MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-27M

Device Problems Obstruction of Flow (2423); Gas/Air Leak (2946)

Patient Problems Endocarditis (1834); High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a epic valve was replaced due to thrombosis and endocarditidis.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

It was reported through a research article identifying 27mm epic stented porcine heart valve that was related to sever regurgitation from pulmonary hypertension and severe mitral regurgitation in a (b)(6) year old male with history of intravenous drug use.The valve was explanted due to thrombus and endocarditis.Details are listed in the attached article, titled "a case of bioprosthetic mitral valve dysfunction, initially presenting with valve thrombosis following by recurrent thrombosis and endocarditis.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9321402
• MDR Text Key: 166370496
• Report Number: 3001883144-2019-00112
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• 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; Required Intervention
• Patient Age: 57 YR