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

Model Number E100-27M

Device Problems Backflow (1064); Biocompatibility (2886); Physical Resistance/Sticking (4012)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 08/31/2017

Event Type  Injury  

Event Description

It was reported a patient underwent a mitral valve replacement procedure on (b)(6) 2017.A 27 mm epic stented porcine heart valve w/flexfit system was chosen for procedure.On (b)(6) 2017 the patient was admitted to the hospital after complaining of chest pain for ten days.Further tests revealed the patients cardiac dysfunction was a "level iv." imaging of the left ventricle confirmed mitral valve dysfunction.On (b)(6) 2017 the patient underwent an explant procedure of their epic mitral valve.Upon explant, the cusps were found to be "stuck" and blood clots were observed in the leaflets.The patient had a new, 27mm epic mitral valve placed.The patient remained stable throughout the procedure and the patients condition continued to improve.The patient was discharged on (b)(6) 2017.The patient remains in stable condition to date.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of "the cusps were found to be "stuck" and blood clots were observed in the leaflets" was reported.A more comprehensive assessment could not be performed as the device 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, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13237680
• MDR Text Key: 283689777
• Report Number: 3007113487-2021-00132
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/12/2022
• 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; Hospitalization