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

Model Number	E100-31M-00
Medical Device Problem Codes	Backflow (1064); Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
A 31mm epic mitral was implanted in a double valve procedure and when the patient came of bypass, the leaflets were not coapting.This created a mitral regurgitation (mr) and he was forced to go back on pump and remove the valve.A unknown edwards valve was implanted.
Additional Manufacturer Narrative
Additional information: d10, g4, h1 h2, h3, h6 and h10.The reported event incomplete coaptation and regurgitation could not be confirmed.No anomalies were found with the valve cusps, and functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.
Event or Problem Description
A 31mm epic mitral was implanted in a double valve procedure and when the patient came of bypass, the leaflets were not coapting.This created a mitral regurgitation (mr) and he was forced to go back on pump and remove the valve.A unknown edwards valve was implanted.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• MDR Report Key: 10809075
• Report Number: 3008452825-2020-00619
• Device Sequence Number: 3501421
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: E100-31M-00
• Device Catalogue Number: E100-31M-00
• Device Lot Number: BR00023520
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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: Hospitalization; Required Intervention