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

Model Number 9600TFX23A

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by implant patient registry, post operative day (pod) 1 of a 23mm sapien 3 valve in a pre-existing pulmonic conduit the valve in the pulmonic position, the s3 valve was explanted due to st changes caused by compression of one of the branches feeding the lad, which was later found to be coming off the right coronary cusp.Post deployment, the team struggled to get good images of the left coronary system due to the double pre-stents with the sapien 3 valve inside.The proximal left coronary system was difficult to visualize, and the ekg showed st changes.The patient was hemodynamically stable, however, the decision was made to move to the floor and monitor the patient and troponin levels.One of the branches feeding the lad was later found to be coming off the right coronary cusp, which the team believes must have been compressed causing the st changes.Over night, the troponin levels continued to elevate.The decision was made to bring the patient to the operating room and remove the pre-stent and sapien 3 valve then sew in a surgical valve.This was performed and the patient left the operating room in stable condition.

Manufacturer Narrative

Per the instructions for use (ifu), coronary flow obstruction is a potential adverse event associated with the tpvr procedure.The ifu cautions that assessment for coronary compression risk prior to valve implantation is essential to prevent the risk of severe patient harm.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 including a minimal distance between the transcatheter heart valve (thv) landing zone and the coronary artery.The edwards thv training manuals advise the operator on pre-procedure assessment of the pulmonic thv target implantation site, aortic valve, root, and coronary anatomy.Physicians are extensively trained by edwards before they are qualified to use the 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.In this case, the cause of the coronary artery compression cannot be confirmed.However, there was no allegation or indication a device malfunction contributed to this adverse event.Per report, it was difficult to get good images of the left coronary system for coronary compression assessment due to the patient having double pre-stents in the landing zone.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.

• 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: 12524371
• MDR Text Key: 273085133
• Report Number: 2015691-2021-05318
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)220429
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: 9600TFX23A
• Device Catalogue Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2020
• 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