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

Model Number 916ESA

Device Problem Peeled/Delaminated (1454)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported, during a tf tavr case the patient's abdominal aorta was tortuous and during the removal of commander balloon through the esheath in this tortuousity caused the seam of the esheath to invaginate and kink.The dilator was used to straighten the esheath for removal of the esheath.When the esheath was removed there was a linear vascular tear at the arteriotomy.The vessel tissue at the arteriotomy as stated by the vascular surgeon was anuerysmal and fragile.A vascular surgeon repaired the arteriotomy via surgical cutdown.Imagery provided shows circumferential liner delamination.There was no damage noted to the delivery system.Per the specialist, the blue portion of the esheath had no damage, the clear portion of the esheath delaminated and was pulled into the esheath.

Manufacturer Narrative

The 16f esheath was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A photo was provided and revealed the liner delaminated from the distal end of the sheath.A 3mensio revealed the patient vessel condition as tortuous aorta and tortuous access vessels.During the manufacturing process, visual inspections and tests are performed throughout the process.During esheath assembly and sheath shaft component of the sheath is visually inspected for defects.During final assembly, the esheath is 100% visually and dimensionally inspected by both manufacturing and quality for defects.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history record review was performed and did not reveal any related complaints.The esheath ifu, commander delivery system s3 ifu, device preparation manual, and procedural training manual were reviewed for guidance and instructions.The procedural manual provides guidance on delivery system removal.Completely unflex the delivery system, ensure flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath and maintain guidewire position in the aorta.Note that patient injury could occur if the delivery system is not completely unflexed prior to removal.In addition, the procedural training manual provides guidance on sheath removal.Remove the suture securing the sheath, remove the sheath entirely without torquing ensuring the edwards logo is facing upwards, do not re-advance the sheath at any time during removal, and hemostasis will not be maintained if the sheath is partially removed past the partially expandable section.Reinsert dilator into the sheath or have an appropriate dilator ready to occlude the vessel if required.Appearance of the sheath upon removal some curvature of the sheath may be present, ripples along the seam are normal and an open tip and seam are to be expected.It is important to remember through the procedure to: initially insert the introducer sheath with the edwards logo facing up, suture the sheath in place, once completed, remove the sheath completely with the edwards logo facing up, remove the sheath without torquing, and do not re-advance or reinsert the sheath at any time.There were no ifu/training deficiencies identified.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 complaint for sheath liner delamination was confirmed through the provided imagery.However, as the device was not returned, engineering was unable to perform any visual, functional, or dimensional testing.Therefore, a manufacturing non-conformance was unable to be confirmed.However, review of dhr, lot history, and complaint history showed no indication a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.Additionally, there was no report of any issues with the sheath during device preparation or unpacking, indicating that this was not an out of the box issue.As reported, 'the patient's abdominal aorta was tortuous and during the removal of commander balloon through the esheath in this tortuosity caused the seam of the esheath to invaginate and kink.The dilator was used to straighten the esheath for removal of the esheath.' as the patient's aorta and access vessels were tortuosity, there likely was non-coaxial alignment between the delivery system and the sheath distal tip, leading to the delivery system to get caught on the sheath liner.As it was caught on the liner, excessive manipulation may have been applied to overcome the difficulty experienced, which would have further delaminated the sheath liner.In this case, available information suggests that procedural factors (excessive manipulation, non-coaxial alignment) and patient factors (tortuosity) may have contributed to the complaint events.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no product risk assessment no corrective or preventative action is required at this time.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irv CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 12872688
• MDR Text Key: 282188872
• Report Number: 2015691-2021-06532
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230318(10)63694685
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: 916ESA
• Device Lot Number: 63694685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male