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

Model Number E100-29M

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964)

Event Date 11/27/2018

Event Type  Injury  

Event Description

On (b)(6) 2011, a mitral valve replacement (mvr) was performed due to prosthetic valve dysfunction associated with mitral regurgitation (mr).The holder was attached while parachuting the device into the annulus.This 29mm epic valve was implanted in the patient's mitral position.In (b)(6) of 2018, the patient presented with respiratory discomfort.An echocardiogram was performed which revealed severe mitral regurgitation with one of the anterior cusps suspected to be torn halfway.On (b)(6) 2018, a re-do mvr was performed and the device was explanted.Upon explant, a leaflet tear was confirmed.The device was replaced with a 29mm masters valve.The patient was stable postoperatively and later discharged.The physician stated that the device had been implanted in a (b)(6) patient and contributed to the early structural valve deterioration (svd).

Manufacturer Narrative

An event of mitral regurgitation due to a torn leaflet was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined; however, per the physician "the device had been implanted in a 60 year old patient and contributed to the early structural valve deterioration (svd)".

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• MDR Report Key: 8459431
• MDR Text Key: 140144708
• Report Number: 3001743903-2019-00003
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2014
• Device Model Number: E100-29M
• Device Lot Number: 3367463
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 52