MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problem Malposition of Device (2616)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-02715.Per the instructions for use (ifu), valve malposition and embolization are known potential complications associated with the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition/embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native valve stenosis.Deployment of the sapien 3 valve in a (native mitral valve, native tricuspid valve, previously implanted tricuspid surgical valve, previously implanted tricuspid ring, pulmonic valve) is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tvr procedure.The ifu cautions that the safety and effectiveness have not been established for patients with bulky calcified 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.In this case, the cause of the valve moving forward to the left pulmonary artery blocking the right pulmonary artery may be related to patient factors (large pulmonic annulus) and/or procedural factors (delivery system balloon ruptured during valve deployment).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, during a transfemoral transcatheter pulmonic valve replacement (tpvr) with a 29mm sapien 3 valve, post deployment, the valve moved forward into the left pulmonary artery blocking the right pulmonary artery.A decision was made to convert to surgical procedure and a surgical valve was replaced.The patient is stable post procedure.

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, product code, pma number, or other missed or incorrect information).A correction to section g4 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN 3 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 11741253
• MDR Text Key: 252262535
• Report Number: 2015691-2021-02717
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)221102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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: 11/02/2022
• Device Model Number: 9600TFX29A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 11/29/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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