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 Injury (2348)

Event Date 05/23/2016

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 xt 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 6.0 mm.The patient¿s access vessel mld was reported to measure 6.3 mm with moderate calcification and mild tortuosity.In this case, the cause of the transfemoral access vessel intima avulsion and the resistance felt upon device withdrawal cannot be confirmed.It is possible that patient factors (borderline access vessel diameter for a 16fr esheath) in combination with 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 our (b)(4) affiliate, at the end of a transfemoral tavr procedure, an access vessel intimal avulsion was observed upon removal of the 16fr esheath and the area was surgically repaired.The tavr procedure was performed via a cutdown obtained on the left femoral artery.Considering the diameter of the access vessel, a non-edwards¿ 24 fr dilator was used in addition to 18-22 fr dilators.No abnormal resistance was noted upon sheath and delivery system insertion.Upon delivery system withdrawal through sheath, abnormal resistance was felt.Following sheath withdrawal, a vascular intimal avulsion was observed in the access vessel.The injury was surgically repaired.The patient was stable at the end of the procedure.The minimal luminal diameter (mld) of access vessel measured 6.3 mm with moderate calcification and mild tortuosity.

Manufacturer Narrative

This is one of two reports submitted for this case.Please reference the related manufacturer report number 2015691-2016-01974.

• 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: 5734849
• MDR Text Key: 47698056
• Report Number: 2015691-2016-01975
• 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: 05/23/2016

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: 11/16/2017
• Device Model Number: 916ES23J
• Device Lot Number: 60238237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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: 89 YR
• Patient Weight: 39