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

Model Number 9610ES14

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.The investigation is in progress, a supplemental report will be submitted.

Event Description

Edwards received notification from our affiliate in italy.As reported, this was a case of an implant of a 26mm sapien 3 ultra valve in the aortic position by transfemoral approach.The patient presented with iliac calcifications all along the vessel which were studied at the screening.During the procedure, resistance was found while advancing the valve through the esheath, the valve got stuck in the esheath introducer.When checking the devices, it was noticed that the valve frame was bent at the skirt level.The esheath was removed together with the commander delivery system and valve inside.No cutdown was needed.After withdrawal, it was found that the esheath was torn.A new kit was prepared to continue with the procedure.The valve was successfully deployed, with good result and the patient was in good condition.No vascular damage was found performing the iliac and femoral angiography.As per the evaluation of the device photos provided, it was found that the esheath shaft was damaged and there was a liner strand.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.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 of resistance between system components, sheath liner torn, sheath liner strand, and sheath damaged were confirmed through review of provided imagery.An existing edwards' 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 technical summary.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.Per review of provided imagery, tortuosity was present in the access vessels.In addition, the sheath shaft presented curvature.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.Per complaint event, ''iliac calcifications all along the vessel''.In addition, per review of the provided imagery, calcification was present in the access vessels.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion and increased resistance during the advancement of the delivery system.Per review of provided imagery, the access vessels were undersized (less than 6.0mm, which is the minimum required vessel diameter for use with the 16f esheath).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 liner and/or hdpe 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 further shaft damage.Excessive manipulation can lead to sheath shaft 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 (undersized vessel, tortuosity, calcification) and procedural factors (valve c aught on liner, valve caught on sheath, excessive manipulation) may have contributed to the reported event.Since no edwards defect was identified, no corrective or preventative action is required.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.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-12335.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• 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: 16747090
• MDR Text Key: 313398107
• Report Number: 2015691-2023-12334
• 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: 05/18/2023

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
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 64642745
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1