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

Model Number E100-29M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 03/13/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on (b)(6) 2021, a 23mm epic stented porcine heart valve w/flexfit system was implanted in the aortic position and a 29mm epic stented porcine heart valve w/flexfit system was implanted into the mitral position.There were no complications noted during the implant procedure.On (b)(6) 2021, increased liquid drainage was noted and the patient was treated with albumin, rehydration salts, fibrinogen and thrombin-antithrombin complex however the hemostatic effect was not good.The bloody drainage has reached to 1550ml and the patient's hemoglobin dropped to 6.8g/dl and blood pressure dropped th 75/4 5mmhg.A pleural effusion and pericardial effusion was confirmed.An exploratory thoracotomy was performed blood clots along with widespread oozing was found in the pericardium with an obvious active bleed.The patient was transfused 2 units of red blood cells and 400ml of plasma.It was thought that the bleeding was caused by a heart injury from the separation of the pericardium.The patient was improving after the exploratory thoracotomy.On (b)(6) 2021, the patient was discharged from the hospital.Additional information was requested but cannot be obtained.Manufacturer report number: 3005334138-2022-00188.

Manufacturer Narrative

An event of "increased liquid drainage", "pleural effusion", "pericardial effusion", " blood clots along with widespread oozing", reduced hemoglobin and reduced blood pressure was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.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
• Type of Device: 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
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13693013
• MDR Text Key: 286937587
• Report Number: 3005334138-2022-00189
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-29M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: E100-23A
• Patient Outcome(s): Hospitalization; Required Intervention