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

Model Number 914ESPA

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Per the field clinical specialist (fcs), during a tavr procedure with a 23mm sapien 3 ultra valve using transfemoral approach, more resistance was felt than usual at the distal tip of the esheath plus when advancing the valve and the delivery system through.The valve was deployed without complication and no patient harm known.However, when the sheath was removed there appeared a larger then usual "tear" appearance in the distal tip.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information based on investigation.The following sections of this report have been updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The esheath plus was returned to edwards lifesciences for evaluation.The returned device was evaluated, and the following was observed: the liner was fully expanded as designed, scratches were visible along the shaft, distal tip was torn radially along liner edge and not opened along axial score, all score lines present, stretching was observed along tip tear and gouge mark on the inner diameter of the torn piece.The 3mensio imagery review was performed and the access vessel tortuosity and calcification were observed particularly near the bifurcation.Due to condition of the returned device (distal tip torn), no applicable functional or dimensional testing was able to be performed.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed complaints relating to the complaint code.However, lot history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.The esheath+ ifu, commander delivery system ifu, and device preparation manual instructions for use (ifu) were reviewed.The device preparation manual provides guidance on vascular access.Access characteristics that would preclude safe placement of the sheath such as severe obstructive calcification, severe tortuosity or vessel diameters less than the minimum recommended should be carefully assessed prior to the procedure.Valve size of 20-26mm, sheath 14f, recommends that the minimum vessel diameter greater than or equal to 5.5mm.Based on this review, no ifu training deficiencies were identified.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.Manufacturing mitigation review was performed, and all inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.Based on this review it is unlikely a manufacturing non-conformance contributed to the reported complaint.The complaints for sheath distal tip torn and difficulty advancing through sheath were confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the complaint description, "more resistance was felt than usual at the distal tip of the esheath plus when advancing the valve and the delivery system through".Per evaluation of the returned device, the sheath distal tip was observed to be torn radially.The failure mode is characteristic of sheath tip tear events as described in a product risk assessment.While a definitive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.Additionally, 3mensio imagery was also provided and shows the presence of access vessel tortuosity and calcification near the bifurcation.Additionally, scratches and curvature were present along the returned shaft, which are indicative of interaction with calcification and tortuosity, respectively.Per the training manual, "push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification".Calcification and create a constrained condition at the distal tip, while tortuosity can lead to non-coaxial alignment between the crimped valve and the sheath, which may lead to the valve struts to catch onto the sheath distal tip increasing resistance during advancement and tearing the tip.In this case, the failure mode may be related to improper expansion of the sheath tip during valve advancement and/or patient factors (calcification, tortuosity) may have contributed to the complaint events.However, a definitive root cause was unable to be determined 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.No ifu/labeling/training manual inadequacies were identified.This the issue has been previously identified in product risk assessment (pra) and a capa.

• 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: 14135697
• MDR Text Key: 289467276
• Report Number: 2015691-2022-05197
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240112(11)2201122164183828
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64183828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female