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

Model Number ESP100-21-00

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that an (b)(6) year old patient implanted with an epic supra valve w/flexfit on (b)(6) 2021, presented with symptoms of congestive heart failure (chf) reporting dyspnea, regurgitation, and high gradients during a follow-up appointment in the clinic.A clot was confirmed on the valve.At the discovery of the thrombus, the patient was not on any anticoagulant or antiplatelet therapy.The patient was put on heparin and then switched to coumadin.The physician reported the valve remained implanted.The patients mean gradient has decreased into the 20s.No additional information was provided.

Manufacturer Narrative

An event of thrombus was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 12013737
• MDR Text Key: 256725891
• Report Number: 3001883144-2021-00091
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055635
• UDI-Public: 05414734055635
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: ESP100-21-00
• Device Catalogue Number: ESP100-21-00
• Device Lot Number: BR00025885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR