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

Model Number SAPIEN 3 UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Complete Heart Block (2627)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The dates of the events are unknown.The first day of the first month of the range used as the occurrence date, (b)(6) 2015.Article reference: eftychiou, christos, nicolaos eteocleous, ioannis zittis, krikor simamonian, antonis ioannou, pantelitsa loukaidou, aliki ntaka et al."outcomes of transfemoral transcatheter aortic valve implantation (tavi) and predictors of thirty-day major adverse cardiovascular events (mace) and one-year mortality." hellenic journal of cardiology (2020).The investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6), per the article ¿outcomes of transfemoral transcatheter aortic valve implantation (tavi) and predictors of thirty-day major adverse cardiovascular events (mace) and one-year mortality¿, data of 178 patients who received a sapien 3 valve at a single center from january 2015 to march 2020 were reviewed.During the study period, 4 patient had new pacemaker implantations.

Manufacturer Narrative

This is one of five manufacturer reports being submitted for this article.Please reference related manufacturer report numbers: 2015691-2020-15334, 2015691-2020-15335, 2015691-2020-15336, 2015691-2020-15338.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 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.The cause for the conduction disturbances could not be determined with the limited information provided by the authors.However, patient factors not provided and/or the mechanisms described above are likely contributing factors for the event.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.

• Brand Name: SAPIEN 3 UNKNOWN
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11098717
• MDR Text Key: 224798361
• Report Number: 2015691-2020-15337
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention