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

Model Number 916ESPA

Device Problems Peeled/Delaminated (1454); Material Integrity Problem (2978)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure a 29mm sapien 3 ultra resilia valve was implanted in a heavily calcified aortic annulus and the commander delivery system ruptured during deployment.Post deployment, a second 29mm commander delivery system was used to expand the valve with post dilation.The balloon was able to fully expand the 29mm valve, but the delivery system balloon also ruptured (appeared to be because of heavy calcium).The balloon was brought into the 16 fr esheath+ but with greater push force than a normal removal.They advanced the balloon slightly and then again tried to remove the balloon through the esheath+.As the team watched the balloon enter the esheath+, the radiopaque ring at the tip of the esheath+ appeared to move and there was concerned with dislodgement.As most of the balloon was inside of the esheath+, it was decided to bring the balloon/delivery system/esheath+ out of the body all together as one unit.Upon inspection of the esheath+ after removal, the inner lumen appeared to have in-fold into the esheath+ with the radiopaque ring still attached to the liner.At the end of the procedure, the patient was doing well no issues with the valve or vasculature.

Manufacturer Narrative

Investigation is ongoing.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2024-00879.H3 other text : device pending return.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering pre-decontamination evaluation findings, sections g6, h2, h6: additional device code added.Investigation is still ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, have been updated.Additional codes have been added to h6 type of investigation.Codes were corrected in h.6 component code: investigation findings and investigation conclusions based on investigation completion.The events reported are anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.The returned device was visually examined for any abnormalities and the following was observed: the 16fr esheath plus returned separately.The c-marker band is missing from sheath distal tip.The liner is very bunched at distal end and the tip is opened as designed.The sheath shaft damage, hdpe stretching and damage at 9.25cm from shaft tip.Engineering stretched out bunched liner and upon stretching out the liner, the c-marker band was absent.This observation indicates that an incomplete device was returned since the c-marker was present at the end of procedure, as reported.Engineering looked for detached marker band but unable to locate or identify c-marker band.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The esheath/esheath+ is designed in a way that expansion of the sheath allows for retrieval of the system with minimal damaging interactions to the integrity of the balloon or the nosecone of the system.Commander delivery system retrieval through the esheath/esheath+ is validated.To promote maintaining sheath integrity, design requirements and drawings include sheath tip and shaft materials selection and dimensions.Mitigations include visual and dimensional inspections of the sheath components and assembly.Users are informed of the residual risks associated with the valve, delivery system and/or accessories through the potential adverse events section in the instructions for use (ifu).To help mitigate risks, edwards provides guidance and instructions on visualizing and assessing vasculature, correct device prep, and proper insertion techniques in the ifu and training/refresher training materials, including adequate hydration of components, appropriate orientation of the esheath/esheath+ seam in the vasculature, and the risk associated with excessive calcification or tortuosity.Edwards also provides how to retrieve the delivery system (with or without the crimped valve), including if the delivery system balloon is ruptured.In addition, edwards physician training program includes case observation/review, proctor qualification and refresher training.Review of prior closed similar complaints that were able to be confirmed indicates that patient and/or procedural factors can contribute to circumferential liner delamination of the sheath which can manifest during withdrawal of the delivery system.Furthermore, the review did not identify an edwards related defect that may have contributed to any of the complaints.Procedural factors such as withdrawal of a delivery system with an altered balloon profile (burst/torn balloon, residual fluid in balloon, etc.) can lead to the system to catch onto the sheath liner.In addition, non-coaxial alignment between the devices can also lead to delivery system to catch onto the sheath liner, especially if patient factors such as calcification, tortuosity, and/or undersized diameters near the sheath distal tip are present within the patient anatomy.As a result, the operator may apply excessive manipulation to overcome any difficulty, which can further delaminate the liner as the delivery system is pulled through the sheath.Furthermore, more than one of these factors can compound to exacerbate the patient/procedural conditions and further lead to sheath liner delamination.In this case, the complaint was confirmed through provided imagery and returned product evaluation.Available information suggests that procedural factors (altered balloon profile catching on distal tip, excessive manipulation) likely contributed to the reported event.No edwards defect or manufacturing non-conformance that would have contributed to the reported event was identified.No ifu/training deficiencies were identified.Therefore, no further escalation (capa/scar/pra/fca) is required.All complaints are reviewed against control limits which are managed.The complaint sheath damaged was confirmed based on the device evaluation.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.In this case, product evaluation identified presence of hdpe damage/stretching on the sheath shaft.It is possible that the sheath sustained damage during system removal.Retrieving system with an altered balloon profile could lead to increased withdrawal forces, causing the sheath shaft to weaken and stretch.The increased withdrawal forces could also promote adverse interactions between the shaft and patient's vasculature (e.G.Calcification), leading to damage (however, no details were provided with respect to patient's access characteristics).As such, available information suggests that procedural factors (excessive manipulation) may have contributed to the reported event.However, a definitive root cause was unable to be determined at this time.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18673629
• MDR Text Key: 336082879
• Report Number: 2015691-2024-00881
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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: 916ESPA
• Device Lot Number: 65158653
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/11/2024; 04/25/2024
• Supplement Dates FDA Received: 03/28/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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 Sex: Male