MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 8300AB21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

Aortic tears, or a tear of the aortic wall, may occur as a complication of cardiac surgery involving a diseased aortic root.Additional causes of aortic tears or a tear of the aortic wall may be related to the use or misuse of the edwards intuity valve.These aortic injuries are life threatening conditions that require urgent intervention with suture repair, pericardial patch repair or aortic root replacement.Intervention to repair an aortic injury or subsequent death would be reportable if there is evidence or an allegation the use or misuse of the edwards intuity valve caused or contributed to the event.Such events could be related to improper seating at the time of device implant and/or oversizing of the edwards intuity valve.In this case, there was no evidence of oversizing but there is a possibility that the edwards intuity valve contributed to the aortic injury.Based on the available information, the root cause of the event remains indeterminable.However, it is likely that patient and procedural factors contributed to the event.If new information is received, a supplemental report will be submitted.The device was not available for return per follow up.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified 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

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.In this case, it was reported via the implant patient registry that an 21mm aortic valve was explanted at implant due to aortic root tear.A new 21mm valve was implanted in replacement.The patient was transferred to cvicu in critical condition.The patient as discharged to a skilled nursing facility in stable condition on pod #20.No additional details were provided.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified 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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-0014.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7943680
• MDR Text Key: 123065822
• Report Number: 2015691-2018-04102
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Model Number: 8300AB21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR