MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV); AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX23J

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Udi number: (b)(4).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 patient had a low lmt ostium height of 7.8 mm.Due to risk of coronary occlusion, a coronary stent was preventively deployed.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 our affiliates in (b)(6), after deployment of a 23mm sapien 3 valve in the aortic position via transfemoral approach, a native leaflet was close to the ostium of the left main trunk (lmt).Distortion of the ostium was confirmed by intravascular ultrasound (ivus).Therefore, a coronary stent was preventively deployed.The patient had no wave change on electrocardiogram (ecg) and no ischemic symptom were observed post valve implant.The lmt ostium height was 7.8 mm.The sinus of valsalva (sov) was narrow at 25-27 mm.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9741246
• MDR Text Key: 190131629
• Report Number: 2015691-2020-10636
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: 10/23/2021
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention