MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 8300AB

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); No Information (3190)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was reported to be unavailable.The device history record (dhr) review could not be performed as the serial number is unknown.Paravalvular leak (pvl) refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue.It may occur as a result of a lack of appropriate sealing of the valve at the annulus.The most common reason for pvl is inadequate debridement of a calcified annulus or attempted implant with improper valve seating.Pvl is not a result of device malfunction.There may be small pvls identified intra-operatively or post-operatively which do not require any intervention.Most cases of pvl noted intra-operatively are corrected with standard surgical techniques during the initial implant procedure and do not lead to serious injury or death.The cause of the event cannot be determined; however, surgical technique and patient factors may have 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

Edwards received information a 27mm aortic pericardial valve implanted in the aortic position was explanted after an unknown implant duration due to pvl.As reported, an important leak was observed at the level of the non-coronary sinus and two plugs were implanted in the attempt to reduce or repair the leak.As the pvl did not solve, decision was made to remove the aortic valve.The explanted device was replaced with an 27mm aortic valve.The patient was noted as to be hospitalized in stable condition after the procedure.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM (AORTIC VALVE MODEL 8300AB)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9836303
• MDR Text Key: 190958551
• Report Number: 2015691-2020-10976
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150036/S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Hospitalization; Life Threatening
• Patient Age: 60 YR