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

Model Number 914ESA

Device Problems Mechanical Problem (1384); Peeled/Delaminated (1454); Material Rupture (1546); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.This is one of three manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2021-03687 and 2015691-2021-03688.

Event Description

Edwards received notification from a field clinical specialist that during a tavr via the right subclavian approach, there was resistance between the 23 mm sapien 3 ultra valve with commander delivery system and the esheath.The valve on the delivery system had ruptured the esheath and punched through the right subclavian artery in the expandable portion.As reported, while attempting to place the 23 mm valve, the system seemed to be stuck in the esheath.The valve on the delivery system had ruptured the esheath and punched through the right subclavian artery in the expandable portion.The right subclavian before the carotid artery tore away.The system could not be withdrawn from the artery.A vascular surgeon was called in and the cut down was enlarged.Upon withdrawal, the valve was flared.It was not round but oval.Tissue was found on the valve.The patient coded and cpr was performed.Several units of blood were given.It appeared the right side chest was engorged with blood and the patient passed.The delivery system was removed and washed.The image of the used devices showed sheath liner torn, sheath shaft kink, and what appeared to be bent struts at the outflow.The balloon on the delivery system appeared to show the nose tip was separated.Per pre-deco findings, there was a liner strand on the esheath and the delivery system balloon was separated at the wings.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected, and the following was observed: the sheath liner was torn with the valve exposed through it.The liner tear started 1.6 inches from the distal end of strain relief with a length of approximately 8.5 inches two (2) liner strands were observed.The first liner strand was starting 4 inches from the strain relief (2.5 inches in length).The second liner strand was starting 5 inches from the distal tip (approximately 1.75 inches in length).Tip opened and sheath liner expanded as designed.Two (2) kinks on sheath shaft.The first kink was approximately 3 inches from distal tip, and the second kink was 4 inches from strain relief.Multiple scratches observed along sheath shaft, and deep scratches near distal tip.Since the returned sheath was fully expanded, and sheath tip was opened, so no applicable functional testing was performed.Liner thickness were measured along the liner tear and strand as an out of specification result could be indicative of a manufacturing non-conformance.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.3mensio and device imagery was provided by the site was reviewed and the following was observed: patient access vessel on the right side was tortuous and calcified.Post procedure of sheath bent along with liner tear and exposing the delivery system (with valve).Procedural imagery of vascular damage near valve.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.The complaints of inability to advance valve and delivery system through sheath, sheath liner torn, sheath kinked, bent, and sheath liner strand were confirmed through evaluation of the returned device.However, no manufacturing nonconformances were identified during the evaluation.Reviews of the complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device preparation.For the complaint of inability to advance valve and delivery system through sheath.As reported, 'while attempting to place the 23mm valve, the system seemed to be stuck in the sheath.The team looked for a kink but none observed'.Per 3mensio imagery, the patients access's vessel had presence of calcification and tortuosity.Additionally, evaluation of the returned device revealed the presence of shaft scratches and a shaft kink, which can be indicative of contact with vessel calcification.The procedural training manual states, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' access vessel characteristics such as calcification can create a challenging pathway for delivery system insertion/advancement through the sheath.Calcification can reduce the vessel diameter preventing sheath from proper expansion which may lead to resistance.The presence of tortuosity in the access vessels, as seen in provided 3mensio, can create a challenging pathway for the delivery system and prevent the sheath from fully expanding, increasing the necessary push force to advance the delivery system through the sheath.A product risk assessment was previously performed per management discretion to assess the risks associated with high push force of the sapien 3 ultra valve with the commander delivery system and esheath configuration.In addition, a capa was previously initiated to capture further investigation and any possible corrective or preventative action activities.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the reported event.For the complaint of sheath kink, as resistance during delivery system insertion was experienced, it is possible that the devices were excessively manipulated to overcome any difficulty due to tortuous and calcified anatomy.This may have led to the crimped valve to interact with the sheath, leading to the observed sheath kink, liner tear and strands.Per training manual, 'do not over-manipulate the sheath at any time'.Additionally, the presence of sharp calcified nodules can also weaken the liner material making it more susceptible to tearing, especially when compounded with excessive device manipulation.As such, available information suggests that patient (calcification and tortuosity) and/or procedural (excessive manipulation, valve caught on liner) factors may have contributed to the reported events.No labeling/ifu deficiencies were identified.Therefore, no corrective and preventative action is required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12292058
• MDR Text Key: 267248996
• Report Number: 2015691-2021-04559
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESA
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1