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

Model Number	914ESA
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of three manufacturer reports being submitted for this case.Investigation is ongoing.
Event or Problem Description
As reported, during a tf tavr case in a patient with a history of an evar with a descending aortic stent into bilateral iliac stents, the team placed a lunderquist wire in order to straighten the patient's left iliac artery tortuosity and used a 14f esheath dilator to dilate the vessel.Once the vessel was dilated the esheath was inserted over the wire.The team then replaced the wire with a safari extra stiff wire into the esheath.Next, the team performed a balloon valvuloplasty and the bav balloon was exchanged for the delivery system.As the delivery system with valve traversed the left iliac the team was not able to advance it past the external iliac due to tortuosity.The team attempted to retract the delivery system a little to then readvance at a different angle.This back and forth was performed several times but the delivery system would not advance.The team tried one more time to advance and during this attempt, a strut of the 26mm sapien 3 ultra valve on the inflow side bent backwards at a 90 degree angle.The team discussed the fact that they would need to bring the sheath and delivery system out together and possibly do a groin cutdown.A second esheath was opened and prepped as the team worked with the system stuck in the sheath.The team attempted to bring the sheath and the system out together percutaneously and the patient's blood pressure dropped immediately.Vascular surgery and interventional radiology were called to the room.The tavr team inserted a peripheral balloon from the left wrist in an attempt to tamponade the iliac from above but that was unsuccessful.The patient decompensated, cpr was started, the cardiac surgeon performed a left sided thoracotomy to access the aorta, clamped it, and the left groin was opened in order to control the left iliac, which was torn.The valve and delivery system never exited the sheath.The sheath seem was torn.The devices were surgically removed by the vascular surgeon.The patient was transferred to the va hospital and is doing well, per physicians involved in the case.During pre-decontamination of the returned sheath, the liner tear was confirmed.Additionally, liner strands 1/4 inch in length and 6 inches from the distal tip were observed.
Additional Manufacturer Narrative
Please reference related manufacturer report nos: 20156910-2021-06755 and 2015691-2021-07085.
Additional Manufacturer Narrative
Added h.6 type of investigation and investigation findings.Corrected h.6 investigation conclusions.The device was returned for evaluation.During visual inspection a kink was seen on the sheath shaft approximately 8 inches from the comnut.The valve with bent strut could be seen sticking out of the torn liner.The sheath shaft was fully expanded as designed.The liner tear extends to the distal tip.The tip did not open as designed.A radial split tip was observed.Hdpe damage was seen on the sheath shaft.Liner strands were noted.A liner tear began at 8.25 inches from the comnut and is 2.25 inches long.Due to the nature of the returned device, functional testing was unable to be performed.Liner thickness was measured along the liner as an out of specification result could be indicative of a manufacturing non-conformance.Liner strand measurements were measured along the strands as an out of specification result could be indicative of a manufacturing non-conformance.All measurements met specification.A device history review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed.One other complaint was found.In that case, the presence of manufacturing non-conformances was not able to be determined.Due to insufficient information provided, a definitive root cause was unable to be determined at this time.No labeling or ifu deficiencies were identified.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.Imagery was provided and tortuosity was seen in the patient's access vessels.The ifu/training mitigations/controls relevant to the reported issue are captured in a product risk assessment (pra).Edwards has provided guidelines and instructions to physicians on how to properly handle, prepare, and use the thv and system in the ifu and training materials.The users are instructed on how to screen patients to ensure adequate vessel access and to reduce vascular complications.In addition, a step-by-step instruction on how to insert and advance a delivery system through the sheath including mitigation steps and best practices to address high push force are provided.The users are instructed to correctly orient and lock the delivery system in default position before insertion and for the loader to be fully advanced into the sheath.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, and in expectation of high friction, use short movements and push delivery system closer to sheath hub.Push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification.If push force is high, consider slightly pulling back the sheath 1-2 cm while advancing the thv/delivery system.If push force is too high or valve and sheath are damaged or valve is still stuck, remove valve and sheath together as a single unit and replace, and do not over-manipulate the sheath at any time.In case of vascular injury, vascular complication management instructions are included for resolution.Based on the review, no ifu or training deficiencies were identified.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 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.A product risk assessment (pra) was previously initiated to investigate the cause and assess the risks associated with high push force of the commander delivery system with s3u through the esheath.To address the issue, a corrective action preventive action (capa) was initiated to drive corrective/preventive actions.The corrective action is intended to reduce, but not eliminate the complaint occurrence, and the capa has been closed after demonstrating reduction of complaint rate for frame damaged.The risks outlined in the pra remain the same.The pra documents the difficulty advancing the delivery system through the sheath, resulting in system components interfere with access vasculature resulting in additional surgical intervention, which did occur during this event.No further action is required.Since no product non-conformance was confirmed, a product risk assessment escalation is not required.The inability to advance the devices through the sheath, sheath liner tear, and sheath liner strand were confirmed through evaluation of the returned device.However, no manufacturing nonconformances were identified during the evaluation.Reviews of the dhr, lot history, and 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 the 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.Per the details, 'as our delivery system traversed through the left iliac the team was not able to advance it past the external iliac due to tortuosity.The team attempted to retract the delivery system a little to then readvance at a different angle.This back and forth was performed several times but the delivery system would not advance.The team tried one more time to advance and during this attempt, a strut of the 26mm s3u valve on the inflow side bent backwards at a 90 degree angle.' tortuous patient anatomy can create sub-optimal angles that can lead to nonaxial alignment in the advancement of the delivery a nonaxial alignment can cause difficulty in advancement as well as potentially damaging the thv.Damage to the thv likely caused a strut to 'bend backwards at a 90 degree angle'.This bent strut then likely caught on the liner and further increased resistance to advancing the delivery system.Additionally, per the pra, exposed apices of the crimped s3u thv may increase the rate of the thv getting caught on the sheath, hindering further advancement.The capa has identified potential areas for s3u design/process improvement to mitigate against the failure.As such, available information suggests that patient factors (tortuosity) may have contributed to the complaint event.A nonaxial alignment can cause difficulty in advancement as well as potentially damaging the thv.Damage to the thv likely caused a strut to 'bend backwards at a 90 degree angle'.This bent strut then likely caught on the liner and further increased resistance to advancing the delivery system.To overcome this resistance, excessive manipulation was likely used.This excessive manipulation likely caused the strut to catch onto the liner causing the liner tears and strands.As such, available information suggests that patient factors (tortuosity) and procedural factors (bent valve strut, excessive manipulation) may have contributed to the complaint event.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Common Device Name: 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: 13091091
• Report Number: 2015691-2021-07084
• Device Sequence Number: 19847393
• Product Code: DYB
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)230810(10)63935312
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K200258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: 914ESA
• Device Lot Number: 63935312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 02/18/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 12/27/2021; 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male