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

Model Number 8300AB27

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Hematoma (1884)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).The device was not returned to edwards for evaluation as it remains implanted.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.Attempts to retrieve additional information is in process.If additional information is received a supplemental mdr will be submitted.Paravalvular leak in intuity valves 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.In this case the cause remains indeterminable.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 notification that an a 27mm aortic pericardial valve was observed to have paravalvular leak (pvl) after an implant duration of one year, two months.The patient was considered for a re-do surgery to plug the pvl.As reported, the cardiologists suspected the pvl existed at the index procedure but was under reported in the routine follow up echo before discharge.Of note; there was a haematoma that has since resolved, that might have resulted in the evolution of the pvl.

Manufacturer Narrative

Corrected data: 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: 9654661
• MDR Text Key: 177931098
• Report Number: 2015691-2020-10329
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: 8300AB27
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR