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

Model Number E100-21A

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Sepsis (2067); Hypernatremia (2242); Respiratory Failure (2484); Thrombocytopenia (4431)

Event Date 11/23/2019

Event Type  Death  

Manufacturer Narrative

An event of hypernatremia, dyspnea, respiratory failure, thrombocytopenia, sepsis, "coagulation function was continued to declined", "blood pressure continued to decline", pulmonary infection, and patient death 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.

Event Description

Related manufacturer reference number: 3007113487-2022-00019.This event is being conservatively reported for death as no additional information was able to be obtain from the site.It was reported on (b)(6) 2019 a patient underwent a aortic valve replacement and a mitral valve replacement.The patient received a 21mm aortic epic stented porcine heart valve w/flexfit system and a 29mm mitral epic stented porcine heart valve w/flexfit system.On 23 november the patient developed decreased urine output due to the patients hypernatremia.The patient developed increased dyspnea and respiratory failure and that patient was intubated.On (b)(6) 2019, chronic renal replacement therapy (crrt) was initiated to treat the hypernatremia and because the patient was hemodynamically unstable.On (b)(6) it was determined the patient developed thrombocytopenia with a blood platelet count of 20 x 10 * 9/l and diagnosed with sepsis.On (b)(6) the patients coagulation function was continued to declined, the prothrombin time (pt) was 49.6 seconds, pt% was 15.0%, inr was 4.32, active partial thromboplastin (aptt) was 66.2sec, fasting blood glucose (fbg) was 3.0 10g/l, d-dimer was 3638 ng/ml, and fibrinogen degradation product (fdp) was 27.16 ug/ml.The patient was treated with vitamin k1 and 400ml plasma for treatment.On (b)(6) 2019 the patient continued to decline despite the high dose vasopressors the patients blood pressure continued to decline.It was reported the patient had passed away due to a pulmonary infection and sepsis.Additional information was requested but could not be provided by the site.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13311204
• MDR Text Key: 284166157
• Report Number: 3007113487-2022-00018
• 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
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• 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
• Patient Outcome(s): Death