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

Model Number E100-27M

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Ventricular Fibrillation (2130)

Event Date 01/13/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, the patient's oxyhemoglobin saturation dropped to 80% and a tracheal intubation was placed.The patient blood pressure (bp) increased after a does of vasoactive agents but the liver and kidney function were poor.On (b)(6) 2019, the patient was given renal dialysis because of acute renal failure.On (b)(6) 2019, the patient was experiencing ventricular fibrillation (vf) with a heart rate (hr) of 205bpm and the patient's heart stopped beating.The bp was noted detected and patient was unconsciousness and external chest compressions were started along with epinephrine was administrated the patient's heartbeat was recovered however, the bp was very low (66/34mmhg).It is thought that vf was not due to the implant procedure of the aortic and mitral valves.The patient was than discharged voluntarily upon the family's request.At discharged both the aorta and mitral epic valves were performing as intended.Additional information was requested but cannot be obtained.Manufacturer report number: (b)(4).

Manufacturer Narrative

An event of acute renal failure, ventricular fibrillation, increased blood pressure were 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, 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: 13258136
• MDR Text Key: 285697893
• Report Number: 3007113487-2022-00014
• 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: 01/31/2022

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
• Device Operator: Health Professional
• Device Model Number: E100-27M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 01/31/2022
• 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: E100-21A
• Patient Outcome(s): Required Intervention