MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500

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

Patient Problems Calcium Deposits/Calcification (1758); Cardiopulmonary Arrest (1765); Multiple Organ Failure (3261); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/03/2020

Event Type  Injury  

Manufacturer Narrative

Partial or total occlusion or obstruction of the coronary ostia is a recognized complication of an aortic valve replacement and, less frequently, from mitral valve replacement.It is typically the result of a technical error during valve implant and not related to a product malfunction.However, partial or total occlusion of the ostia, if unrecognized, can result in angina, myocardial infarction, acute peri-operative right, left or bi-ventricular dysfunction and/or death.In this case, the device was explanted and replaced with the same model valve, one size smaller.The patient also underwent cabg.The root cause of this event cannot be conclusively determined.However, patient and/or procedural related factors may have contributed to this event.There has been no allegation of a device malfunction.Multiple attempts have been made for product return.There has been no response at this time.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no manufacturing issues that would have impacted this event. edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Through implant patient registry, it was learned that a patient with a 23mm 11500a aortic valve was explanted at implant due to coronary artery obstruction.The explanted valve was replaced with a 21mm 11500a valve.Per the medical records, the native aortic valve was replaced due to severe calcification and thickening of the leaflets causing restricted motion.The 23mm aortic valve was explanted due to coronary artery obstruction and global lv hypokinesis was observed.It was assumed that the left-right commissure posts were obstructing the slit-like orifice to the rca/lcx.The was some damage the annulus post explant.The abnormal coronary artery was unroofed prior to implant of the 21mm aortic valve.However, after implantation the patient underwent an unplanned on-bypass cabg to treat rca ischemia due to suspected air/emboli.Post-operative course was complicated by cardiopulmonary arrest during the preparation of an exploratory laparotomy to evaluate free air in the abdomen/elevated lactase on pod #2; there was right ventricular dysfunction post open-heart massage.  the patient underwent two sternal washout procedures and had multiple organ failure. the patient underwent right sided tunneled hemodialysis catheter placement prior to being discharged to acute care facility on pod #22.   edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.

• Brand Name: INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: amritha srinivasan ; 1 edwards way; mle-2; irvine, CA 92614 ; 9492504062
• MDR Report Key: 10781569
• MDR Text Key: 214544485
• Report Number: 2015691-2020-14234
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Date Device Manufactured: 10/15/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 102