MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS AXELA SHEATH / EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number ESHEATH UNKNOWN

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

Patient Problems Vascular System (Circulation), Impaired (2572); Unspecified Vascular Problem (4441)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 32 events of major vascular complication the sapien 3 ultra transcatheter heart valve in the aortic position.The ¿time to event¿ (tte, in days) for this event was 3.09.The device identification (di) numbers for edwards axela sheath is (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 ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the thv can be delivered transfemorally.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 femoral/iliac vessels that are not amenable to the trans-femoral approach 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, specific 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

This report summarize 32 events of major vascular complication serious injury events for the sapien 3 ultra transcatheter heart valve in the aortic position for august 2020.The age range for these events is from 58 to 93.The breakdown for gender is as follows: 12 males and 20 females.August 2020 data extract includes data provided by acc for q1 (january 1 and march 31).

Manufacturer Narrative

Supplemental report to add noe statement in b5 section, and provide d5 and h6 information.

Event Description

This report summarize 32 events of major vascular complication serious injury events for the sapien 3 ultra transcatheter heart valve in the aortic position for (b)(6) 2020.

• Brand Name: EDWARDS AXELA SHEATH / EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10891947
• MDR Text Key: 218009009
• Report Number: 2015691-2020-14658
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 32
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESHEATH UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other