MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM; TISSUE, HEART-VALVE

Model Number 8300AB

Device Problems Incomplete Coaptation (2507); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); No Code Available (3191)

Event Date 08/10/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as patient authorization is required.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Based on the information received the cause of the event cannot be determined.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported a patient initially implanted with a 27mm valve for 1 day had an explant procedure completed for unknown reasons.A 29mm 3300tfx valve was implanted in the patient.The current patient status is unknown.

Manufacturer Narrative

H10.Additional manufacturer narrative: edwards received additional information through follow up with the healthcare provider.Supplemental report submitted to update b5, b7, d7, e4 (uf#0300650000-2019-8014), and f10.Valve dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate prosthetic valve implantation in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.In rare occasions, during the initial implant procedure, a suture or sutures may tear through the annulus requiring valve exchange or repair with standard surgical techniques and does not lead to serious injury or death.In this case, the valve was explanted on post-operative day 10 due to dehiscence with a severe paravalvular leak caused by broken sutures.Based on the available information, the root cause of the dehiscence remains indeterminable.However, it is likely that patient related factors and procedural factors contributed to the 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

It was reported via the implant patient registry that a 27mm valve was explanted after an implant duration of 10 days due to dehiscence with a severe paravalvular leak.Per obtained medical records, at initial implant, the 27mm valve was inspected and found to be in excellent position.The patient tolerated the procedure well and was taken to the icu in stable condition.Postoperatively the patient was found to have a pvl with rocking of the aortic prosthesis that required redo avr.The patient required also required amiodarone for atrial fibrillation.Intraoperatively, the valve was found to be dehisced with a broken suture or corknot that wasn¿t intact.It was unclear what may have caused the break.A 29mm pericardial aortic valve was implanted in replacement.The patient was reported to have recovered and was discharged.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8983306
• MDR Text Key: 161242510
• Report Number: 2015691-2019-03380
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2021
• Device Model Number: 8300AB
• 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: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR