MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS TRANSFEMORAL ESHEATH UNKNOWN; INTRODUCER, CATHETER

Model Number ESHEATH UNKNOWN

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and 165 major vascular complication serious injury events for the sapien 3 ultra transcatheter heart valve in the aortic position.The ''time to event'' (tte, in days) for this event was 7.19.Due to the limited information and the data received, edwards cannot confirm which esheath was used in this case, the esheath+ or esheath introducer set.The device identification (di) numbers for edwards expandable introducer sheath + set are (b)(4).The device identification (di) numbers for edwards esheath introducer set are (b)(4).According to the instructions for use (ifu), cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral tavr procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent transfemoral passage of the devices.The ifu contraindicates patients with vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the vascular internal diameters will enable the clinician to determine if the thv can be delivered through the planned access site.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have vessels that are not amenable to percutaneous valve delivery or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device.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 at this time.

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 2 2022 data extract for aortic serious injury events for the sapien 3 ultra valve.This report summarizes 165 vascular complication - major serious injury events for the sapien 3 ultra transcatheter heart valve.The age range for these events are 25-101 years.The breakdown for gender is as follows: 104 females and 61 males.

Manufacturer Narrative

Correction to the exemption number field per fda request on 07/07/2022.

• Brand Name: EDWARDS TRANSFEMORAL ESHEATH UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 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: 15070690
• MDR Text Key: 296287221
• Report Number: 2015691-2022-06890
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Exemption Number: 2016006
• Number of Events Reported: 165
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESHEATH UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• 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): Other
• Patient Age: 79 YR