MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 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); Ischemia (1942); Renal Failure (2041); Tachycardia (2095); Thrombocytopenia (4431); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/15/2020

Event Type  Injury  

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 patient underwent a coronary artery bypass grafting.(cabg) and implant of a 29 mm epic stented porcine heart valve w/flexfit system for a mitral valve replacement (mvr).Post procedure, the patient was transferred to the intensive care for further management.The patient condition was reported to be unstable, presenting with hypotension and tachycardia.Chest tube output was moderate and bloody.Despite the treatment of prbcs and protamine to reverse the effect of the heparin, the patient's chest tube output remain steady with bloody drainage the next morning.The patient was treated with prothrombin and fibrinogen.The patients central venous pressure improved however the blood pressure was still low.That same morning, on (b)(6) 2020, the decision was made to take the patient for an exploratory thoracotomy.During this procedure, a small clot was discovered inside the pericardium.The bleeding was described as a "diffused oozing" with no obvious source of bleeding determined.That evening, the patients hgb was reported to be low, 6g/dl.The patient was transfused 2 units of prbcs.The hgb was checked post the 2 units and it was 6.4 g/dl.On the afternoon of (b)(6) 2020, the patient developed ischemia of their right lower extremity, this was the access site of the intra-aortic balloon pump (iabp).An ultrasound of the patients limbs revealed multiple areas of arterial plaque on both sides of the limbs, mild to moderate stenosis of the left common femoral artery and severe stenosis of the anterior tibial artery.The patient was treated with papaverine.Early morning on (b)(6) 2020, the patients coagulation levels were determined to be low.The patient was given 400ml of fresh frozen plasma (ffp) for treatment, 12 hours later, the patient required 2 units of platelets.Vascular surgery consulted and performed a bed-side removal of the femoral artery thrombus and surgically repaired performing a femoral artery patch angioplasty.On (b)(6) 2022, the right lower extremity was mottled and cyanotic indicating an obstruction of blood flow.The limb also demonstrated poor muscle tension, tone and pedal pulses were not appreciated.Laboratory testing resulted the patients myoglobin, serum creatinine and lactic acid were abnormal.On (b)(6) 2020 renal failure was determined and continuous renal replacement therapy (crrt) was initiated.That evening the patients coagulation state declined and the patient was given another 400 ml of ffp.On (b)(6) 2020, the patients blood pressure dropped to 40/30 mmhg and the vasoactive agents were bolused but the patients hypotension was refractory to treatment and remained unstable.The crrt was turned off.At 10:20, the platelets were only 30 * 10^9/l.2 units of the platelets were transfused.The patient was unresponsive and intubated.The patient was under a "save state", critically ill with multi-organ failure.The cardiotonic drugs and vasopressors was given intermittently.The relatives got him discharged.No additional information has been provided.

Manufacturer Narrative

The reported event of heart failure decompensation and multi organ failure could not be confirmed.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, 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: 13860107
• MDR Text Key: 287668308
• Report Number: 3005334138-2022-00242
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 04/12/2022
• 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; Required Intervention