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

Model Number 9600TFX23J

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

Patient Problem Occlusion (1984)

Event Date 11/26/2020

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 in patients with bulky calcified aortic valve leaflets in close proximity to the coronary ostia.In addition, it warns that caution should be exercised in implanting a bioprosthesis in patients with clinically significant coronary artery disease.  coronary obstruction can result in myocardial ischemia or infarction due to obstruction of the coronary blood flow and may require intervention (e.G.Percutaneous coronary intervention (pci)).    there are multiple patient factors that could put the patient at risk for coronary flow obstruction during the tavr procedure, including significant underlying coronary artery disease and bulky calcification of the native leaflets and root.Displacement of calcium deposits with embolization of debris into one of the arteries, or aortic dissection with continuity of the rupture into the intima of one of the coronary ostia, can result in this complication.  the edwards thv 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.  in this case, there was no allegation or indication a device malfunction contributed to this adverse event.Per medical opinion the cause of the reported event was due to calcification.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 an edwards lifesciences affiliate in (b)(6), upon implant of a 23 mm sapien 3 valve in the aortic position via transfemoral approach the patient was observed to have a coronary artery occlusion.Percutaneous coronary intervention was performed using percutaneous cardiopulmonary support to resolve the obstruction.Per medical opinion, the event was likely due to calcification of the aortic valve and calcification of the annulus.

• Brand Name: EDWARDS SAPIEN 3 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: 11041705
• MDR Text Key: 222658146
• Report Number: 2015691-2020-15116
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: 9600TFX23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Date Device Manufactured: 05/27/2020
• 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: 84 YR
• Patient Weight: 45