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

Model Number E100-23A

Device Problems Gradient Increase (1270); Leak/Splash (1354); Occlusion Within Device (1423); Material Deformation (2976)

Patient Problems Aortic Regurgitation (1716); Arrhythmia (1721); Atrial Fibrillation (1729); Tachycardia (2095); Heart Failure (2206); Stenosis (2263)

Event Date 01/08/2015

Event Type  Injury  

Event Description

On (b)(6) 2014, an aortic valve replacement with this 23 mm sjm epic valve was performed due to calcific aortic stenosis.In (b)(6) 2014, the patient was admitted to icu for atrial fibrillation with tachyarrhythmia.Sinus rhythm was restored and normal prosthetic function was confirmed.The patient was asymptomatic and functional class nyha ii for the next 2 to 3 months.Late (b)(6) 2014, the patient was admitted to the hospital with signs and symptoms of exacerbated left ventricular heart failure in the presence of sinus rhythm with preserved ejection fraction.Prosthetic aortic valve stenosis was diagnosed.Echocardiography documented an elevated gradient, thickened prosthetic cusps, and aortic regurgitation.On (b)(6) 2015, the epic valve was explanted and replaced with a 19 mm sjm regent mechanical valve.The patient was reported to be stable and discharged.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The results of this investigation concluded all cusps were fibrotically thickened.There was outflow thrombus on all cusps.The thrombus created folds in all cusps, which retracted the cusps and resulted in incomplete coaptation.Special stains were negative for organisms, and no significant calcifications were present.There was no evidence found to suggest the cause of the fibrin and thrombus 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 STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• 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: 4516945
• MDR Text Key: 5444845
• Report Number: 3001883144-2015-00008
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2017
• Device Model Number: E100-23A
• Device Catalogue Number: E100-23A
• Device Lot Number: 4118777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2013
• 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: 76 YR