MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9610ES16

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), the transfemoral deployment of a 29mm sapien 3 valve in an existing valve in the mitral position was planned.During the advancement of the initial sapien 3 valve and commander delivery system, the guidewire position was lost from the left ventricle (lv).The devices were removed.A new valve, delivery system and sheath were prepared.During the second attempt, 'insufficient insertion of esheath' resulted in damage to the sheath liner.The delivery system couldn't be advanced or be retrieved.The delivery system, valve and sheath were removed by a surgeon.A third valve, delivery system and sheath were prepared and successfully used for the procedure.A patch was then used to repair the femoral vein for the cutdown.At the time of the report, the patient was doing well.It was speculated that the too high insertion during the first attempt was responsible for the loss of the guidewire position from the ventricle.Based on this, a minimal insertion was tried during the second attempt.

Manufacturer Narrative

Update to d9, h3, h6 and h10 to reflect device evaluation.The esheath was returned to edwards lifesciences for evaluation.Visual inspection revealed the following: the liner was torn on the returned proximal position of the cut sheath shaft, after the strain relief was removed by the engineering, the liner was observed torn underneath, minor scuffs were noted on the sheath shaft and the associated delivery system's flex shaft was kinked 1.5 cm and 3 cm from the nose tip.Functional testing was unable to be performed due to the condition of the returned device (sheath shaft cut).Dimensional testing was performed on the sheath liner thickness along the liner tear and met liner thickness specifications.During manufacturing all inspections are conducted on 100% of the units.The entire device is visually inspected and dimensionally testing during the manufacturing process.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history record review was performed and did reveal related complaints.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.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 for resistance between components, sheath liner torn, difficulty introduction the sheath, and withdrawal difficulty removing the sheath were confirmed.No manufacturing non-conformances were identified through evaluation of the returned device.A review of the device history record, complaint history, and lot history supported that a manufacturing non-conformance likely did not contribute to the reported events.Per ifu and training, the sheath temporarily enlarges to allow the passage of devices; ensure that the vasculature can accommodate the maximum diameter of the expand sheath.When inserting, manipulating or withdrawing a device through the sheath, always maintain sheath position.When puncturing, suturing or incising the tissue near the sheath, use caution to avoid damage to the sheath.Using standard catheterization techniques, gain access to the vessel and dilate as necessary with the other to accommodate the sheath.Orient the sheath appropriately and maintain orientation throughout the procedure.Insert the sheath assembly using standard technique and advance into the vessel while following its progression under fluoroscopy.Use stiff wire (for peripheral access only) in case of peripheral tortuosity.Apply tension to wire to provide firm rail for placement.Always observe fluoroscopy during insertion.Proper screening is critical to reducing vascular complications; know position of sheath tip in the aorta.Delivery system insertion through sheath: correctly orient delivery system and check position before insertion, orient the delivery system with the flush port pointing away and the edwards logo facing up, ensure delivery system is locked in default position.Note: maintain edwards logo up throughout the procedure to prevent kinking of the delivery system.Insertion force through sheath: insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification, if push force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm.Note: in expectation of high friction, use short movements.If working length is insufficient, peel away the loader tube and remove while maintaining delivery system and wire position.Sheath removal: remove the suture securing the sheath, remove the sheath entirely without torquing ensuring the edwards logo is facing upwards.A review of ifu/training materials revealed no deficiencies.Per report, 'it was thought the too high insertion by first try was responsible of guidewire loss from the ventricle.So minimal insertion was tried.The ds couldn't either advance or be retrieved.' the case notes revealed the patient's access vessel was tortuous.Per the training manual, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' the presence of the tortuosity within the access vessel can create a constrained condition and likely contributed to difficulty inserting the sheath into the patient and difficulty advancing the delivery system through the sheath.Tortuosity may result in a non-coaxial insertion, further contributing to insertion difficulties of the sheath and advancement of the delivery system.The liner tear likely occurred due to excessive device manipulation during advancement of delivery system.As the delivery system was manipulated to overcome the observed resistance during device advancement, it may have resulted in valve strut interaction with the liner, leading to the observed tears.Upon removal of the sheath, the valve was likely exposed through the torn liner.The exposed valve can create a larger profile of the sheath, which can subsequently result in withdrawal difficulties.This potentially caused the reported withdrawal difficulty felt by the physician.Furthermore, the access vessel tortuosity may contribute to a non-coaxial withdrawal of the sheath, further contributing to the reported withdrawal difficulty.In this case, available information suggests that patient factors (tortuosity) and procedural factors (excessive manipulation, valve caught on liner and altered sheath profile) may have contributed to the complaint event.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.No manufacturing non-conformances were identified during evaluation.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• 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: 12981061
• MDR Text Key: 286499180
• Report Number: 2015691-2021-06772
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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
• Report Date: 02/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 63629411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 71 KG