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

Model Number E100-31M-00

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The reported event of an obstruction causing an elevated gradient could not be confirmed.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2020, a 31mm epic stented porcine heart valve w/flexfit system was selected for implant.After placing the valve the surgeon noted lvot (left ventricular outflow tract) obstruction that was causing elevated gradient.The patient was placed back on the pump and the valve was explanted and replaced with a 29mm epic stented porcine heart valve w/flexfit system.The procedure was completed successfully and the patient was reported to be in stable condition.

• 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: 10727524
• MDR Text Key: 212757178
• Report Number: 3001883144-2020-00099
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: E100-31M-00
• Device Catalogue Number: E100-31M-00
• Device Lot Number: BR00019376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• 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): Required Intervention