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

Model Number E100-31M

Device Problems Backflow (1064); Biocompatibility (2886)

Patient Problems Endocarditis (1834); Mitral Regurgitation (1964)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2017, an mvr was performed and a 31mm epic stented porcine heart valve w/flexfit system was implanted in the patient's mitral position.On an unspecified date, mitral regurgitation occurred due to infectious endocarditis and a re-do mvr was performed on may 14, 2020.The epic valve was explanted and replaced with another 31mm epic stented porcine heart valve w/flexfit system.No patient consequences were reported.

Manufacturer Narrative

Explant was reported due to mitral regurgitation.The investigation found that cusp 2 was torn and there degenerative changes to the cusp tissue at the site of the tear.There were calcifications present in cusps 2 and 3.A think layer of fibrin was present on all three cusps.Acute and chronic inflammation was found on cusp 3 and a gram stain was negative for organisms.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear could not be conclusively determined; however, the degenerative changes noted to the tissue could have contributed to the tear formation.

• 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 (CVD); 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: 10075891
• MDR Text Key: 191605508
• Report Number: 3008452825-2020-00248
• 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: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: E100-31M
• Device Lot Number: 5535367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR