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 Obstruction of Flow (2423); Torn Material (3024)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Mitral Insufficiency (1963)

Event Type  Injury  

Event Description

On (b)(6) 2013, mitral valvuloplasty (mvp) and tricuspid annuloplasty (tap) were performed.On (b)(6) 2013, a 27mm epic valve was implanted.In early (b)(6) 2018, the patient presented at the hospital with symptoms of cardiac insufficiency.On (b)(6) 2018, a leaflet tear caused by pannus ingrowth and calcification was suspected.The device was explanted and replaced with at 25mm carpentier-edwards perimount magna ease mitral heart valve.

Manufacturer Narrative

The reported event of a tear and pannus was confirmed.The reported calcification was not confirmed.Morphological and histopathological examination revealed all three cusps contained tearing in their bases.All three cusp bases were thinned.Fibrous pannus ingrowth was present over the commissure between cusps 2 and 3 on the outflow surface.No 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 tearing remains unknown; however, the tears on cusps 2 and 3 appeared to be consistent with pannus ingrowth on the commissure between the two cusps limiting mobility.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7607495
• MDR Text Key: 111270543
• Report Number: 3001883144-2018-00049
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3840890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2012
• 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: 70 YR
• Patient Weight: 47