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

Model Number E100-29M

Device Problems Backflow (1064); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problems Mitral Insufficiency (1963); Hemolytic Anemia (2279)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

An event of insufficiency due to a torn cusp was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2017, a 29mm epic valve was selected for implant.On (b)(6) 2020, the valve was explanted after echocardiogram revealed the patient had severe mitral insufficiency after she became admitted due to hemolytic anemia.Upon explant, one of the leaflets had a tear.A replacement valve was implanted and the patient was reported to be stable.

• 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. (PAMPULHA); 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. (PAMPULHA); 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: 9803853
• MDR Text Key: 187624435
• Report Number: 3001883144-2020-00017
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P040021
• 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
• Report Date: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2019
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: BR00004581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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; Life Threatening; Other; Required Intervention