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 Material Split, Cut or Torn (4008)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/19/2018

Event Type  Injury  

Event Description

On (b)(6) 2012, a double valve replace and tricuspid annuloplasty were performed.A 27mm epic valve was implanted in the patient's mitral position.On (b)(6) 2018, re-do mvr was urgently performed due to mitral regurgitation.The leakage was observed at the commissure of the leaflets of the valve.The leaflets were also observed thinning significantly and torn.The physician suspects the leaflets of the valve had uneven thickness.The 6-year-old 27mm epic valve was explanted and a new 27mm epic valve was implanted.Of note, a 19mm trifecta valve was implanted in the aortic position and a 27mm tailor flexible annuloplasty band was implanted in the tricuspid position on the date of the original surgery, (b)(6) 2018.Reportedly, tricuspid regurgitation (tr) was confirmed prior to the reoperative surgical intervention; however, as the leakage was expected to disappear after re-do mvr, treatment was not conducted this time.The patient has been in stable condition postoperatively without any leakage in the tricuspid position.

Manufacturer Narrative

An event of a torn leaflet was confirmed.Gross morphological and histopathological examination revealed a tear in cusp 3.All three cusps contained thinning at the base.Degenerative changes were also observed on all three cusps.Cusp 1 contained fibrous pannus ingrowth on the outflow surface that extended onto the base of the cusp.No acute inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The root causes of the torn leaflet remains unknown.Information from the field indicated that the valve had been implanted for 6 years.

• 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: 8163170
• MDR Text Key: 130310040
• Report Number: 3001883144-2018-00103
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3747234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 44