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

Model Number 920ES29

Device Problem Kinked (1339)

Patient Problem Vascular Dissection (3160)

Event Date 10/29/2014

Event Type  Injury  

Event Description

During the transfemoral tavr procedure, upon removal of the 20fr esheath, the patient sustained an iliac dissection.This patient had a pre-existing aaa stent graft (aneurx from 2004) in place.He had mld of 8.6 mm in the externals and 7.3 mm in the cfa's, with no calcification and moderate tortuosity.The team decided on a 29 mm valve, 20 fr e-sheath, sapien xt, transfemoral approach, right side.The case went well overall with some resistance pushing the sheath through the aaa graft limbs.The valve was deployed with excellent result.While pulling out the e-sheath a kink was noticed.It was decided to pull the delivery system out then advance the dilator through the sheath to straighten the kink.However, when the delivery system was pulled out the nosecone got stuck in the kink.The physician had no choice but to pull harder, and when he did the blue delivery catheter separated from the balloon shaft.Now all the remained in the sheath was the actual balloon catheter shaft.The physician then pulled the sheath and the balloon catheter shaft out as one-piece and replaced both with a 18 fr gore tri-seal sheath.There was a severe pressure drop and the team immediately placed an 8 mm balloon into the vessel to stop the bleeding and assess the iliac damage.It was clearly a dissected vessel with extravasation into the retroperitoneum.A 10mm x100 mm viabhan stent was then placed from the distal end of the 12 mm iliac aaa limb, into the external iliac.The pressure did not recover so the team performed cpr.The pressure recovered but there was still some extravasation around the limb in the proximal portion so a second viabhan was placed into the aaa limb, this time a 13 mm x 100 mm.It sealed.The patient recovered well and the pressure stabilized.The patient left the room with no other issues.The case was reviewed after and it was believed that the aaa stent graft limb caused the sheath to kink and that is what caused the issues.The iliac dissection was attributed to the kinked sheath.

Manufacturer Narrative

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.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 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.In this case, per report, it was believed that the aaa stent graft limb caused the sheath to kink, resulting in the subsequent difficulties.There was no allegation of device malfunction.The iliac dissection was attributed to the kinked sheath.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 (b)(4) basis, and any excursions above the control limits are assessed and documented as part of this (b)(4) review.No corrective or preventative actions are required at this time.

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 4266552
• MDR Text Key: 5299848
• Report Number: 2015691-2014-02746
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• 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
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2016
• Device Model Number: 920ES29
• Device Lot Number: 59860467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2014
• 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: 87 YR