MAUDE Adverse Event Report: EDWARDS LIFESCIENCES; RING, ANNULOPLASTY

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Tricuspid Regurgitation (2112); Regurgitation (2259)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was unable to be reviewed as the device serial number is unknown.There may be cases where a transcatheter valve is placed through a previously placed annuloplasty ring for recurrent regurgitation and/or stenosis.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs as a result of progression of disease and is typically not related to a device malfunction.In this case, it was alleged that the rigidity, open shape, and open configuration of the ring may lead to imperfect positioning of the valve, resulting in severe pvl.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Through review of a medical article, the following event was identified as pertaining to an edwards device: a patient with a 26-mm ring implanted in the tricuspid position underwent a valve-in-ring procedure after an implant duration of approximately 2 years due to recurrent severe tricuspid regurgitation.Transthoracic echocardiography showed a moderately dilated right ventricle with preserved function.Considering the patient¿s history of breast radiotherapy, a difficult recovery from her previous surgery, and the calculated risk scores (society of thoracic surgeons predicted risk of mortality [stsprom], 9.6%; european system for cardiac operative risk evaluation [euroscore] ii, 8.34%), the heart team decision was an off-label use of an edwards transcatheter heart valve for transfemoral valve-in-ring implantation.A 26-mm valve was implanted within the edwards ring.As reported, post-implantation, tricuspid regurgitation remained severe, but from a different location, and a surgical valve replacement was performed on day 4.Recovery was slow.The patient remained hospitalized for more than 1 year and was discharged with dialysis 3 times per week.

Manufacturer Narrative

Reference capa-20-00141.

• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9973491
• MDR Text Key: 190643616
• Report Number: 2015691-2020-11501
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR