MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Chest Pain (1776); Occlusion (1984); Rupture (2208); Obstruction/Occlusion (2422); Pericardial Effusion (3271)

Event Date 03/02/2020

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.Per the instructions for use (ifu) cardiovascular injury, such as perforation dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.According to the thv training manuals, risk factors for aortic dissection, hematoma or annular rupture during the tavr procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve and procedural success.In this case, per report, the cause for the coronary occlusion and subsequent annular rupture was related to procedural factors (valve deployment too high and inaccurate measurements).There was no allegation or indication a device malfunction contributed to this adverse 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 our (b)(6) affiliate after valve deployment of a 29mm sapien 3 valve in the aortic position a coronary occlusion was noted.The patient complained of chest pain; however, no regional wall abnormalities were seen on echo and the ecg appeared normal.On fluoro, a root angiogram was performed showing faint opacification of the proximal lad.The patient was intubated, and a balloon angioplasty was performed at the ostium of the left coronary.A 4.5x30mm stent was placed.The patient was stable and transferred for post management care.During post management care an echo was performed and revealed an effusion.The patient became unstable and a pericardiocentesis and ultimately an open procedure was performed.An annular rupture was visualized and repaired.Per report, the cause of the coronary obstruction is that the valve was delivered too high and inaccurate measurement of coronary height on ct.The patient¿s left coronary measured 16cm on ct.

Manufacturer Narrative

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

Manufacturer Narrative

A supplemental mdr is being submitted as additional information was received.The following section of this report has been updated: section h10 (narrative text).Additional information was received: a surgical valve was implanted after the sapien 3 valve was explanted.

Manufacturer Narrative

A supplemental mdr is being submitted as additional information was received.The following section of this report has been updated: section h10 (narrative text).Additional information was received: the sapien 3 valve was explanted at the time of implant.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9879089
• MDR Text Key: 192035967
• Report Number: 2015691-2020-11131
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2020

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: 10/03/2021
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 08/04/2020; 09/21/2020; 07/23/2020
• Supplement Dates FDA Received: 08/28/2020; 09/24/2020; 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR