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 E100-23A

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Valvular Stenosis (2697)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

In (b)(6) 2018, a 23mm epic valve was implanted.During follow up, structural valve deterioration was observed.The valve was explanted and exchanged with a medtronic ap 360.Stenosis and calcification were observed on the explanted valve.The patient is stable post procedure.

Manufacturer Narrative

The valve was explanted following observation of structural valve deterioration.The calcification noted at explant could not be confirmed, as no calcifications were found to be present upon histopathological examination.Mild inflow surface fibrous thickening was present along the commissure on all three cusps.Outflow pannus was noted, which did not adhere to the cuspal tissue, but did add small impediment to cuspal mobility directly adjacent to the stent post.No acute 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 at the time of commercialization.The mild inflow fibrous thickening and detached pannus on the outflow surface were potential contributing factors to the reported stenosis.

• 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 01897 -405; CS 01897-4050
• MDR Report Key: 9979850
• MDR Text Key: 188563692
• Report Number: 3008452825-2020-00207
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: E100-23A
• Device Lot Number: 5949135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention