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 Problems Material Perforation (2205); Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Anemia (1706)

Event Type  Injury  

Event Description

On (b)(6) 2017, a 27mm epic valve was implanted.Approximately 12 months post implant, the patient presented with anemia and echocardiogram revealed impeded leaflet mobility of the valve cusp.On (b)(6) 2018, the valve was explanted and replaced with a on-x mechanical heart valve.Upon explant, thickening of the cusp with severe pannus ingrowth, thrombus on leaflet cusp and leaflet perforation were reported.The patient is reported to be stable.

Manufacturer Narrative

The reported event of impeded leaflet mobility, calcification, pannus and perforation were confirmed.The reported vegetation and thrombus could not be confirmed.Regurgitation was also reported.Morphological and histopathological examination found calcifications in all three cusps.Fibrous pannus ingrowth was present on the inflow surfaces of cusps 1 and 2, and a small amount straddled the commissure between cusps 1 and 3 on the outflow surface.Cusp 1 contained a perforation in its mid portion.There was thinning and loss of collagen fibers of cusp 1.The calcification and pannus limited the mobility of all three cusps.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root cause of the reported event remains unknown; however, calcification and pannus are known events associated with tissue heart valves.

Event Description

On (b)(6) 2017, a 27mm epic valve was implanted and the patient was discharged on (b)(6) 2017.On (b)(6) 2018, the patient presented at the hospital with loss of appetite and fatigue, and was admitted to the hospital after structural valve deterioration was confirmed.An echocardiogram performed on (b)(6) 2018, revealed impeded leaflet mobility due to leaflet thickening, calcification, vegetation on the anterior leaflet side, and grade iii mitral regurgitation.On (b)(6) 2018, the valve was explanted and replaced with a on-x mechanical heart valve.Upon explant, thickening of the cusp with severe pannus ingrowth, thrombus on leaflet cusp and leaflet perforation were reported.The patient is reported to be stable.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7828520
• MDR Text Key: 118621354
• Report Number: 3001883144-2018-00073
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

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: 09/28/2020
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: BR00009685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 DA