MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 914ESJ

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

Patient Problem Thromboembolism (2654)

Event Date 05/26/2022

Event Type  Injury  

Event Description

As reported through the (b)(6) tavi registry, a 23mm sapien 3 valve was transfemorally deployed in the aortic annulus.Right after tavr, the patient developed left femoral artery thromboembolism and occlusion was observed.Blood flow was restored by thrombus aspiration and balloon angioplasty.As per follow up, since there was no resistance during sheath insertion and removing, it is thought that tortuosity may have been contributed to the event.The outcome was determined as recovered.

Manufacturer Narrative

Per the instructions for use (ifu), thrombosis and embolization of air, calcification or thrombus are potential adverse events associated with transcatheter aortic valve replacement and bioprosthetic heart valves.According to the mayo clinic, some causes for thromboembolism not associated with invasive procedures include advanced age, atherosclerosis, cancer, previous mi, heart failure, dm, htn, a sedentary lifestyle, certain medications, and smoking.It is the natural tendency of the body to form a clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove the clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause of the reported event was unable to be determined but may have been due to procedural factors and or patient factors not provided.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.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 monthly, 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 ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• 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: 14807483
• MDR Text Key: 295067420
• Report Number: 2015691-2022-06389
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

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: 914ESJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female