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

Model Number E100-23A

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 05/08/2019

Event Type  Injury  

Event Description

Related manufacturer reference number: 3005334138-2022-00109.This event is being conservatively reported as the cause of the event was not confirmed.It was reported that on (b)(6) 2019, a 23m and a 27mm epic stented porcine heart valve w/flexfit system were successfully implanted for a mitral valve replacement (mvr) and aortic valve replacement (avr) and also a maze procedure.Post procedure, the patient's blood pressure (bp) dropped to 57/40 mmhg in the intensive care unit (icu).The patient was treated with noradrenaline and epinephrine, which did not improved the patient's blood pressure.It was said that the patient had a cardiac tamponade, the patient required another emergency thoracotomy the same day.The following day, (b)(6) 2019, the patient was recovering with the following vitals: temperature 36.7¿ , heart rate 70 bpm, respiration 20 bpm, bp 120/70 mmhg.On may (b)(6) 2019, x-ray reveled multiple exudation in both lungs, and pleural effusion on the both sides, especially at the hilum pulmonis.It was noted that the patient had pulmonary edema.The patient was treated with anti-infection, hemostasis, analgesia, protecting gastric mucosa, reducing phlegm and nourishment.The patient recovered in stable condition and was discharged home on (b)(6) 2019.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of cardiac tamponade, multiple exudation in both lungs, pleural effusion and pulmonary edema after the valve was implanted was reported.A more comprehensive assessment could not be performed as the device remains implanted 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13619627
• MDR Text Key: 287105502
• Report Number: 3005334138-2022-00108
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: E100-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2022
• 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): Hospitalization; Required Intervention