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

Model Number E100-31M

Device Problem Obstruction of Flow (2423)

Patient Problems Pneumonia (2011); Heart Failure (2206)

Event Date 11/28/2019

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) 2012, a 31mm epic stented porcine valve was implanted in the mitral positon.A 23mm carpentier-edwards perimount magna valve was implanted in the aortic position.On an unknown date post implant procedure the patient presented at the hospital with symptoms of cardiac failure.Valve dysfunction was confirmed in both the aortic and mitral tissue valves.The patient was closely monitored.On (b)(6) 2019, the patient was hospitalized due to pneumonia and heart failure.The patient recovered and was discharged.On (b)(6) 2019, the patient was hospitalized for heart failure symptoms.On (b)(6) 2019, the 31mm epic valve was explanted and replaced with a 27mm magna mitral valve by edwards.The aortic valve was also explanted and replaced with another 23mm magna ease edwards valve.The patient was reported to be stable condition.

Manufacturer Narrative

Additional information: d10, h3, h6.Explant was reported due to heart failure and valve dysfunction.The investigation found that all three cusps contained calcifications.There was circumferential fibrous pannus ingrowth on the inflow and outflow surfaces, which narrowed the inflow diameter.There was a hole in cusp 3 which was associated with calcifications.No inflammation was present.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 hole could not be conclusively determined; however it was associated with a calcification.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 9659605
• MDR Text Key: 177628482
• Report Number: 3001883144-2020-00007
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2016
• Device Model Number: E100-31M
• Device Catalogue Number: E100-31M
• Device Lot Number: 3727071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72