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

Model Number 9300TFX23A

Device Problems Calcified (1077); Leak/Splash (1354)

Patient Problems Aortic Valve Stenosis (1717); Stenosis (2263)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Per the instruction for use (ifu), valve stenosis is a potential risks associated with pulmonic valve replacement and bioprosthetic heart valves.Valve stenosis may result in symptoms such as sob and decreased exercise tolerance, which may be accompanied by an increased gradient across the valve.This could be due to early calcification of the leaflets, host tissue overgrowth or in rare cases, a non-functioning leaflet.In this case, there was no indication or allegation that the ¿stenosis¿ was due to a device malfunction.Per medical records, the proximal ¿stenosis¿ of the sapien xt valve was due to the conical shape of the valve stent (19mm on the proximal end vs 25mm on the distal end).The conical shape was caused by a thick layer of calcium between the sapien xt valve stent and the prosthetic homograft ring, which is preventing further expansion of the stent.In addition, this 23mm valve appears to be now undersized for this growing patient.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.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.  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.

Event Description

As reported through the edwards lifesciences clinical study cxt, the physicians were unable to estimate the pulmonary conduit gradient or rv pressure by tte at the 2 year study follow-up visit and decided to perform a diagnostic right ventricle catheterization due to concern for right ventricle-pulmonary artery conduit stenosis.During the study, the 23mm sapien valve was found to be working well, just undersized for this growing patient with proximal ¿stenosis¿ due to conical shape of the valve stent.Angiogram showed that the valve had trivial insufficiency that was catheter induced.The valve stent appears conical in shape and measured 19 mm at the proximal portion and 25mm distally. there is a thick layer of calcium between the valve stent and the prosthetic homograft ring, which is preventing further expansion of the stent.A 22mm x 4 cm atlas balloon was prepped and delivered over the wire, into position across the pulmonary valve.The balloon was inflated on one occasion to a maximum of 25 atm, with notable improvement in the caliber of the prosthetic valve stent.Angiogram showed no change in the degree of insufficiency as compared to prior to valvuloplasty.No perivalvular leak.The sapien valve measured now 22mm proximally.There were no complications during the procedure.The patient was discharged in good condition.

Manufacturer Narrative

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: 9241844
• MDR Text Key: 166140928
• Report Number: 2015691-2019-03979
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2019
• Device Model Number: 9300TFX23A
• 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: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 19 YR
• Patient Weight: 79