MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH PLUS; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/06/2023

Event Type  Injury  

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra valve in aortic position.During the procedure, upon initial sheath insertion, there was notable difficulty advancing the sheath into the femoral artery.The sheath was removed, and the distal tip was noted to be slightly "cracked" and malformed.A new sheath was prepped and inserted without difficulty.Upon removal after the tavr implant, it was noted that the perclose sutures had failed, leading to the need for inserting a new 14fr sheath (non-edwards product) and a vascular surgery consult.The patient was taken to the or for surgical vascular repair.Of note, the implanting physician stated, "i think the first sheath got caught up on the perclose suture, which is why we had trouble inserting it initially.".

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaints for "inability to introduce sheath," "distal tip damage," and "interventional device interacts with non-edwards device" were unable to be confirmed without the return of the device/relevant imagery.As the device was not returned, engineering was unable to perform any visual examination, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.Inability to introduce sheath & distal tip damage: as reported, "upon initial sheath insertion, there was notable difficulty advancing the sheath into the femoral artery.The sheath was removed, and the distal tip was noted to be slightly "cracked" and malformed." per the training manual, "push force can vary due to angle of access and insertion, vessel diameter, tortuosity and degree of calcification." per imagery review, calcification and tortuosity were present in the patient-s right access vessel.Calcification can create a restricted access and obstacles for insertion, which may lead to the reported resistance during the insertion of the sheath.Tortuosity and calcification can subject the sheath to suboptimal angles, which can also contribute to resistance.Sharp nodules of calcification can damage the sheath tip through direct contact during sheath insertion into the vessel.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.Interventional device interacts with non-edwards device: as reported, "it was noted that the implanting physician stated, 'i think the first sheath got caught up on the perclose suture, which is why we had trouble inserting it initially.'" as calcification and tortuosity were present within the access vessels, it is possible that the sheath interfered with the closure device.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.However, a definitive root cause is unable to be determined 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

Event Description

As per follow-up with the fcs, access was achieved via the right femoral and the device was prepped correctly.The angle of insertion was approximately 35 degrees.The dilator was fully inserted and pre-dilation was performed with the included 16fr dilator.There was no difficulty noted inserting the delivery system though the sheath as well as no withdrawal difficulty experienced.

• Brand Name: EDWARDS ESHEATH PLUS
• Type of Device: INTRODUCER, CATHETER
• 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: 17849343
• MDR Text Key: 324658080
• Report Number: 2015691-2023-16462
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)250605(11)2306062165128956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 65128956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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 Sex: Female