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

Model Number	E100-33M-00
Medical Device Problem Codes	Backflow (1064); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
On (b)(6) 2020, an epic mitral valve was selected for implant.During the procedure, regurgitation was observed due to incomplete coaptation of the valve.The device was exchanged intraoperatively.The patient remained hemodynamically stable throughout the procedure.There was a clinically significant delay.
Event or Problem Description
On 29 june 2020, an epic mitral valve was selected for implant.During the procedure, regurgitation was observed due to incomplete coaptation of the valve.The device was exchanged intraoperatively.The patient remained hemodynamically stable throughout the procedure.There was a clinically significant delay.A user facility medwatch report was submitted under the following reference number: (b)(4).The user facility medwatch report received stated that there was abnormality in the leaflet of the valve per the surgeon.
Additional Manufacturer Narrative
An event of incomplete coaptation of the epic stented porcine heart valve w/flexfit system and regurgitation was reported.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 10305722
• Report Number: 3001883144-2020-00076
• Device Sequence Number: 2577392
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2024
• Device Model Number: E100-33M-00
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00024491
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 74