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 E100-27M

Device Problem Perivalvular Leak (1457)

Patient Problems Atrial Fibrillation (1729); Death (1802); Dyspnea (1816); Hemoptysis (1887); Tricuspid Regurgitation (2112); Heart Failure (2206); Cusp Tear (2656)

Event Date 11/10/2014

Event Type  Injury  

Event Description

In 2010, the patient was implanted with a 27mm epic stented tissue mitral valve.Four years later, the patient presented with shortness of breath and hemoptysis.A 2d echo and doppler revealed atrial fibrillation, a moderate to severe paravalvular leak (gradient 38/11mm hg) and severe tricuspid regurgitation.The patient was admitted for surgical intervention, at the time of procedure, tee confirmed one of the cusps of the mitral valve was torn.The mitral valve was explanted, the annulus sized to 27mm and a new 27mm epic tissue valve was implanted using interrupted pledgeted mattress sutures.A tricuspid valve repair was also performed.Following the procedure, mild tricuspid regurgitation was observed.On the day following surgery, the patient died secondary to right heart failure.

• 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 ; 6517564470
• MDR Report Key: 4310090
• MDR Text Key: 5197289
• Report Number: 3001883144-2014-00030
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PP040021
• 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
• Report Date: 11/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/22/2017
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 4523927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 60