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

Model Number 916ES23J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Intimal Dissection (1333)

Event Date 01/21/2016

Event Type  Injury  

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, 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 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.The minimum required vessel diameter for a 16fr esheath is 6.0mm.In this case, the cause of the reported access vessel dissection cannot be determined.Per report, the patient access vessel mld measured 6.5mm with no calcification and tortuosity.It is possible that there may have been some vessel calcification and/or tortuosity not appreciable on imaging that could have contributed to the event.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

As reported by (b)(4), at the end of a transfemoral tavr procedure, an access vessel dissection was repaired with a stent.The access vessel minimum luminal diameter (mld) measured 6.5 mm with no calcification or tortuosity.No resistance was encountered upon insertion of the 16fr esheath, but resistance was noted upon insertion of the novaflex+ delivery system.Following implantation of a 23 mm sapien xt valve, the esheath was withdrawn and angiography showed a vascular dissection extending from the common femoral artery of the access site to the common iliac artery.A 10 mm x 10 cm stent was placed in the injured site and a 10 mm x 4 cm stent was placed in the access site.The physician was satisfied with the results and the procedure was completed.The proctor stated that the event was unexpected because the nature of the artery looked very good.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation, for this reason a limited investigation was performed.Due to the device and/or applicable photographs (relevant to the reported event) not being returned for evaluation, the reported sheath resistance with delivery system was unable to be confirmed.Due to the unavailability of the relevant device, engineering was unable to perform any visual, functional or dimensional analysis, therefore a manufacturing non-conformance was unable to be determined.The device history record (dhr), complaint history and manufacturing process reviews did not indicate that a manufacturing non-conformance is the likely cause of the customer report.During delivery system insertion through the esheath, insertion forces can vary due to several patient/procedural related factors such as angle of insertion, vessel diameter, tortuosity and degree of calcification.Furthermore, other procedural factors such as incomplete/misaligned valve crimping or incomplete advancement of the loader can also result in delivery system insertion difficulties.It is possible that the aforementioned procedural factors may have contributed to the reported insertion difficulties.Based on the available information the true root cause of the reported resistance could not be determined.No labeling or ifu/training inadequacies have been identified and review of the complaint history for the month of january 2016 revealed that occurrence rate did not exceed the control limits for this failure mode.Therefore, no corrective or preventive 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; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5436779
• MDR Text Key: 38208379
• Report Number: 2015691-2016-00443
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2016

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 Expiration Date: 08/09/2017
• Device Model Number: 916ES23J
• Device Lot Number: 60139736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2015
• 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: 85 YR
• Patient Weight: 42