MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SJM TISSUE HEART VALVE (UNKNOWN); HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Leak/Splash (1354); Microbial Contamination of Device (2303)

Patient Problems Endocarditis (1834); Pulmonary Regurgitation (2023)

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis and regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Per the instructions for use, abbott tissue valves are indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve.Udi number unknown as the serial number is unknown.

Event Description

From a publication: prosthetic pulmonary valve and pulmonary conduit endocarditis: clinical, microbiological and echocardiographic features in adults reported on a single center experience of adults with prosthetic pulmonary valve (ppv) or right ventricle to pulmonary artery conduits (rvpac) infective endocarditis and the yield of transthoracic and transesophageal echocardiogram as diagnostic tools.A retrospective analysis of 17 adults (mean age 34 years & 29% female) occurred.Four patients had prior episode of endocarditis occurring a median interval of 5.3 years after ppv/rvpac due to staph aureus, coagulase-negative staph and strep.Eleven patients required replacement surgery as a consequence of the ie.Prosthetic valve endocarditis is an uncommon complication of valve surgery with an incidence of 0.3 to 1.2% per year; however it carries significant morbidity and mortality.For patients with complex congenital surgery and comorbidities, the clinical diagnosis can be challenging and tee is currently the widely used diagnostic tool.Tee is technically difficult due to the anterior position of the replacement prosthesis and variable fibrosis/calcification.Two of the 17 patients had abbott (st.Jude) bioprothesis.For a 27mm bioprothesis, findings were a globular mobile mass attached to the prosthesis, which was poorly seen on tte and not seen on tee.There was mild regurgitation.The publication does not provide details on operative or pathological findings.For the 29mm bioprothesis, findings were large mobile mass attached to the cusp (1.4 x 0.8 cm).The findings were seen on tte and the patient had moderate regurgitation.This valve was removed and intraoperative findings were prosthesis obstructed with vegetation and pathological findings were multiple vegetations, active infection.The conclusion of the publication was that neither tte or tee alone is sensitive enough to support a ppv/rvpac endocarditis diagnosis and they should complement each other in evaluation of patients with suspected endocarditis.The article contained limited information to correlate the 2 patients with existing complaints and no additional information is anticipated.

• Brand Name: SJM TISSUE HEART VALVE (UNKNOWN)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7172388
• MDR Text Key: 96640053
• Report Number: 3008452825-2018-00009
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• 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?: Yes
• Date Manufacturer Received: 12/19/2017
• 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