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	E100-29M-00
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, a 29mm epic valve was implanted in the mitral position.On (b)(6) 2018, the patient presented with symptoms of chronic heart failure.On (b)(6) 2018, the device was explanted and replaced with another 29mm epic valve (serial number unknown).Upon explant, one of the leaflets was observed to be torn.The patient is reported to be in good condition.
Additional Manufacturer Narrative
The reported event of a torn cusp could not be confirmed."symptoms of chronic heart failure" was also reported.The results of the investigation are inconclusive since the device remains implanted and 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.

• 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: 7955609
• Report Number: 3008452825-2018-00351
• Device Sequence Number: 1387234
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: 05414734055598
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2018

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: Health Professional
• Device Expiration Date: 05/03/2019
• Device Model Number: E100-29M-00
• Device Catalogue Number: E100-29M-00
• Device Lot Number: 5098808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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: 71 YR
• Patient Weight: 84