MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; HEART-VALVE, REPLACEMENT

Device Problems Perivalvular Leak (1457); Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/01/2010

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.While the majority of affected patients are asymptomatic, it can lead to significant morbidity including heart failure and hemolytic anemia.Pvl can occur in the mitral and aortic position for similar reasons, including technique and patient related factors.The type and cause of regurgitation varies depending upon multiple factors.Typically, mild regurgitation is not unusual after initial valve replacement, and is usually tolerated by patients.Often moderate to high regurgitation requiring re-operation in the immediate post-operation period is due to procedural related issues and is unrelated to the device.Regurgitation which develops progressively over time can be due to number of issues including patient related factors or structural valve deterioration.A definitive root cause could not be determined; however, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Through review of medical article: "intermediate-term outcome of 500 consecutive rapid-deployment surgical aortic valve procedures" authors martin andreas et al, the following events were identified as pertaining to edwards devices: 5 valve explants due to pvl (2 early and 3 late).

Manufacturer Narrative

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

• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8094498
• MDR Text Key: 128042767
• Report Number: 2015691-2018-04834
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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