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

Model Number	ESP100-21-00
Medical Device Problem Codes	Obstruction of Flow (2423); Biocompatibility (2886)
Health Effect - Clinical Codes	Dyspnea (1816); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3001883144-2021-00091
• Device Sequence Number: 19992828
• Product Code: LWR
• UDI-Device Identifier: 05414734055635
• UDI-Public: 05414734055635
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR