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 E100-27M

Device Problems Material Perforation (2205); Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Prolapse (2471)

Event Date 12/23/2019

Event Type  Injury  

Event Description

On (b)(6) 2016, a 27mm epic stented porcine heart valve w/flexfit system was implanted in the patient's mitral position.A cardiac murmur was confirmed three years after the surgery, and mitral regurgitation was observed in the detailed examination with echocardiography.A re-do mitral valve replacement was performed on (b)(6) 2019.The epic valve was explanted and replaced with a 27mm magna mitral ease (manufacturer: edwards lifesciences, serial# unknown).There were no calcification observed on the valve.One of the leaflets remained folded (prolapsed), and the other leaflets look thinned and may be perforated.The patient is in stable condition.

Manufacturer Narrative

Explant was reported due to regurgitation.The investigation found that a tear was present in cusp 3.Cusp 3 also contained a fold/retraction.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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 demonstrated mild loss of collagen and thinning at the tear site, which could have contributed to the tear.

• 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 1897- 4050; CS 1897-4050
• MDR Report Key: 9615677
• MDR Text Key: 175902424
• Report Number: 3008452825-2020-00040
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2020
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 5379573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/25/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR