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

Model Number	E100-27M-00
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown if device will be returned.
Event or Problem Description
On (b)(6) 2015, a 19mm trifecta valve was implanted.On an unknown date in (b)(6), the patient visited the hospital and the physician observed a failing valve.On (b)(6) 2018, redo aortic valve replacement and mitral valve replacement was completed.The 19mm trifecta valve was explanted and a 21mm trifecta gt was implanted in the aortic position.The explanted valve was noted to have pannus on the valve.Concomitantly, a 27mm epic valve was implanted in the mitral position.Upon bypass termination, tee observed a directional jet from the mitral valve.Due to surgically related edema, the 27mm epic valve was exchanged for a 25mm epic valve and tee showed good results.The patient is discharged.
Additional Manufacturer Narrative
Event description updated to include additional information was requested, but not provided by the physician or hospital.The event of a directional jet following implant was reported.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.The cause reported event remains unknown.
Event or Problem Description
On (b)(6) 2015, a 19mm trifecta valve was implanted.On an unknown date in (b)(6), the patient visited the hospital and the physician observed a failing valve.On (b)(6) 2018, a returned patient device registration form was received at abbott that indicated a ¿device (epic valve) was implanted, then explanted and replaced with a different size.¿ multiple efforts were made to obtain information and the information made available to abbott was on (b)(6) 2018, redo aortic valve replacement and initial mitral valve replacement was completed.The 19mm trifecta valve was explanted and a 21mm trifecta gt was implanted in the aortic position.The explanted 19mm aortic valve was noted to have pannus on the valve.Concomitantly, a 27mm epic valve was implanted in the mitral position.Upon bypass termination, tee observed a directional jet from the mitral valve.Due to the presence of surgical related edema, the 27mm epic valve was exchanged for a 25mm epic valve and tee showed good results.The patient is discharged.

• 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: 7886886
• Report Number: 3001883144-2018-00081
• Device Sequence Number: 2049640
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

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: 04/08/2022
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00016875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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: 72 YR
• Patient Weight: 76