MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9300TFX23A

Device Problems Migration or Expulsion of Device (1395); Improper Flow or Infusion (2954); Migration (4003)

Patient Problems Pulmonary Dysfunction (2019); Pulmonary Insufficiency (2022)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As per presentation presented at the tct 2018 conference, ¿sapien double trouble¿.Ignorance is bliss¿, a (b)(6) patient with history of tetralogy of fallot heart defect and surgical repair performed multiple times.The patient presented with severe pulmonary insufficiency (pi) and was declared not to be a surgical candidate or not an ecmo/support candidate.The patient received two sapien xt valves in the pulmonary branch arteries.Approximately 90 days post procedure, the patient was ¿allegedly less symptomatic¿, but images showed "clearly migrated valve and stent complex" and decreased right ventricle (rv) volumes on ct.Initially, a pulmonic thv procedure was performed using two sapien xt valves because the patient's pulmonic valve was too large for a thv to be placed directly in the valve.The plan, from the start of the procedure, was to put one valve in each of the two pulmonic artery branches.The case went as planned.

Manufacturer Narrative

The edwards sapien 3 thv is currently under investigation in the united states for pulmonic application.Per the pulmonic ifu, the edwards commander delivery system and accessories are indicated for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions: dysfunctional rvot conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention, and: regurgitation: = moderate regurgitation, and/or stenosis: mean rvot gradient = 35 mmhg.Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter valve replacement.According to the ifu, correct sizing of the thv into the non-compliant rvot conduit or failing bioprosthesis is essential to minimize risks.Too small of a valve may result in paravalvular leak, migration, or valve embolization; whereas too large of a valve may result in residual gradient (patient-prosthesis mismatch) or rvot rupture.According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the landing zone at the pulmonary artery.Less-than-severe and non-uniformly distributed calcification, incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.The edwards thv patient screening manual advises the operator on pre-procedure assessment, taking into consideration the degree and distribution of pulmonary vasculature disease.The procedural didactic instructs the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct sizing, alignment and positioning of the device are emphasized as key factors to the placement and fixation of the device.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.As per presentation, the exact cause for valve dislocation cannot be determined; however, the event could be attributed to undersizing of the valve and/or not pre-stenting the pulmonary arteries.Despite multiple attempts, no other information was forthcoming.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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7991137
• MDR Text Key: 124564849
• Report Number: 2015691-2018-04325
• 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: other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 11/29/2018; 07/23/2020
• Supplement Dates FDA Received: 11/29/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR