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 E100-27M

Device Problems Backflow (1064); Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/17/2021

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 that a 27mm epic stented porcine heart valve w/flexfit system was implanted in the patient's mitral position on (b)(6) 2019.An abbott sizer (model#: b1000) was used in the surgery.Severe mitral stenosis (ms) and mild to moderate mitral regurgitation (mr) occurred, leading to the epic valve explant on (b)(6) 2021.The epic valve was explanted and replaced with a 23mm mitris resilia mitral valve (manufacturer: edwards lifesciences).It was reported that there were no clear findings in the echocardiograph until (b)(6) 2020, and the ms progressed rapidly.Upon explant, pannus covered the entire valve which made the valve invisible even from the left atrium.One of the leaflets was ruined by pannus.The surgeon thought that the issue was due to the ms and mr caused by pannus.There was a thrombus noted in the left atrial appendage, but the findings of the thrombus on the valve were not clear.The use of direct oral anticoagulant(doac) for the left atrial appendage thrombus did not change the patient's state significantly.Analysis was requested on the valve in order to confirm whether there was thrombus on the valve.

Manufacturer Narrative

Explant was reported due to "severe mitral stenosis (ms) and mild to moderate mitral regurgitation (mr) occurred".The investigation found that there was circumferential fibrous pannus ingrowth on both the inflow and outflow surfaces, with fusion of commissures and limited cusp mobility.Cusp 2 had a horizontal fold with incomplete coaptation.Cusp 3 was torn, with thinning and loss of collagen fibers.There was no acute inflammation or significant calcifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The tears and folds causing incomplete coaptation could have contributed to the reported regurgitation.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site, which could have contributed to the formation of the tear; the fibrous pannus ingrowth noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12271182
• MDR Text Key: 264936707
• Report Number: 3014918977-2021-00043
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: E100-27M
• Device Lot Number: 6214443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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
• Patient Age: 79 YR
• Patient Sex: Female