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

Model Number	E100-27M-00
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Mitral Insufficiency (1963)
Date of Event	01/22/2019
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) 2019, a 27mm epic valve was selected for implant in a mitral valve replacement and cryomaze ablation procedure.Post bypass tee showed grade 2+ intravalvular leakage at the stent post.The valve was removed and a 27mm medtronic mosaic tissue valve was implanted.Bypass time was prolonged by 66 minutes.The patient has been discharged.
Event or Problem Description
On (b)(6) 2019, a 27mm epic valve was selected for implant in a mitral valve replacement and cryomaze ablation procedure.Post bypass tee showed grade 2+ intravalvular leakage at the stent post.The valve was removed and a 27mm medtronic mosaic tissue valve was implanted.Bypass time was prolonged by 66 minutes.The patient has been discharged.
Additional Manufacturer Narrative
The reported event of intravalvular leakage 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 at the time of commercialization.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): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8546936
• Report Number: 3008452825-2019-00205
• Device Sequence Number: 11377010
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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: 10/16/2021
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: 6197899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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: 67 YR