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	E100-23A-00
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	Stenosis (2263)
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, a 23 mm epic stented porcine aortic heart valve was implanted in the pulmonary position.When the patient came off of bypass, pulmonary stenosis was noted.The patient was placed back on bypass and the valve was explanted and replaced with another epic stented porcine aortic heart valve to resolve the event.While inspecting the explanted valve, a pinched crease and some leaflet redundancy within in the valve leaflets.The patient is recovering and doing well.
Event or Problem Description
On (b)(6) 2020, a 23 mm epic stented porcine aortic heart valve was implanted in the pulmonary position.When the patient came off of bypass, pulmonary stenosis was noted.The patient was placed back on bypass and the valve was explanted and replaced with another epic stented porcine aortic heart valve to resolve the event.While inspecting the explanted valve, a pinched crease and some leaflet redundancy within in the valve leaflets.The physician alleges that the stenosis was caused by the native leaflet of the pulmonary valve and was not caused by the epic valve and did not feel this was a valve issue.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is recovering and doing well.
Additional Manufacturer Narrative
An event of pulmonary stenosis was reported.One leaflet was noted to be folded under non-physiological conditions.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.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.
Additional Manufacturer Narrative
An event of pulmonary stenosis was reported.One leaflet was noted to be folded under non-physiological conditions.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.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.Please note, per the instructions for use, artmt "the safety and effectiveness of the epic and epic supra valves has not been established for the following specific populations: patients requiring pulmonic or tricuspid valve replacement".

• 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: 11015431
• Report Number: 3001883144-2020-00124
• Device Sequence Number: 753045
• Product Code: LWR
• UDI-Device Identifier: 05414734055536
• UDI-Public: 05414734055536
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 06/04/2021
• Device Model Number: E100-23A-00
• Device Catalogue Number: E100-23A-00
• Device Lot Number: BR00013334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 02/10/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/09/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR