MAUDE Adverse Event Report: EDWARDS LIFESCIENCES RETROFLEX DILATOR KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number 9100DKS7US

Device Problem Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 01/16/2014

Event Type  Injury  

Event Description

As reported by the edwards clinical field specialist, at the start of the transfemoral tavr procedure, the 16f, 18f, 20f, 22f, and 23f dilators were advanced in the left common femoral artery without issue.The 25f dilator would not completely advance.It was decided to remove the dilator surgically, and was done so without incident.The case was aborted and the patient was to be brought back for ta access.Per report, the physician was new to the tavr procedure and after resistance was met when inserting the dilator, and after consulting with both the surgeon and another cardiologist, it was decided that the dilator should be removed surgically.This was done to ensure safe removal of the dilator.A larger cut-down was performed to expose the femoral artery.The dilator was manually removed from the common femoral while a clamp was placed proximally to prevent blood flow.The femoral artery was sewn up.The patient¿s access vessel minimum luminal diameter (mld) was measured at 7.0.The vessel was noted to be mildly calcified and moderately tortuous.

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, 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, the patient¿s access vessel minimum luminal diameter (mld) was measured at 7.0mm.The minimum luminal diameter for a 22fr sheath is 7mm.The vessel was noted to be mildly calcified and moderately tortuous.The cause for the difficulty advancing the dilator cannot be confirmed; however, it was reported that the perceived cause was due to tortuosity of the vessel.The borderline mld could also have been a contributing factor.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: RETROFLEX DILATOR KIT
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3621128
• MDR Text Key: 4172604
• Report Number: 2015691-2014-00288
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2014
• Device Model Number: 9100DKS7US
• Device Lot Number: 59384100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Date Device Manufactured: 11/13/2012
• 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: 84
• Patient Weight: 63