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

Model Number E100-27M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Ventricular Fibrillation (2130); Pericardial Effusion (3271)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported the patient underwent implant of a 27 mm epic stented porcine heart valve w/flexfit system on (b)(6) 2019.On day one post implant, the patient developed ventricular fibrillation and resuscitation efforts were required.External chest compressions were performed, the patient was defibrillated with 150 joules x 1 and medications were given which resulted in a successful conversion to a sinus rhythm.During the same hospitalization, on (b)(6) 2019, the patient presented with chest discomfort and shortness of breath.A bedside echocardiograph (echo) was performed revealing a moderate pericardial effusion.The effusion was drained and the patients condition improved.On (b)(6) 2019, the patient presented with shortness of breath once again.This time, a bedside echo was performed revealing pleural effusions on both sides.The patient underwent chest tube placement for treatment and the patients condition improved.On (b)(6) 2019, it was determined the patients chest wounds had not healed well.The patient underwent debridement of the wound and was treated with medicine and additional chest tube placement.On (b)(6) 2019 the patient had recovered and was discharged.No additional information has been provided.

Manufacturer Narrative

An event of ventricular fibrillation, pericardial effusion, shortness of breath, and pleural effusion was reported.A more comprehensive assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13698010
• MDR Text Key: 286997633
• Report Number: 3005334138-2022-00116
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model 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: 03/21/2022
• 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): Required Intervention