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

Model Number 9610ES14

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Injury  

Event Description

As reported from our affiliates in italy, this was a case with a 26mm sapien 3 ultra transcatheter valve in aortic position by transfemoral approach.During the procedure, the valve got stuck in the esheath as it was attempted to advance with the valve without success.It was decided to remove the valve and esheath as the team noticed that the esheath was damaged (lacerated about 4cm) at the fully expandable portion due to severe tortuosity and calcification of the vessel.The valve was not damaged.Femoral and common iliac arteries were isolated surgically to remove the devices stuck in the femoral.A common femoral artery section was replaced by a dacron prosthesis.The following day, the patient received a 26mm sapien 3 ultra valve.Patient outcome was good.The patient remained hospitalized.

Manufacturer Narrative

Investigation is ongoing.

Manufacturer Narrative

Updated h6-type of investigation, investigation findings, investigation conclusions.The device was not returned for evaluation.The complaints for inability to advance through sheath and sheath damage were unable to be confirmed due to no imagery/device provided.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in the technical summary were reviewed and the following were identified as applicable to this 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.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.As reported, the patient's vessel had "severe tortuosity." -calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.As reported, the patient's vessel had "severe calcification.".The presence of the above factors can create challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Excessive device manipulation applied to overcome the resistance can further damage the sheath through continued interaction between the crimped valve and sheath.Vessel calcification and/or tortuosity can exasperate the interaction between the crimped valve and sheath.Sharp calcified nodules can directly weaken the sheath shaft making it more susceptible to damage as the delivery system with crimped valve is advanced through.Tortuosity can subject the sheath to suboptimal angles that can lead to shaft kinks.Excessive manipulation can lead to sheath shaft damage (i.E.Kinks, scratches, tip damage) if compounded with vessel calcification and/or tortuosity.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with this issue.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.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.As such, available information suggests that patient factors (calcification, tortuosity) and/or procedural factors (excessive manipulation, valve caught on sheath) may have contributed to the events.The complaint for difficulty removing sheath was unable to be confirmed due to no imagery/device provided.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, "femoral and common iliac arteries were isolated surgically to remove the devices stuck in the femoral." it was reported that the patient's vessels had "severe tortuosity and calcification." calcification can reduce the vessel diameter and may increase restriction leading to withdrawal difficulty.Additionally, calcified nodules can catch onto the sheath shaft and increase friction during withdrawal.Tortuosity can subject the sheath to suboptimal angles which can also increase friction and further contributed to the reported withdrawal difficulty.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the difficulty removing sheath.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure modes are not required 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.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 resulting in additional surgical intervention.A corrective/preventative action was previously initiated to pursue potential process improvement activities regarding this event.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16562301
• MDR Text Key: 311479196
• Report Number: 2015691-2023-11535
• Device Sequence Number: 1
• Product Code: DYB
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 64556269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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 Age: 89 YR
• Patient Sex: Male