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

Model Number E100-23A

Device Problem Calcified (1077)

Patient Problems Aortic Insufficiency (1715); Chest Pain (1776); Dizziness (2194); Diaphoresis (2452)

Event Date 12/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a 23mm epic stented porcine heart valve w/flexfit system was implanted.11 months later the device was explanted and observed to have severe calcification.The device was successfully replaced with a 21mm epic supra valve w/flexfit.A pathology test was ordered for the explanted device.The patient is reported to be stable.

Event Description

On (b)(6) 2018, a 23 mm epic stented porcine heart valve w/flexfit system was implanted.On (b)(6) 2019, the patient presented with dizziness, chest pain, and diaphoresis.On (b)(6) 2019, the device was explanted and observed to have severe calcification.The device was successfully replaced with a 21 mm epic supra valve w/flexfit.A pathology test was ordered for the explanted device.The patient is reported to be stable and has been discharged.The patient was not diabetic and didn't have history of renal insufficiency.

Manufacturer Narrative

An event of dizziness, chest pain and diaphoresis was reported.The reported calcification could not be confirmed.Fibrous pannus ingrowth was present on the inflow surface of all three cusps.Outflow thrombus was noted on cusps 1 and 2.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the pannus and thrombus could not be conclusively determined.

• 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: 8222787
• MDR Text Key: 132246776
• Report Number: 3001883144-2019-00001
• 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,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: E100-23A
• Device Lot Number: BR00014419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80