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

Model Number 914ESJ

Device Problem Difficult to Insert (1316)

Patient Problem Vascular Dissection (3160)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.Device was discarded at the facility.

Event Description

As reported by an edwards lifesciences affiliate in (b)(4), during a transcatheter aortic valve replacement procedure with a 23mm sapien 3 valve, the operator experienced insertion difficulty in patient while using the sheath.Upon removal of the sheath, a digital subtraction angiography (dsa) revealed dissection from the aortic bifurcation to left the common iliac artery (cia).A stent was placed for the dissection.

Manufacturer Narrative

Updated b4, g3, g6, h2, h6 and h10 to reflect no product evaluation.The device was not returned.As no device was returned, no functional testing, dimensional testing or visual inspection could be performed.No imagery was returned for review.The work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the related work order was performed and revealed no other complaints relating to the relevant complaint codes.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The commander and sapien 3 ifu, preparation training manual, and procedural training manual were reviewed.The ifu cautions ''do not use the thv in patients with access vessel diameters <5.5mm for 20/23/26 mm systems.'' no ifu/training deficiencies were identified.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 event was unable to be confirmed without the returned device or procedural 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 and lot 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, ''14 fr esheath was inserted and got stuck by calcification''.Per the training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification''.Additionally, the minimum vessel diameter should measure greater than or equal to5.5mm for a 14 fr esheath.Per the case notes, ''access vessel calcification was moderate, tortuosity did not exist.Mld was 3.9 mm''.Calcification and undersized vessel diameters can create a constrained condition and lead to increased contact with the sheath.These factors can increase friction between the sheath and the patient's access vessel leading to difficulty during sheath insertion.Available information suggests that patient factors (calcification, undersized vessel) likely contributed to the reported event.In this case, a vascular dissection occurred and was possibly due to procedural factors (device manipulation) and/or moderate calcification of the access vessel that may have contributed to the complaint event.Since no product non-conformances or ifu/training manual deficiencies were identified, no escalation to a pra was required.Since no edwards defect was identified, no corrective or preventative actions are required.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 on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, 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: 13817177
• MDR Text Key: 288601383
• Report Number: 2015691-2022-04484
• Device Sequence Number: 1
• Product Code: NPT
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Model Number: 914ESJ
• Device Lot Number: 64050735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: Female