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

Model Number E100-25M

Device Problem Obstruction of Flow (2423)

Patient Problems Mitral Valve Stenosis (1965); Heart Failure (2206)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

In 2000 an unknown mechanical heart valve was implanted.On (b)(6) 2017, the unknown mechanical heat valve was explanted and a 25mm epic valve was implanted in the mitral position due to thrombosis.An emergency surgery was performed due to heart failure caused by serve mitral stenosis and the epic valve was explanted.A 23mm masters series mechanical valve was implanted.Upon explant, pannus-like growth was noted on the valve.The patient was reported to be in stable condition.

Manufacturer Narrative

Explant was reported due to heart failure and stenosis.The investigation found that there was thrombus on the outflow of all three cusps, immobilizing them.No inflammation, significant calcifications, or pannus were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The immobilizing thrombus on the outflow of the cusps would have contributed to the reported stenosis.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 9911038
• MDR Text Key: 185973854
• Report Number: 3008452825-2020-00179
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2020
• Device Model Number: E100-25M
• Device Catalogue Number: E100-25M
• Device Lot Number: 5595689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention