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

Model Number 914ESJ

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During the transsubclavian tavr for a 23mm sapien 3 valve, sheath distal tip torn was observed.There was no resistance noted during insertion.The valve was implanted without trouble.After the sheath was removed, it was confirmed that the distal tip was torn in a circumferential direction.There was no vascular complication.The access vessel had tortuosity but no calcification.Physician stated that the cause is likely due to the valve alignment that had to be executed at the ascending aorta where it is not spacious.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h3, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was returned to edwards lifesciences for evaluation.The visual inspection of the returned sheath revealed the following: the liner was fully expanded.The tip opened along the axial score line as designed.A radial tear was confirmed at the distal edge of the liner seam.There were score lines present and stretching on the hpde.Dimensional and functional testing were unable to be performed due to condition of the returned device (distal tip torn).Due to no imagery being returned, an imagery review was unable to be performed.This event reports a distal tip tear during delivery system insertion and advancement that has not resulted in a patient harm, or a device failure to perform its function.Also, there was no evidence of product non-conformances or labeling/ifu inadequacies identified in the evaluation.Therefore, it is not included in the risk management file.Edwards continues to monitor complaint history on a monthly basis.Therefore, the review of risk management file is complete, and no further action is required at this time.The complaints sheath distal tip torn was 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, -sheath distal tip torn was observed.There was no resistance noted during insertion.The valve was implanted without the trouble.After the sheath was removed, it was confirmed that the distal tip was torn in circumferential direction.- per evaluation of the returned device, the sheath distal tip was observed to be torn radially along the distal edge of the liner.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, follow-up information revealed that -the access vessel had tortuosity, no calcification.- 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, leading to the tear of the tip.A capa was previously opened to capture the investigation of this type of events.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity) may have contributed to the complaint events.However, a definitive root cause was unable to be determined at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

• 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: 15084125
• MDR Text Key: 303641166
• Report Number: 2015691-2022-06950
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)240216(10)64227618
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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 Expiration Date: 02/16/2024
• Device Model Number: 914ESJ
• Device Lot Number: 64227618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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 Age: 90 YR
• Patient Sex: Male