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

Model Number E100-25M

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Anemia (1706); Arrhythmia (1721); Bacterial Infection (1735); Hypoxia (1918); Sepsis (2067); Thrombocytopenia (4431); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2020, a 25mm epic stented porcine heart valve with flexfit system was implanted during a mitral valve replacement (mvr).Patient also had tricuspid valve repair and radiofrequency ablation.The patient was transferred to the intensive care unit (icu).The patient had a low platelet count, so two units of platelets were transfused.On (b)(6) 2020, the drainage liquid was noted to be more than the normal amount.The patient had a low hemoglobin, and so two units of red blood cells (rbc) were transfused to treat the anemia.On (b)(6) 2020, the echocardiogram showed poor heart function.The ventricular wall motion was very poor, especially at the apex parts.The troponin (tni) level was high, and it was considered stress cardiomyopathy.The patient was treated with an intra-aortic balloon pump (iabp).Antibiotics were given due to elevated white blood cell count (wbc) and c-reactive protein (crp).Medication for liver protection was also given due to increased liver enzyme level.On (b)(6) 2020, the heart function gradually recovered, though the ventricular wall motion at the apex was still poor.The patient was still on iabp.On (b)(6) 2020, the patient had a lower liver enzyme level and a high level of bilirubin.Patient was diagnosed with cholestasis, and medications were given for treatment.On (b)(6) 2020, the patient's heart function further recovered and the tni level decreased.However, the patient developed atrial fibrillation, hypoxemia, and respiratory acidosis.Medications and a second trachea cannula were given.On (b)(6) 2020, the patient had low blood pressure, frequent ventricular premature beat (vpb), and moderate tricuspid regurgitation.The patient was given more antibiotics.The patient was on ventilator-assisted ventilation, iabp, and continuous renal replacement therapy (crrt).The patient had pulmonary edema.The patient's lactic acid levels kept increasing and the blood glucose level was low.Patient had decreased body temperature, fluctuating blood pressure, decreased heartrate, frequent vpbs, and ventricular tachyarrhythmia.The patient's hemoglobin decreased, and two units of rbcs were given.The patient was also given anti-inflammatory therapy.On (b)(6) 2020, the patient's lactic acid level kept increasing, and the patient was critically ill.The patient developed cyanosis and coagulation disorder.The patient had a low hemoglobin, critical d-dimer, hypohepatia, and infection.There was thrombogenesis in subclavian vein and jugular vein, and two units of rbc and plasma were given.The patient entered multiple organ failure and septic shock.At this time after many treatments and medications, the patient's relatives voluntarily gave up further saving treatment for the patient.No additional information was provided.

Manufacturer Narrative

Correction: h6, upon review, the 25mm epic valve should not have been submitted as a medical device report (mdr) as the additional information indicates that post-operation echocardiogram (echo) results suggested the valve was working as intended.It was noted that the patient situation was not good during the hospitalization.There was no allegation of malfunction against the valve.Prior to the implant procedure, the patient's cardiac function was poor (new york heart association (nyha) iii), and the patient had infectious endocarditis and anemia before the surgery.

Event Description

Subsequent to the initially filed report, additional information was received that the patient was discharged and passed away the next day on (b)(6) 2020.Prior to the implant procedure, the patient's cardiac function was poor (new york heart association (nyha) iii), and the patient had infectious endocarditis and anemia before the surgery.The death was not assumed to be related to the device.It was considered the death was related to the comprehensive reasons of uncontrolled infectious endocarditis, the poor cardiac function, and the irreversible anemia.The post-operation echocardiogram (echo) results suggested the valve was working as intended.It was noted that the patient situation was not good during the hospitalization.There was no allegation of malfunction against the valve.

• 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: 13892161
• MDR Text Key: 287845162
• Report Number: 3005334138-2022-00258
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-25M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2022
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention