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 Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Mitral Regurgitation (1964); Cusp Tear (2656)

Event Date 09/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the epic valve was explanted due to mitral regurgitation (mr) and replaced with a 25mm, non-sjm mechanical heart valve.During explant, aortic regurgitation (ar) occurred twice.After the epic tissue valve was explanted, one of the cusps was torn along the stent base while the posteromedial side remained attached to the stent.The physician alleged that the event was caused by the epic tissue valve as the patient did not demonstrate infective endocarditis or other findings.The patient was stabilized postoperatively.The event date was an estimation.

Event Description

During explant, aortic regurgitation (ar, grade 4) occurred twice.

Manufacturer Narrative

(b)(4).The 27mm epic valve was returned to sjm for analysis.The results of the investigation concluded there were tears on cusps 1 and 2, a thin layer of fibrin on the inflow and outflow surfaces of cusps 1 and 3, and fibrin deposition within the cuspal tissue on all the cusps.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 fibrin formation and tears 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 fibrin formation and tears remains unknown.

Event Description

On (b)(6) 2014, an epic valve was explanted due to mr and replaced with a 25mm, non-sjm mechanical heart valve.During explant, aortic regurgitation (ar) was noted on two occasions.After explantation of the epic valve it was noted one of the cusps tore along the stent base from the a1-p1 commissure (anterolateral commissure) while the posteromedial commissure side remained attached to the stent.The physician alleged that the event was caused by the epic tissue valve as the patient did not demonstrate infective endocarditis or other findings.The patient was stabilized postoperatively.

• 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: 4202681
• MDR Text Key: 4978509
• Report Number: 3001883144-2014-00024
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/16/2016
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3744582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• 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): Required Intervention