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

Model Number	916ESA
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is one of two manufacturer reports being submitted for this case.Investigation is ongoing.
Event or Problem Description
As reported, during a tf tavr case, the team was unable to deliver the first 29mm sapien 3 valve through the first 16f esheath.The team ended up implanting that valve in the descending aorta rather than attempting to remove it through a badly damaged sheath.The team switched access site to the left femoral artery and were successful in implanting a second 29mm sapien 3 valve in the correct aortic position through a second 16f esheath.The right side required a cut-down repair of the femoral artery, but otherwise the patient is stable and recovering.Of note, the physician experienced more than usual resistance while attempting to push the commander with valve through the esheath.It was revealed on fluoroscopy that the crimped valve had started to avulse the esheath.After an aortic occlusion balloon was placed from the contralateral groin, and another physician performed a cut-down on the right femoral artery, unsuccessful attempts were made to retrieve the valve back into the esheath.The decision was made to try and advance the valve forward into the esheath with the occlusion balloon on standby, but this was not successful initially; however, after the amplatz extra-stiff wire was exchanged for a lunderquist, the system advanced back into the sheath and eventually into the aorta.At this point, as lv access had been given up with the wire exchange, the decision was made to implant the first valve in the descending aorta rather that pull the valve, delivery system, sheath combination out as a unit as there was concern of causing damage to the ilio-femoral system.After the second valve was successfully implanted, the team turned their attention to removing the first delivery system and sheath from the right groin, anticipating some damage to the common femoral which in fact did occur.The cfa was repaired through the cut-down exposure they had performed earlier in the procedure.An aortogram/runoff was performed using digital subtraction revealing no damage to the vasculature.Additional information was received, advancement was difficult from the start and it did not get easier even entering into the expandable section.There was a deep diving external iliac artery on the right, with a borderline kink.This is where the sheath avulsed.The damage occurred in the middle section of the sheath.The liner was torn and there was a puncture in the sheath shaft.There was no damage to the first valve or first delivery system.
Additional Manufacturer Narrative
Please reference related manufacturer report no: 2015691-2021-06288.Added h.6 type of investigation and investigation findings.Corrected d.2, g.4, and h.6 investigation conclusions.The device was not returned for evaluation.A dhr 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 and there were no other complaints found.Imagery was provided of the patient's anatomy.Their access vessels had calcification and were tortuous.The ifu, device preparation manual, and procedural training manual were reviewed.During delivery system insertion through the sheath, correctly orient the delivery system and check position before insertion.Orient the delivery system with the flush port pointing away and the edwards logo facing up.Ensure delivery system is locked in default position.Maintain edwards' logo up throughout the procedure to prevent kinking of the delivery system.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 while advancing the thv/delivery system 1-2cm.In expectation of high friction, use short movements.No ifu/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.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.As no edwards defect that could have resulted in the complaint was identified, no preventative or corrective actions are required.The difficulty inserting through the sheath, sheath puncture, and liner torn were unable to be confirmed.Without the return of the complaint device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, no manufacturing non-conformances were able to be identified.However, reviews of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.Per the complaint description, 'the physician experienced more than usual resistance while attempting to push the commander with valve through the sheath'.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in the technical summary.The technical summary provides details of contributing factors for increased resistance during insertion and advancement of the delivery system through the sheath.The following vessel characteristics and procedural factors were identified as the root causes for encountering increased resistance: - tortuous vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Per evaluation of the provided imagery, the patient's access vessel had presence of tortuosity.The complaint description also states a 'deep diving external iliac artery on the right'.- calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Per evaluation of the provided imagery, the patient's access vessel had presence of calcification.- undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Imagery review showed the vessels were sufficiently sized.- steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.The insertion angle was deemed 'appropriate, maybe 30-35 degrees' per the follow-up information.The technical summary also outlines the extensive manufacturing mitigations in-place to detect a defect or nonconformance associated with an esheath resistance with delivery system.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.An existing technical summary has been documented for root cause analysis on sheath shaft liner tears with normal liner expansion.In this technical summary, a review of liner tear complaint investigations on returned devices over a two-year period found that patient / procedural factors (e.G.Access vessel tortuosity / calcification or withdrawal of a burst or torn balloon) are likely the contributing factors for sheath shaft liner tears.Per the complaint description, 'it was revealed on fluoroscopy that the crimped valve had started to avulse the esheath'.Per review of provided imagery, calcification and tortuosity was noted to be present within the patient's access vessel.Tortuous patient anatomy can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.The presence of calcification can directly damage the exposed portion of the sheath liner, which could lead to immediate cutting/tearing or weakening of the liner.A weakened liner can tear during advancement or retrieval of the delivery system.The experienced resistance during delivery system advancement also likely exasperated these factors making it more likely for the delivery system with crimped valve to make contact with the sheath liner with any potential excessive manipulation to overcome the resistance.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and that the mitigations in place during manufacturing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.Available information supports that patient factors (calcification, tortuosity) and/or procedural factors (excessive manipulation, valve caught on liner) may have contributed to the complaint event.Per follow-up information, there was a puncture in the sheath shaft.As resistance was met during system advancement through the sheath, the operator likely manipulated the delivery system to continue advancing the delivery system.It is possible that crimped valve interacted with the sheath, leading to the reported puncture.Vessel tortuosity may have also exasperated this through non-coaxial alignment between the crimped valve and the sheath inner lumen.As such, available information suggests that patient (tortuosity) and/or procedural (excessive manipulation, valve caught on sheath) factors may have contributed to the reported 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: 12807507
• Report Number: 2015691-2021-06286
• Device Sequence Number: 5484733
• Product Code: DYB
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230617(10)63837777
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 12/23/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: 916ESA
• Device Lot Number: 63837777
• Was Device Available for Evaluation?: No
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male