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

Model Number E100-27M

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

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) 2018, a 27mm epic valve was implanted in the mitral position.On an unknown date leaflet dysfunction was noted.On (b)(6) 2020, the valve was explanted and pannus was reported.The valve was replaced with an mosaic tissue valve by medtronic.The patient was reported to be in stable condition.

Manufacturer Narrative

Additional information: d10, h3, h6.The reported "leaflet malfunction" was confirmed.Thrombus was present on cusps 1 and 2, immobilizing the cusps.There were folds which caused incomplete coaptation in all three cusps.There was thin fibrous pannus on the inflow surface of cusp 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 and the product met all specifications.The thrombus noted could have contributed to the reported leaflet malfunction.

• 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: 9967160
• MDR Text Key: 187867718
• Report Number: 3001883144-2020-00038
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: E100-27M
• Device Lot Number: BR00011513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention