MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

Model Number 2900

Device Problems Degraded (1153); Torn Material (3024)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Although bioprosthetic valves have been proven to have excellent long term durability, failure does occur in a small number of valves.Replacement of a bioprosthetic valve over time is more likely due to structural valve deterioration (svd) which occurs as a result of stenosis (from calcification or host tissue overgrowth), dehiscence, fibrosis or non-calcific degeneration.Stenosis, which develops progressively over time, can be due to a number of issues.Additionally, there can be a number of potential known and unknown patient related contributing factors.Svd, a common reason for bioprosthesis explant or reoperation, encompasses multiple failure modes, including calcific and non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes, occurring singularly or concomitantly, may contribute to stenosis and/or regurgitation.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular stenosis.The device was not returned for evaluation, as it remained implanted.Therefore, the root cause for the degeneration, tear, regurgitation, and stenosis remains indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.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 this (b)(6) year-old patient with an unknown 27 mm pericardial aortic valve showed degeneration, leaflet tear, stenosis, and regurgitation approximately five (5) year after the implant.The patient was hospitalized due to an episode of heart failure due to this failing valve and a semi-urgent valve in valve procedure was successfully performed with a 29mm transcatheter valve.The patient was expected to be discharged the following day.It was also reported that the patient had possible endocarditis, although vegetations were never seen, four months after initial implant of the 27 mm pericardial valve.

Manufacturer Narrative

Additional manufacturer narrative: supplemental report was submitted to include the device information that was received and the dhr review.Updated device manufacture date.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.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7221658
• MDR Text Key: 98347968
• Report Number: 2015691-2018-00281
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2016
• Device Model Number: 2900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR