MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN XT VALVE UNKNOWN; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number SAPIEN XT UNKNOWN

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

Patient Problem Arrhythmia (1721)

Event Date 11/22/2016

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 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 arrhythmias could not be determined with the limited available information, however is likely related to the mechanisms described above.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.

Event Description

As reported by our affiliates in (b)(4), per the article ¿early outcomes of percutaneous pulmonary valve implantation using the edwards sapien xt transcatheter heart valve system¿, a multinational, multicentre, retrospective, observational registry analysis of patients who underwent percutaneous pulmonary valve implantation (ppvi) using the edwards sapien xt valve was performed.46 patients were enrolled and the majority had tetralogy of fallot as the underlying diagnosis and stentless xenograft as the most common rvot anatomy.Of the 46 patients, four patients had arrhythmias requiring pacing, drugs or cardioversion.Reference: nikolaus a.Haas, et al., early outcomes of percutaneous pulmonary valve implantation using the edwards sapien xt transcatheter heart valve system.International journal of cardiology (2017).

Manufacturer Narrative

The event date was inadvertently entered incorrectly.

Manufacturer Narrative

This is three of four manufacturer reports being submitted for this article.Please reference related manufacturer report numbers: 2015691-2017-04487, 2015691-2017-04488, 2015691-2017-04490, 2015691-2017-04491.

• Brand Name: SAPIEN XT VALVE UNKNOWN
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7141368
• MDR Text Key: 95589630
• Report Number: 2015691-2017-04490
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SAPIEN XT UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• 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): Required Intervention