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

Model Number 9610ES14

Device Problems Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem Vascular Dissection (3160)

Event Date 08/11/2022

Event Type  Injury  

Event Description

As reported, it was a case of an implant of a 20mm valve, in aortic position by transfemoral approach.During the delivery system insertion, a resistance was noted at the end of the sheath and the valve was stuck.After multiple attempts, the valve successfully passed through the esheath.The valve was deployed smoothly.Upon removal of the delivery system and esheath, no flow in the left femoral (access site) was noted and the distal tip of the esheath was torn.Left femoral artery dissection occurred and was treated by a cover stent.Patient is hemodynamically stable.

Manufacturer Narrative

The investigation is ongoing.The device has not been returned.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: access vessel luminal diameter was undersized.Minimum luminal diameter (mld) for 14f esheath is 5.5mm.Tortuosity was present in patient's access vessel.After removal from the patient, the sheath distal tip was torn but the sheath was fully expanded.During manufacturing, the device undergoes multiple inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed per evaluation of the returned imagery.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.Review of the dhr and lot history showed no indication a manufacturing non-conformance contributed to the event.Review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were noted during device unpacking or preparation.Per the complaint description, ''during the delivery system insertion, it was felt a resistance at the end of the sheath and the valve stuck there.After many attempts, the valve successfully passed through the esheath.The valve was deployed smoothly.After removing ds and esheath, it was noticed that there was no flow in the left femoral (access site) and the esheath was damaged as per the attached picture.'' per evaluation of the returned imagery, the sheath distal tip was observed to be torn radially along the distal edge of the liner.The failure mode is characteristic of sheath tip tear events as described in product risk assessment (pra).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 an undersized and tortuous access vessel near the aortic bifurcation.Per the training manual, ''push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification''.Undersized vessel diameters can reduce the vessel lumen diameter and create a constrained condition, 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.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity, undersized vessel) 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.A product risk assessment (pra) was previously initiated and to address the issue, a corrective action preventative action (capa) was previously initiated to pursue potential process improvement.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: added new information to d.4 lot number and expiration date and h.4 manufacturer date.The investigation is ongoing.

• 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: 15330926
• MDR Text Key: 299042264
• Report Number: 2015691-2022-07638
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2024
• Device Model Number: 9610ES14
• Device Lot Number: 64162396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2022
• 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