MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA) FG ESP200 EPIC 2.0 SUP 27MM PMP BR MFR; SURGICAL TISSUE VALVES

Model Number	ESP200-27
Medical Device Problem Codes	Backflow (1064); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Valvular Insufficiency/ Regurgitation (4449)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a 27mm epic supra valve was implanted on (b)(6) 2021.Post implant echocardiogram (echo) showed severe central regurgitation and what seemed as if the non coronary leaflet was not moving on echo.The decision was made to go back on bypass and remove the valve.The 27mm epic supra valve was removed, no issues noted upon inspection.The annulus was re-sized and a decision to place a 25mm epic plus supra was made.Post procedure, the new valve is moving well with a gradient of 6mm.Patient stable, no additional information was provided.
Additional Manufacturer Narrative
Additional information sections: d9, g3, h1, h2, h3, h6, h10.Added h6 device code : 1064 - backflow.The reported event of 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.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with a non-structural valve dysfunction.A 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, a smaller, 25mm valve was implanted, so the valve could have been inappropriately sized, which could explain the observed intra-operative valvular dysfunction.However the exact cause of the observed intra-operative valvular regurgitation cannot be conclusively determined.

• Brand Name: FG ESP200 EPIC 2.0 SUP 27MM PMP BR MFR
• Common Device Name: SURGICAL TISSUE VALVES
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13351427
• Report Number: 3001883144-2022-00004
• Device Sequence Number: 16555979
• Product Code: LWR
• UDI-Device Identifier: 05415067033154
• UDI-Public: 05415067033154
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021/S047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 09/20/2022
• Device Model Number: ESP200-27
• Device Catalogue Number: ESP200-27
• Device Lot Number: BR00030420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male