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

Model Number 914ESPA

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

Patient Problem Unspecified Vascular Problem (4441)

Event Date 10/10/2022

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist during a right transfemoral tavr, the valve was successfully deployed.At some point in the procedure, a vessel laceration occurred.A cutdown to repair the vascular injury was performed.The patient remained stable throughout and the cutdown and the esheath appeared damaged.The patient recovered well and was discharged.Per images provided, the liner was torn and there appeared to be strain relief damage.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.Device pending return.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The esheath+ was visually inspected and the following was observed: there was slight curvature on sheath shaft.The distal tip was opened as designed.The liner was fully expanded.The liner was torn entire length from strain relief to distal tip.The distal end of the strain relief was torn along the liner fold, approximately 0.25" in length.The strain relief was cut by engineer to inspect the underneath: liner tear starts about 2" from com-nut.The liner thickness was measured at three locations along the length of the tear.Measurements were taken on one side only, due to the nature of the tear.All measurements were found to meet specification.The provided imagery was reviewed and the following was observed: adequately sized vessel with calcification and tortuosity present in access vessel (right femoral).Post-procedural device photo, showing liner and strain relief tears.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 complaint of strain relief damage was confirmed through evaluation of the returned device and procedural imagery.However, no manufacturing non-conformances were identified during evaluation of the complaint device.Reviews of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.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, there was no report of any issue with the sheath during device unpacking or preparation.Per the complaint event, ''during a right transfemoral tavr, the valve was successfully deployed.During the procedure, there was no difficulty inserting the esheath into the patient and no difficulty inserting the delivery system though the sheath.There was no difficulty retrieving the device through the sheath tip and no difficulty withdrawing the sheath.The patient suffered a vessel laceration and the physician believed it originated from the esheath.The vascular surgeon came in and did a cutdown to repair the vascular injury.The esheath appeared damaged and the physician believed that this was the cause for the vascular complication.'' per review of the provided imagery, the access vessel (right femoral) was adequately sized (>5.5mm for 14f sheath) and had calcification and tortuosity present.Post-procedural device photos showed that the sheath liner and strain relief were torn.Per evaluation of the returned device, the sheath shaft was slightly curved.The distal tip was opened as designed and the liner was fully expanded and torn from the strain relief to the distal tip.The distal end of the strain relief was torn along the liner, approximately 0.25" in length.The strain relief was cut by engineering to inspect underneath.The liner tear was observed to start about 2" from the com-nut.As the liner tore underneath the strain relief in the distal portion and the strain relief tore at the liner fold, it is possible that as added internal forces were experienced on the liner and subsequently the strain relief, that damage could occur.This coupled with any excessive interaction with the native vasculature could contribute to sheath damage.As such, available information suggests that procedural factors (excessive manipulation, valve interaction with liner) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.No labeling/ifu deficiencies were identified.Therefore, no further escalation (capa/scar/pra) 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.

• 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: 15740128
• MDR Text Key: 303142198
• Report Number: 2015691-2022-09049
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240531(11)2206012164405122
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 914ESPA
• Device Catalogue Number: N/A
• Device Lot Number: 64405122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female