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

Model Number 916ESJ

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Intimal Dissection (1333); Occlusion (1984)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As reported by our (b)(4) affiliate, during a transfemoral tavr, upon removal of the 16 fr esheath it was observed that the patient had a femoral artery occlusion and an iliac artery dissection.The area was surgically repaired.The patient¿s access vessel minimum luminal diameter was 6.0 mm with mild calcification and severe tortuosity.A ¿strong resistance¿ was encountered while advancing the delivery system in the esheath.The procedure was proceeded as usual and a 29mm sapien 3 valve was deployed in an intended position.After retrieval of the esheath, digital subtraction angiography showed blood flow into the superficial femoral artery, but not into the deep femoral artery.It was revealed that an external iliac artery dissection had occurred and the ¿detached intima¿ flowed into the femoral artery, which cause the occlusion.The vessel was surgically repaired and the detached intima was removed.Blood flow to the vessel was confirmed and the treatment was completed.

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.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.The device and relevant photographs, videos and imagery were not provided to edwards lifesciences for evaluation.Due to the unavailability of the relevant device, engineering was unable to perform any visual, functional or dimensional analysis.As a result, a manufacturing non- conformance was not identified.A review of the manufacturing processes supported that the sheath and delivery system have proper inspections in place to detect issues related to the reported event.Based on the applicable device history record (dhr) review, lot history review, and complaint history review, there is no evidence to confirm a manufacturing non- conformance contributed to the reported sheath resistance with delivery system.Per training materials, the push force can vary due to angle of insertion, vessel diameter, tortuosity, and degree of calcification of the patient.These factors can restrict the ability of the esheath to expand and may create a difficult pathway to advance the delivery system through the sheath.The minimum required vessel diameter (mld) for a 16 fr sheath is 6.0 mm.The patient¿s access vessel mld was reported to measure 6.0 mm with mild calcification and severe tortuosity.In this case, it appears that patient factors (mld near the minimum required diameter, severe tortuosity) likely contributed to the iliac artery dissection.The femoral artery occlusion may have been related to the detached intima.The complaint of ¿sheath shaft resistance with delivery system¿ was unable to be confirmed due to the unavailability of the relevant device (and/or imagery, videos or photographs).Therefore, it cannot be determined if a manufacturing non-conformance contributed to the complaint.As such, available information suggests that patient factors (calcification and tortuosity) may have contributed this event.However, a definite root cause is unable to be determined.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.

• 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: 6989512
• MDR Text Key: 90626800
• Report Number: 2015691-2017-03640
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140031
• 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: 10/06/2017

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: 06/12/2019
• Device Model Number: 916ESJ
• Device Lot Number: 60946412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2017
• 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: 83 YR
• Patient Weight: 40