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

Model Number ESP100-21

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Endocarditis (1834); No Consequences Or Impact To Patient (2199)

Event Date 12/29/2018

Event Type  Injury  

Event Description

On (b)(6), a 21mm epic valve was implanted in the aortic position due to aortic valve stenosis.During a follow-up visit 3 months later, the patient was confirmed to have severe regurgitation.The physician believed the event to be patient-prosthesis mismatch due to the incorrect size valve was implanted as it was related to the sizer set.At the explant, it was discovered that the patient had endocarditis.The device was replaced with a 23mm epic valve and the patient is reported to be stable.

Manufacturer Narrative

The reported event of a "small hole" on the device could not be confirmed.No anomalies or damage were noted on the valve stent or cusps.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.The cause of the reported event could not be conclusively determined.

Event Description

It was initially reported that the reported valve was explanted after an implant period of 3 months.Based on a follow-up conversation with the physician, it was confirmed that during device preparation, the device was opened and a small hole was observed on the device.The device was exchanged to complete the procedure.The device was never implanted in the patient.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• 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
• MDR Report Key: 8414794
• MDR Text Key: 138641397
• Report Number: 3001883144-2019-00017
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: ESP100-21
• Device Catalogue Number: ESP100-21
• Device Lot Number: BR00013493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention