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

Model Number 9610ES16

Device Problems Patient-Device Incompatibility (2682); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Edwards received notification from our affiliate in spain.As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve, in aortic position by transfemoral approach.The patient had a history of severe aortic stenosis (as) and severe calcification and tortuosity in both iliac arteries.It was decided to access through the left femoral artery and a balloon pre-dilation was performed.During the introduction of the esheath it was not able to navigate.The sheath was removed and a new sheath was inserted.The valve was implanted successfully and the patient was stable.Post procedure images of the esheath were provided and showed a distal tip split.

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.A review of imagery was performed, and the following was observed: tortuosity present in patient's access vessel.Distal tip was open and split along the hdpe proximal to the axial score line.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this event.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 complaints of esheath distal tip split and sheath insertion inability were confirmed through evaluation of the 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.However, review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.As reported, ''the patient had severe aortic stenosis and severe calcification and tortuosity in both iliac arteries.It was decided to access through the left femoral artery and a bav was performed.Then, during the insertion of the esheath it was not possible to navigate.The esheath was removed, replaced with a new esheath which could be correctly inserted''.The patient was noted to have ''severe calcification and tortuosity''.Tortuous patient anatomy can also be observed in the returned patient imagery.The procedural training manual states, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.It is likely that vessel calcification and tortuosity created a challenging pathway for sheath insertion through added friction from interaction with calcification and sub-optimal angles from tortuosity, which may have required additional force and device manipulation to overcome.Sheath interaction with calcification coupled with excessive manipulation can cause the sheath tip to split.As such available information suggests that patient (calcification, tortuosity) and/or procedural (excessive manipulation) factors may have contributed to the reported event.No labeling/ifu deficiencies were identified.Therefore, no corrective or preventative actions, nor product risk assessment (pra) is required 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.

Manufacturer Narrative

Supplemental report submitted to include device return and evaluation.Updated h6 and h10.The returned device was visually inspected, and the following was observed: the sheath was unexpanded.The sheath distal tip was noted to be prematurely opened with the liner lifted near it.The sheath distal tip was split.Scratches along the shaft were noted.The complaints of esheath distal tip split and sheath insertion inability were confirmed through evaluation of the provided imagery and returned device.

• 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: 14688722
• MDR Text Key: 294578477
• Report Number: 2015691-2022-06197
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64040159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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: 71 YR
• Patient Sex: Male