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

Model Number CVD0030

Device Problems Calcified (1077); Material Integrity Problem (2978)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758)

Event Date 01/27/2020

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) 2013, a 27mm epic stented porcine heart valve w/flexfit system was implanted in the patient¿s mitral position.On (b)(6) 2020, the valve was explanted due to pannus ingrowth and valve cusp sclerosis.The physician reported that the patient had congenital barlow's type mitral valve disease.Upon explant, calcification was observed on the entire valve.A replacement 27/29mm on-x mechanical heart valve was successfully implanted and the patient was reported to be stable.

Manufacturer Narrative

The reported pannus and valve cusp sclerosis in a patient with a history of barlow's type mitral valve disease was confirmed.The reported calcification was not found.Circumferential fibrous pannus ingrowth was present on the outflow surface, narrowing the outflow diameter and spanning the cusp commissures at all three stent posts and creating folds in the free-edges of cusps 2 and 3.Outflow thrombus covered all three cusps, immobilizing them.Fibrous pannus ingrowth had encroached onto the inflow base of cusps 2 and 3.A tear was present on the free-edge of cusp 1.No 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 at the time of commercialization.The extent of the pannus ingrowth at stent posts 1 and 3 were possible evidence of interaction with the aortic wall, and the pannus and thrombus were consistent with the reported sclerosis.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9760872
• MDR Text Key: 187623770
• Report Number: 3001883144-2020-00012
• 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: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2016
• Device Model Number: CVD0030
• Device Catalogue Number: CVD0030
• Device Lot Number: 3990562
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention