the "the 29th annual scientific meeting of the japanese society of echocardiography", 2018, vol.29, p14-19.Title: a case of repeated emergency surgical intervention for prolapsed mitral tissue valve into left atrium.In 2000, a 28 mm non-abbott cosgrove ring was implanted in the patient's mitral position due to mitral regurgitation caused by ruptured chordae tendineae.In 2002, the valve was replaced due to infective endocarditis and this 29 mm abbott mechanical heart valve (model and serial unknown) was implanted in the mitral position.In 2011, a transthoracic echocardiography (tte) revealed perivalvular leakage and flail of the valve seat.The patient was diagnosed with prosthetic valve endocarditis and the valve was explanted.Upon explant of the valve, symptoms of infection around this valve were observed.The procedure was completed with a 29 mm non-abbott valve.There is no information available regarding the model and serial number of this valve, the exact dates of the respective event in this case including the implant/explant date of this valve.The patient specific information of patient identifier, birthdate and weight are not available for this case.

• Brand Name: SJM MECHANICAL HEART VALVE (UNKNOWN)
• 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: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7682491
• MDR Text Key: 113803003
• Report Number: 0002648612-2018-00055
• 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: Other
• Type of Report: Initial
• Report Date: 07/12/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 07/12/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR