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

Model Number E100-29M

Device Problem Torn Material (3024)

Patient Problem Aortic Insufficiency (1715)

Event Date 11/24/2017

Event Type  Injury  

Event Description

On (b)(6) 2014, a mitral valve replacement was performed and this 29 mm epic tissue valve was implanted.On (b)(6) 2017, the valve was explanted due to a rupture observed in one of the cusps.A 31 mm biocor pericardial heart valve (model: b30-31m; sn: (b)(4)) was implanted.The patient was reported to be in stable condition.

Manufacturer Narrative

Product investigation: the reported event of a "rupture observed in one of the cusps" was confirmed.Gross morphological and histopathological examination found cusps 1 and 2 were torn.Cusp 2 appeared to be folded in on itself.No acute inflammation or significant calcifications were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; 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 31310 -260; BR 31310-260
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7199274
• MDR Text Key: 97507098
• Report Number: 3001883144-2018-00014
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2017
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Other Device ID Number: 05414734027533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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: 51 YR
• Patient Weight: 70