MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, 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 04/01/2017

Event Type  Injury  

Manufacturer Narrative

The date of the event(s) is unknown.According to the article the date range for this event is from april 2017 to december 2019. for this reason, the first day of the range was used as the occurrence date.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.The edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.Deployment of the sapien 3 valve in a native mitral valve, is not indicated per the labeling; therefore, the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.According to literature review, atrioventricular conduction disturbances after thv procedures are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree and bulkiness of 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, thv may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after thv are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing thv or surgical valve replacement procedures 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 conduction disorder is likely related to the mechanism described above.No additional patient or procedural factors were provided that could help determine a root cause for the conduction disorder.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.Bibliography: lamelas, joseph, and ahmed alnajar."early outcomes for surgical minimally invasive sapien 3 transcatheter mitral valve replacement." the annals of thoracic surgery (2020).

Event Description

A single-surgeon retrospective all-comers mitral valve replacement (mvr) study was published in the journal article ¿early outcome for surgical minimally invasive sapien 3 transcatheter mitral valve¿.The study was between april 2017 to december 2019 and included 16 patients that underwent mvr-tavr with extensive mac and mitral pathology via a minimally invasive right lateral thoracotomy approach under direct vision with valve anchoring sutures to evaluate the early outcomes shown when using the latest generation of balloon-expandable s3 sapien tavr valve prosthesis.There were no conversions to sternotomy.This complaint is for two patients required permanent pacemaker post procedure.

Manufacturer Narrative

This report is 3 of 3 being submitted for this complaint.Reference mfg.Report numbers 2015691-2020-15131 and 2015691-2020-15132.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11042863
• MDR Text Key: 222650496
• Report Number: 2015691-2020-15133
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2020
• 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: 12/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention