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

Model Number 9300TFX29

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

Patient Problem Occlusion (1984)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

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).There are multiple patient factors that could contribute to coronary occlusion by the prosthetic valve or native valve leaflets, including a minimal distance between the native annulus and the coronary ostia, bulky calcification, long native leaflets, and obliterated coronary sinuses.Procedural factors such as torn native leaflet during bav, plaque shift, deployment of the bioprosthetic heart valve too aortic and significant valve over sizing could also contribute to this complication.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).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 training manuals also provide the following tips for detecting risk for left main occlusion: (1) aortogram or tee prior to thv implantation to reveal bulky calcified leaflets; (2) during pre-dilatation, note bulky calcification on valve moving towards ostium on left main; and (3) consider aortogram during valvuloplasty to assess coronary flow.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the obstruction is unknown but the patient¿s low coronary heights most likely contributed to the event.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 by the edwards (b)(6) affiliate, a review of the medical article: "delayed coronary obstruction after transcatheter aortic valve replacement- an uncommon but serious complication" was performed.During balloon valvuloplasty for pre-dilatation with a 25 mm x 40 mm balloon, the left aortic leaflet was displaced toward the left coronary ostium; therefore, we decided to perform coronary protection.A 29 mm sapien xt valve was then implanted.Aortography suggested the presence of stent frames of tavr device close to, but not obstructing, the left coronary ostium.A post-tavr selective angiography also showed a patent left main stem (lms) with timi 3 flow.The patient was discharged uneventfully but a computed tomography follow-up six month after tavr showed new tissue growth near the ostium of lms.The patient declined percutaneous coronary intervention at that time because they continued to do well.Another 5 months passed, the patient was admitted for unstable angina and the lms was stented with a 4.0 mm x 12 mm integrity resolute stent.Post-dilatation with a 4.5 mm non-compliant balloon led to improvement in the angiographic appearance of the stent.Intravascular ultrasound examination demonstrated improvement in minimum lumen area and diameter, but residual ovoid-shaped stented segment discovered at the site of the impingement of stent frames of the tavr device.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC 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: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11057397
• MDR Text Key: 223194361
• Report Number: 2015691-2020-15203
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9300TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2020
• 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: 90 YR