MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-19

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Mitral Regurgitation (1964); Organ Dehiscence (2502)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Postoperatively, in (b)(6) 2014, aortic regurgitation was observed.On an unknown date in 2014, mitral valve regurgitation was detected secondary to presumed stiffened leaflet(s) and mitral valve replacement was scheduled.On (b)(6) 2014, mitral valve replacement was performed.The intraoperative echocardiogram revealed turbulent aortic regurgitation beneath the epic valve.Also, the non-coronary cusp of this epic valve interfered with the mitral valve.A dehiscence was observed on the left coronary cusp near the commissure between left and right coronary cusp.All cuspal tissue appeared normal and no calcification was observed on the cusps.The causal relationship between aortic regurgitation and mitral regurgitation was unknown.There were no signs of infection.This epic valve was explanted and replaced with a 19 mm tissue valve from another manufacturer in the aortic position and a 25 mm tissue valve from another manufacturer was implanted in the mitral position.The patient was recovering postoperatively.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded fibrous pannus ingrowth on all cusps, tears in cusps 1 and 3, and a thin layer of fibrin on the outflow surface of cusp 3.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the pannus formation, tears, and fibrin formation were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 3131 0-26; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4414783
• MDR Text Key: 5163307
• Report Number: 3001883144-2015-00003
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2016
• Device Model Number: ESP100-19
• Device Catalogue Number: ESP100-19
• Device Lot Number: 3860818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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: 82 YR
• Patient Weight: 39