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 E100-29M

Device Problem Biocompatibility (2886)

Patient Problems Dyspnea (1816); Complete Heart Block (2627)

Event Date 03/31/2020

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

On (b)(6) 2014, a 29mm epic valve was implanted.On (b)(6) 2020, the patient presented with dyspnea on exertion and the valve was explanted.Upon explant, thrombus formation was reported on the ventricular side.A competitor's 31/33mm on-x mechanical mitral valve was successfully implanted.On an unknown date, a permanent pacemaker was implanted.No patient consequences were reported.Additional information was requested, however is not available.

Manufacturer Narrative

The reported thrombus was confirmed.Outflow thrombus covered all three cusps.Fibrous pannus ingrowth encroached onto the inflow base of cusps 1 and 3, and straddled the outflow commissure at all three stent posts, most markedly at stent post 3.Cusp 3 was torn at stent post 3, and the aforementioned tissue created a fold and retraction.No acute inflammation or significant calcifications were found.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 thrombus and pannus formation had obstructed cuspal mobility, and was consistent with the reported patient effect of dyspnea upon exertion.

• 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: 9992557
• MDR Text Key: 190054669
• Report Number: 3001883144-2020-00032
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2015
• Device Model Number: E100-29M
• Device Lot Number: 4294080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 71