MAUDE Adverse Event Report: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-27M

Device Problems Torn Material (3024); Insufficient Information (3190)

Patient Problem Mitral Regurgitation (1964)

Event Date 11/02/2017

Event Type  Injury  

Event Description

On (b)(6) 2011, a mitral valve replacement (mvr) was performed and a 27mm epic valve was implanted.At the time of follow-up appointment in (b)(6) 2016, the patient's recovery had been uneventful and no issues were identified.In (b)(6) 2017, the patient experienced chest pain and an echocardiogram revealed a leaky mitral valve.A redo mvr is planned and scheduled to be performed (b)(6) 2017, information to confirm the procedure and the patient's status is pending.

Event Description

On (b)(6) 2011, a mitral valve replacement (mvr) was performed and a 27 mm epic valve was implanted.At the time of follow-up appointment in (b)(6) 2016, the patient's recovery had been uneventful and no issues were identified.In (b)(6) 2017, the patient experienced chest pain and an echocardiogram revealed a leaky mitral valve.A redo mvr was performed on (b)(6) 2017.Upon explant a leaflet located in the right coronary cusp was noted to be torn from the stent post.A 27 mm carpentier-edwards perimount magna mitral heart valve was implanted.The patient has been in stable condition postoperatively.

Manufacturer Narrative

Product investigation: the reported event of the of a torn leaflet was confirmed.Gross morphological and histopathological examination found a tear in cusp 1.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No acute inflammation or significant calcifications were found to be present in the valve.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 Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7024676
• MDR Text Key: 91801811
• Report Number: 3001883144-2017-00081
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/08/2015
• Device Model Number: E100-27M
• Device Catalogue Number: E100-27M
• Device Lot Number: 3367510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 12/20/2017
• Supplement Dates FDA Received: 12/04/2017; 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2011
• 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 Age: 84 YR