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

Model Number 9355FS29

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problems Embolism (1829); Injury (2348); No Code Available (3191)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case. please reference related manufacturer report no: 2015691-2018-04274.The edwards sapien xt transcatheter heart valve (thv) systems are indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (rvot) conduit with a clinical indication for intervention and: pulmonary regurgitation = moderate and/or mean rvot gradient = 35 mmhg.  review of the sapien xt transcatheter heart valve with the edwards novaflex+ delivery system pulmonic procedural training manual instruct the operator on the following: when performing valve alignment and fine adjustment, ¿a gap between the thv and distal valve alignment marker may result in difficulty crossing.An overlap cannot be reversed and may prevent proper thv deployment¿.Regarding thv positioning in the landing zone:  ¿place the thv completely within the landing zone¿ and ¿use different fluoroscopic views, if uncertain about positioning¿.During manufacturing, delivery systems undergo multiple 100% inspections per standard operating procedures.These multiple inspections make it unlikely that a defect present during the manufacturing process contributed to the complaint event.Physicians are extensively trained by edwards before they are qualified to use the sapien xt thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.In the pulmonic position difficulty crossing the pre-stent may be due to anatomical and/or procedural factors, including maneuvering through the pre-stent, tortuous anatomy or interaction with other cardiac structures.In this case, the delivery system was not able to pass the overlapping edges of the previously implanted non-edwards pre-stents.There was no allegation of indication of a device malfunction contributing to the procedural difficulty.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.

Event Description

As reported, 29mm sapien xt case by tf approach in pulmonic position.A few month ago, two non-edwards pre-stents 45x28 were implanted in the pulmonic trunk overlapping each other.One stent more towards the pulmonic artery and the other towards the ventricle.The sapien xt valve was prepped and inserted into the patient, however, it was not possible to cross the previously implanted stents.It always got caught at the part where the stents were overlapping each other.Different maneuvers were attempted for 20 min but with no success.It was then decided to implant the valve at the position it where it got caught.During the deployment, the valve moved even more ventricular and ended up half in the stent and have in the ventricle and short time later completely embolized into the ventricle.The patient was transferred to open heart surgery for pulmonary valve replacement.

Manufacturer Narrative

Additional information indicates the patient is okay post savr procedure.

Manufacturer Narrative

Additional information indicates the patient is okay post savr procedure.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7981743
• MDR Text Key: 124674566
• Report Number: 2015691-2018-04275
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2020
• Device Model Number: 9355FS29
• 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: 0
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR