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

Model Number	E100-33M-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/26/2018
Type of Reportable Event	Death
Event or Problem Description
On(b)(6) 2018, a 33mm epic valve was implanted.On (b)(6) 2019, abbott was made aware from patient device tracking that the patient expired following the surgery on (b)(6) 2018.It was noted the valve was not working as expected.Additional information has been requested.
Additional Manufacturer Narrative
An event of patient death 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.Based on the information made available we have no evidence of a device malfunction.
Event or Problem Description
On (b)(6) 2018, a 33m was implanted and recovered and was discharged.On 08 january 2019, abbott was made aware from patient device tracking that the patient expired at another facility on (b)(6) 2018.Information from the implanting surgeon indicated that the patient was seen on (b)(6) 2018 and had no evidence of a device malfunction was noted.Per the family, it is reported that the "valve was not working as expected' however the facility where the patient died did not provide abbott any information and due to privacy restrictions, abbott was unable to obtain additional information.

• 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.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8276175
• Report Number: 3001883144-2019-00008
• Device Sequence Number: 158716
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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: 01/16/2022
• Device Model Number: E100-33M-00
• Device Lot Number: BR00015242
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/25/2019; 09/30/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/17/2019; 09/30/2019
• 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: Death