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	E100-31M-00
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 31mm epic mitral valve was selected for implant.It was reported that the implant went well and the valve was tested with saline and the leaflets were coapting.As the patient was coming off bypass, all leaflets were observed to be functioning and coapting, however a large central jet was observed on echo.Closer examination showed that one of the leaflets appeared to be prolapsing.No paravalvular leak was observed, no perforation of any leaflet was observed, and no leaflet was suture looped.The patient was taken fully off of bypass and fully pressurized and the valve did not improve.The epic valve was intraoperatively explanted and a competitor's 25mm magna ease valve was successfully implanted.Upon explant of the epic valve, the physician reported that one of the leaflets was short of full coaptation.The patient was hemodynamically stable throughout the procedure.The physician does allege a clinically significant prolonged procedure time due to the exchange.The patient was reported to be recovering well.
Additional Manufacturer Narrative
An event of central jet and leaflet prolapse was reported.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.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with non-structural valve dysfunction.Non-structural valve dysfunction (nsvd) is a known potential complication of valve replacement surgery as outlined in the instructions for use.Nsvd is commonly attributed to implant-related technical factors such as inappropriate sizing or positioning, entrapment by suture, stent deformation, or mishandling of the leaflet tissue.In this case there is no evidence of inappropriate sizing, entrapment by suture, or stent deformation that could explain the observed intra-operative valvular dysfunction.Temporary distortion of the stent due to external forces following aortic closure, where the stent is not permanently deformed, may also potentially explain the observed intraoperative valvular dysfunction.However, since it is not possible to determine whether there was any temporary intra-operative stent deformation and none of the other potential causes for nsvd could be confirmed, the exact cause of the observed intra-operative valvular regurgitation cannot be conclusively determined.
Event or Problem Description
On (b)(6) 2020, a 31mm epic mitral valve was selected for implant.It was reported that the implant went well and the valve was tested with saline and the leaflets were coapting.As the patient was coming off bypass, all leaflets were observed to be functioning and coapting, however a large central jet was observed on echo.Closer examination showed that one of the leaflets appeared to be prolapsing.No paravalvular leak was observed, no perforation of any leaflet was observed, and no leaflet was suture looped.The patient was taken fully off of bypass and fully pressurized and the valve did not improve.The epic valve was intraoperatively explanted and a competitor's 25mm magna ease valve was successfully implanted.Upon explant of the epic valve, the physician reported that one of the leaflets was short of full coaptation.The patient was hemodynamically stable throughout the procedure.The physician does allege a clinically significant prolonged procedure time due to the exchange.The patient was reported to be recovering well.User facility medwatch report received that states "implanted 31mm st.Jude epic mitral tissue valve showing malfunction on echo after implantation.It was explanted with a new tissue valve implanted.Fda safety report id # (b)(4).

• 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: 10608254
• Report Number: 3001883144-2020-00094
• Device Sequence Number: 2385971
• Product Code: LWR
• UDI-Device Identifier: 05414734055604
• UDI-Public: 05414734055604
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 11/20/2020
• Report Date (Section F): 09/25/2020

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: 03/15/2024
• Device Model Number: E100-31M-00
• Device Catalogue Number: E100-31M-00
• Device Lot Number: BR00024247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/23/2020; 11/04/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/27/2020; 11/20/2020
• 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
• Patient Age: 74 YR
• Patient Weight: 94
• Date Report Sent to FDA: 09/25/2020