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

Model Number 914ESA

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 08/09/2023

Event Type  Injury  

Event Description

As reported from pro clinical study, a 14f esheath was prepped.Along with the sheath, a 23mm s3 ultra valve, and 23mm commander delivery system (ds) were all prepped without incident.The esheath was inserted into the right common femoral artery (rcfa) without incident.Upon entry of the 23mm delivery system, the operator had difficulty pushing the ds through the sheath.The ds and valve were stuck approximately halfway through the sheath.The operator tried a couple of times to continue advancing but the push forces were too great.The operator injected a small amount of propofol to lubricate the internal dimensions of the sheath but this also didn't resolve the issue.The decision was made to remove the sheath, ds and valve and prep a new system.A newer esheath plus, new 23mm s3 ultra and 23mm ds were again prepped without incident and the case went smoothly.Upon removal of the second sheath a small focal dissection was noted in the rcfa by one of the supporting physicians.The physician felt it was insignificant and that the team should check on leg blood flow with echo later in the day.Additional information received noted that the patient reported to hospital with right leg issues (leg pain and discoloration of the toes) following the procedure.At this point it is unknown if issue was the result of the sheath or the closure device.

Manufacturer Narrative

Investigation is ongoing.H3 other text: not returned.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.Investigation is ongoing.

Event Description

As reported from pro clinical study, a 14f esheath was prepped.Along with the sheath, a 23mm s3 ultra valve, and 23mm commander delivery system (ds) were all prepped without incident.The esheath was inserted into the right common femoral artery (rcfa) without incident.Upon entry of the 23mm delivery system, the operator had difficulty pushing the ds through the sheath.The ds and valve were stuck approximately halfway through the sheath.The operator tried a couple of times to continue advancing but the push forces were too great.The operator injected a small amount of propofol to lubricate the internal dimensions of the sheath but this also didn't resolve the issue.The decision was made to remove the sheath, ds and valve and prep a new system.A newer esheath plus, new 23mm s3 ultra and 23mm ds were again prepped without incident and the case went smoothly.Upon removal of the second sheath a small focal dissection was noted in the rcfa by one of the supporting physicians.The physician felt it was insignificant and that the team should check on leg blood flow with echo later in the day.Additional information received noted that the patient reported to hospital with right leg issues (leg pain and discoloration of the toes) following the procedure.At this point it is unknown if issue was the result of the sheath or the closure device.More clarifying information received noted that it's difficult to determine when the dissection occurred.There was no damage to the first sheath and the second sheath was not looked at.There was no difficulty in placing either sheath.The patient did have small peripheral vasculature, but there were no difficulties.If the field clinical specialist were to guess, he thinks maybe the first sheath caused the focal dissection because that is where the doctor and his team were struggling to get passage of the delivery system.The issue may have been caused by the closure device following the removal of the sheath but is not known for sure.

Manufacturer Narrative

Updated section h6.The returned device was examined, and the following visual observations were noted: the sheath shaft is kinked is 2.75" from comnut.The strain relief is torn approximately 3" from distal strain relief.Scratches are present on the sheath shaft.The associated delivery system was advanced through the sheath, and the tip opened, and liner expanded as designed.Procedural imagery was reviewed, and the following observations was made: tortuosity is present within patient's access vessels (right access).Vessel sizes were analyzed by both the site and by edwards personnel prior to the procedure.Vessel sizes appeared undersized when performed by the site while edwards personnel deemed the vessel sizes were appropriate for use with edwards esheaths.Undersized vessels were excluded as a potential root cause based on edwards personnel analysis.The complaint for resistance between system components causing inability to advance through the sheath was confirmed.Available information suggests tortuosity likely contributed to the event.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen resulting in difficulties advancing.As the returned sheath was kinked, it is possible this damage was a result of the high push force attempted to overcome the resistance.It is possible this kinked region interacted with the patient anatomy contributing to the vessel dissection; however, this interaction was unable to be confirmed through this investigation.Per the instructions for use (ifu), cardiovascular injur ies such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by ew, vascular complications are a well-recognized complication of the transfemoral thv 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.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.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 this adverse event is not required at this time.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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.A product risk assessment has been previously initiated to capture the risk associated with difficulty advancing the delivery system through the sheath, resulting in system components interfering with access vasculature, damaging tissue resulting, and additional percutaneous intervention.

• Brand Name: EDWARDS ESHEATH INTRODUCER SHEATH
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 17649504
• MDR Text Key: 322256342
• Report Number: 2015691-2023-15569
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)230819(10)63946944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 914ESA
• Device Lot Number: 63946944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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; Hospitalization