MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number SAPIEN 3 UNKNOWN

Device Problems Failure to Conduct (1114); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Arrhythmia (1721); No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), conduction system defects (heart block) which may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, deployment of the prosthetic valve, and the overall tavr procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may provide an explanation for these complications of the tavr procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, atrioventricular conduction disturbances after tavr are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, tavr may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after tavr are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing tavr or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate procedural factors (pressure from the implanted valve on cardiac structures) likely contributed to the events.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required at this time.Reference for article: sammour y , kadri an , gajulapalli rd, et al.Comparison of acute recoil after valve deployment and after post-dilation in patients undergoing transfemoral transcatheter aortic valve replacement with sapien-3 valve.Catheter cardiovasc interv.2020;1¿9.Https://doi.Org/10.1002/ccd.28968.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-12190.

Event Description

As reported through an article, "comparison of acute recoil after valve deployment and after post-dilation in patients undergoing transfemoral-transcatheter aortic valve replacement with sapien-3 valve", a retrospective observational study of patients who underwent transfemoral transcatheter aortic valve replacement (tavr) with sapien-3 valve was performed.Acute recoil at the upper, central, and lower levels of the valve was calculated in both anteroposterior right anterior oblique (rao) and lateral left anterior oblique (lao) views after initial deployment as well as after post-dilation in cases performed at the facility from january 2017 to december 2017.A population of 257 patients were included in the study.Reported clinical outcomes indicated conduction disorder requiring the implant of a new permanent pacemaker (ppm) occurred in 29 patients within 30 days of the tavr procedures.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10168079
• MDR Text Key: 199673187
• Report Number: 2015691-2020-12191
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN 3 UNKNOWN
• 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