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

Model Number 9610ES14

Device Problem Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2023

Event Type  Death  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by an edwards denmark affiliate, during a left transfemoral tavr procedure with a 26 mm sapien 3 ultra valve, during insertion of the commander delivery system and valve into the 14 fr esheath, resistance was felt.The team attempted to remove the delivery system and advance forward without too much force.However, the esheath seemed began to split while pressing against the calcified femoral artery exposing the valve.The valve went out of the esheath, and got stuck in the calcium located on the groin of the patient.To prevent further damage by pulling out the esheath and device, it was decided to surgically remove the devices.During the cutdown, the esheath and commander delivery system were retracted, but the valve was still in the external iliac artery.The valve was located and removed, but the inside of the artery was severely damaged, and an iliac-femoral bypass was performed.The external and internal iliac was sutured, and the prosthesis was tunneled under the ligament to the groin, and the patient was doing well.Per medical records review, on post operative day 3, the patient experienced shortness of breath, and the patient went into a-fib, then into ventricular tachycardia, and then asystole.The patient's status was do not resuscitate (dnr), therefore, there were no actions taken to revive the patient.The cause of death was noted to most likely be a pulmonic embolism after extensive surgery, due to lying flat in the bed and not being given anticoagulants post procedure.Per report, the event was not due to any device failure, but due to patient's anatomy and level of calcification.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation.The esheath was visually inspected upon return, and the following was observed: liner torn from distal tip to strain relief; delivery system puncturing through torn liner.Kink in sheath shaft at 8.5cm from strain relief, the distal tip opened as designed, and the esheath shaft had scratches and damage.Dimensional testing was performed, and the liner thickness was measured along the liner tear.All measurements met specification.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 complaints for difficulty advancing through esheath and liner punctured were confirmed through evaluation of the returned device.An existing technical summary written by edwards lifesciences captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.Product risk assessment is also captured in the technical summary which documents the difficulty advancing the delivery system through the sheath, resulting in system components interfere with access vasculature resulting in additional surgical intervention.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 per the complaint description and follow up communication, there was tortuous anatomy, and it was discussed as an issue.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 per the complaint description, the access vessel was 'very calcified almost circular at some points'.In addition, per visual inspection of returned device, scratches were observed on the sheath shaft.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 or liner 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 procedural factors (excessive manipulation, valve caught on sheath) may have contributed to the reported event.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 corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER
• 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: 16651049
• MDR Text Key: 312398505
• Report Number: 2015691-2023-11983
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Lot Number: 64423132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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): Death
• Patient Age: 87 YR
• Patient Sex: Male