MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; REPLACEMENT HEART VALVE

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

Patient Problem Aortic Regurgitation (1716)

Event Date 06/06/2012

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned to edwards for evaluation as it remained implanted.The device history record (dhr) was not able to be reviewed as the device information was not provided.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.As the device was not returned for evaluation, the root cause for the degeneration, regurgitation, and leaflet tears remains indeterminable.However, it is likely that patient related factors and the progression of the underlying valvular disease pathology contributed to the event.No corrective action is applicable to this case; however, 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.No corrective or preventative actions are required.

Event Description

Edwards reviewed the article "combined venoarterial extracorporeal membrane oxygenation and transcatheter aortic valve implantation for the treatment of acute aortic prosthesis dysfunction in a high-risk patient" by amedeo pergolini et al, published in the portuguese journal of cardiology, (b)(6) 2016.Abstract: we describe the case of a patient with acute bioprosthesis dysfunction in cardiogenic shock, in whom hemodynamic support was provided by venoarterial extracorporeal membrane oxygenation, and successfully treated by transcatheter aortic valve implantation.Within the context of this article a (b)(6) male with a 23mm bioprosthetic aortic valve implanted in the aortic position, underwent surgery for a valve in valve intervention after an implant duration of approximately 6 (six) years due severe aortic regurgitation secondary to valve degeneration and leaflet tears (ef 20%).A 26 mm transcatheter valve was implanted within the disabled 23mm valve through a transapical approach.The patient was noted as to be discharged two weeks after the procedure.At three-month follow-up, the patient was in stable clinical conditions, in new york heart association class ii, with improved left ventricular ejection fraction (about 40%).

Manufacturer Narrative

Event date: (b)(6) 2012.

• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; one edwards way; m/s t&d 2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 5938162
• MDR Text Key: 54265153
• Report Number: 2015691-2016-02695
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR