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

Model Number UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE.

Device Problems Fracture (1260); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.  the dates of the events are unknown; however, according to the article the study period was from november 2017-june 2018.For this reason, the first day of the reported study period ((b)(6) 2017) was used as the occurrence date.  in this case, the exact valve model number is not available.Therefore, this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an edwards sapien transcatheter heart valves are:  p130009 - edwards sapien xt¿ transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve.  please reference ¿hamandi, mohanad, et al."bioprosthetic valve fracture during valve-in-valve transcatheter aortic valve replacement." (b)(6) medical center proceedings.Taylor & francis, 2020.¿ 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.  investigation results suggest/indicate the cause of the coronary occlusion is unknown, however may be due to patient factors not provided by the author (e.G.Low coronary height, long native leaflets) and/or procedural factors not provided (e.G.Valve deployed too aortic).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 through article "bioprosthetic valve fracture during valve-in-valve transcatheter aortic valve replacement" regarding a single-center study of 12 patients who underwent a bioprosthetic valve fracturing (bvf) valve in valve (viv) transcatheter aortic valve replacement (tavr) from november 2017-june 2018 the following event was found: ¿one case required reoperation to remove the viv due to coronary obstruction.Emergent surgical exploration showed the left ostium to be obstructed by the initial bioprosthetic¿s leaflet.¿.

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.  please reference related manufacturer report no:  2015691-2020-13067.

Manufacturer Narrative

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

• Brand Name: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE.
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10402730
• MDR Text Key: 203157796
• Report Number: 2015691-2020-13065
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

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 Model Number: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 07/23/2020
• Supplement Dates FDA Received: 08/13/2020; 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention