MAUDE Adverse Event Report: AGA MEDICAL CORPORATION EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E100-33M-00
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 33 mm epic mitral tissue valve was sized and chosen for procedure.After coming off bypass and reviewing the valves function during an intra-operative echo, the valve appeared to have some eccentric mr through the valve.The surgeon decided to go back on bypass and remove the valve.The valve was replaced with a 31mm epic mitral valve and the procedure was completed without incident.Patient is stable and recovering.
Additional Manufacturer Narrative
An event of a cusp remaining "stuck to the stent post" and resultant regurgitation was reported.A portion of one cusp of the received valve had been previously removed, consistent with damage during histopathological examination, precluding functional examination.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This was inclusive of inspections for proper cuspal coaptation and hemodynamic performance.The cause of the reported event 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): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10734126
• Report Number: 2135147-2020-00448
• Device Sequence Number: 3180382
• 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): 01/08/2021

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: 05/27/2024
• Device Model Number: E100-33M-00
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00025213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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