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

Model Number	ESP100-25-00
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Regurgitation (1716)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 25mm epic supra valve was implanted.After removing the patient from by-pass, a post-implant tee showed aortic valve regurgitation and significant paravalvular leakage.The patient was returned to by-pass and the epic valve was removed and replaced with a mechanical valve.The user comments the cor-knot did not fire properly.The patient is reported to be stable.
Additional Manufacturer Narrative
An event of leakage/regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicates that, "the cor-knot did not fire properly and resulted in pvl.".
Event or Problem Description
On (b)(6) 2018, a 25mm epic supra valve was implanted.After removing the patient from by-pass, a post-implant tee showed aortic valve regurgitation and significant paravalvular leakage.The patient was returned to by-pass and the epic valve was removed and replaced with a 27mm masters series mechanical heart valve.The user commented the cor-knot did not fire properly and resulted in pvl.The patient is reported to be stable.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• 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: 7671274
• Report Number: 3008452825-2018-00216
• Device Sequence Number: 11408246
• Product Code: LWR
• UDI-Device Identifier: 05414734055659
• UDI-Public: 05414734055659
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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: No Information
• Device Expiration Date: 11/17/2018
• Device Model Number: ESP100-25-00
• Device Catalogue Number: ESP100-25-00
• Device Lot Number: 4906323
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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: 59 YR