MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Patient-Device Incompatibility (2682)

Patient Problems Low Cardiac Output (2501); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, after the valve implantation further surgical intervention was needed in some patients.This was intervention was either implanting an intra-aortic balloon pump, re-exploration for bleeding, pericardial effusion, and paravalular leakage.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.

Event Description

Reference manufacturing number: 3007113487-2019-00042, 3007113487-2019-00044, 3007113487-2019-00045, 3007113487-2019-00046, 3007113487-2019-00047.It was reported through a research article identifying trifects that may be related to surgical intervention.The patient demographics are 73.5 +/-6.4 years old, with 54.1% male and 45.9% female.Details are listed in the article, titled [durability and clinical experience using a bovine pericardial prosthetic aortic valve].It was reported in the article that 1,241 patients were implanted with a trifecta bioprosthetic aortic valve.The patients had a history of aortic valve stenosis, aortic valve insufficiency, peripheral vascular disease, coronary artery disease, pulmonary disease, stroke, hypertension, diabetes, hyperlipidemia and kidney disease.Surgical intervention was performed for the following: 40 patients had a surgical intervention of intra-aortic balloon pump due to low co syndrome, 92 patients had re-exploration for bleeding, two patient had pericardial effusion, and one patient had paravalvular leakage.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9527323
• MDR Text Key: 174411765
• Report Number: 3007113487-2019-00043
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2019

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/27/2019
• 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; Other; Required Intervention