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

Model Number 9300TFX23A

Device Problems Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Occlusion (1984)

Event Date 04/13/2018

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tavr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia.Coronary occlusion can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G.Pci).  the edwards thv training manuals advise the operator on pre-procedure assessment of the aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the transcatheter heart valve (thv) in on-label procedures.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The physician is instructed to evaluate this risk early in the patient screening process in all patients.The following factors should be considered: degree of calcification on leaflets, annulus to coronary ostia distance, length of the valve leaflet, width of the valsalva sinuses, movement of the leaflets during bav, patency of coronaries during bav, and expanded height of the intended thv.The edwards sapien 3 transcatheter heart valve and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis, or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve, who are judged by a heart team, including a cardiac surgeon, to be at low or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 1% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).  the use of a sapien 3 valve in a pulmonic thv in the aortic position is not indicated per the labeling; therefore, the device instructions for use and procedural training manual do not provide direction for the use of the device in this application.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Per a review of the article, the root cause may have been a narrowing of the coronary ostia by one of the valve anchoring sutures.A review of edwards lifesciences risk management documentation was performed for this case.  the reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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.Sinha, sanjay, et al."application of transcatheter valves for aortic valve replacement in pediatric patients: a case series." catheterization and cardiovascular interventions (2019).

Event Description

As reported through article "application of transcatheter valves for aortic valve replacement in pediatric patients: a case series", the tavr procedure was performed on pediatric patients with a total of 6 patients receiving sapien xt and sapien 3 valves.One (b)(6) patient received a 23 mm sapien xt valve within a pre-existing non-edwards pulmonic thv valve (implanted approximately 2 years prior) via median sternotomy and it was noted that "the ostium of the left main coronary artery was noticeably distorted.The narrowing of the coronary ostia was an unexpected consequence of valve inflation." the physician was able to relieve the narrowing by removing one of the valve anchoring sutures.

Manufacturer Narrative

Please reference related manufacturer reports nos: 2015691-2019-04200 and 2015691-2019-04203.

Manufacturer Narrative

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

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect common device name and product code.A correction to field d.2 is being submitted in this supplemental report.

• 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
• 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: 9317810
• MDR Text Key: 166609511
• Report Number: 2015691-2019-04206
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• 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
• Patient Age: 6 YR
• Patient Weight: 24 KG