MAUDE Adverse Event Report: EDWARDS LIFESCIENCES NOVAFLEX+ DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9355FS23

Device Problems Burst Container or Vessel (1074); Fracture (1260); Leak/Splash (1354); Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

Udi (b)(4).The device was not returned to edwards lifesciences for evaluation, as it was discarded at the facility. per the instructions for use (ifu), mechanical failure of delivery system, and/or accessories is a potential risk of the tavr procedure.According to the ifu cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral tavr procedure.Transcatheter delivery balloon burst complaints have been previously investigated by edwards lifesciences and documented in technical summary.A detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the native aortic valve when the inflated delivery system balloon comes in contact with the native annular calcification at full inflation/deployment.In addition, the balloon burst increases the possibility of an obstacle (i.E.Patient's anatomy or sheath tip) interfering with retraction of the balloon/balloon material.The physician training manual provides the following instruction: if the inflation balloon leaks or bursts, do not use excessive force when removing the balloon.In this case, per report patient factors (sharp piece of calcium) likely caused the balloon burst, which may have in turn caused the withdrawal difficulty damaging the sheath and resulting in artery trauma.   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 affiliates in (b)(6), during the post dilation of the 23mm sapien xt valve due to perivalvular leak (pvl), by left side tf approach in aortic position, the balloon burst on a sharp piece of calcium.It was not possible to retrieve the balloon back into the e-sheath causing severe damage to the e-sheath and subsequently an artery trauma.However, it was managed to get the delivery system and sheath out of the patient through the access site.Afterwards the vascular surgeon surgically repaired the vessel.Despite the complications, the pvl was reduced to mild and the patient was stable post procedure.The access vessel minimum luminal diameter measured 6.0 mm with moderate calcification and tortuosity.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: NOVAFLEX+ DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7890703
• MDR Text Key: 120978658
• Report Number: 2015691-2018-03852
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2019
• Device Model Number: 9355FS23
• Device Catalogue Number: 9355FS23A
• Device Lot Number: 61093020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR