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

Model Number E100-29M

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/12/2018

Event Type  Injury  

Event Description

On (b)(6) 2015, a re-do mitral valve replacement (mvr) was performed and a 29mm epic valve was implanted.On an unknown date, the patient presented with severe mitral regurgitation.On (b)(6) 2018, a second re-do mvr was performed and the epic valve was explanted and replaced with a 27mm sorin bicarbon mechanical valve.Upon explant, approximately half of the epic valve anterior leaflet was torn and prolapsed.There were no findings of cardiac failure, but high right ventricular pressure was observed.Postoperatively, the patient is reported to be stable.No additional information is expected.

Manufacturer Narrative

Events of a leaflet tear and leaflet prolapse were reported.The reported tear was confirmed, as cusps 2 and 3 contained tears in the cusp tissue.There was also a fold in cusps 1 and 3, creating incomplete coaptation.A loss of collagen fibers and thinning was observed on all three cusps.A focal outflow thrombus was observed at the base of cusp 1.No acute inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

• 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: 8212435
• MDR Text Key: 131921120
• Report Number: 3001883144-2018-00110
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2018
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 4932065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56