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

Model Number TF SHEATH UNKNOWN

Device Problems Material Too Rigid or Stiff (1544); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Rupture (2208); Vascular System (Circulation), Impaired (2572); Pericardial Effusion (3271)

Event Date 03/01/2014

Event Type  Injury  

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2019-04505, 2015691-2019-04506, 2015691-2019-04507.This report is for the 6 patients experienced vascular complications, four of which were considered major vascular complications.The date of the events is unknown.According to the article the date range for this event(s) is from march 2014 and may 2018 using an edwards sapien (xt and 3).For this reason, the first day of the range was used as the occurrence date.This report represents the 4 patients reported to have experienced major vascular complications.This is one of four manufacturer reports being submitted for this case.In this case, the exact device model number is not available.Therefore this report will reflect an unknown edwards introducer sheath.The possible pma numbers associated with an edwards introducer sheath are listed below.P110021k093877 retroflex 3¿ introducer sheath; p130009 - edwards expandable introducer sheath set (associated with sapien xt); p140031- edwards expandable introducer sheath set (associated with sapien 3).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 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 sapien 3 valve 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.There was no allegation or indication a device malfunction contributed to this adverse event.In this case, reporting and capture are being done conservatively.No additional patient or procedural factors were provided that could help determine a root cause.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.Article reference: nielsen ne, baranowska j, bramlage p, baranowski j.Minimizing the risk for left ventricular rupture during transcatheter aortic valve implantation by reducing the presence of stiff guidewires in the ventricle.Interact cardiovasc thorac surg.2019 sep 1;29(3):365-370.Doi: 10.1093/icvts/ivz107.Pubmed pmid: 31135035.

Event Description

As reported through the review of the medical article: " minimizing the risk for left ventricular rupture during transcatheter aortic valve implantation by reducing the presence of stiff guidewires in the ventricle".Corresponding author jacek baranowski, 316 consecutive patients who underwent tavi at a single international center between march 2014 and may 2018 using an edwards sapien (xt and 3) transcatheter heart valve were included in this retrospective observational study.Procedural characteristics and outcome data were recorded according to valve academic research consortium-2 criteria at 30 days.Procedural success was achieved in all patients (100%).The following events were identified during the study period: 1 patient had a pericardial effusion due to an annular rupture.5 patients required a new pacemaker.3 patients suffered a stroke during the 30-day outcome period.6 patients experienced vascular complications, four of which were considered major vascular complications.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS UNKNOWN INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9429014
• MDR Text Key: 170208125
• Report Number: 2015691-2019-04508
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF SHEATH UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other