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 06/11/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted when additional information is provided.

Event Description

As reported through edwards japan affiliate, after a transfemoral (tf) transcatheter aortic valve replacement (tavr) in the aortic position, following the removal of the sheath, angiography confirmed a dissection of the right femoral artery.A stent was implanted.No patient injury was reported.

Manufacturer Narrative

A supplemental mdr is being submitted due to additional information received.As reported through the japanese tavi case registry, prolonged hypotension was observed during the transfemoral tavr for a 23mm sapien 3 valve.After the valve was implanted, hypotension occurred.The cardiac massage was executed, and vasopressor was given.Eleven (11) minutes later, the blood pressure recovered.On postoperative day (pod) 1, consciousness was not clear.Ct did not reveal apparent infarct and it was considered as hypoxic ischemic encephalopathy.The consciousness was eventually recovered, and the patient underwent rehabilitation.On pod 42, the outcome was determined as recovered.Per the medical opinion, the event was determined as related to both the device and the procedure.Seriousness was reported as serious.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.The device was not returned, and no imagery evaluation was performed.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 this adverse event is not required at this time.The complaints were unable to be confirmed due to no imagery/device provided.An edwards lifesciences technical summary has been documented for root cause analysis on sheath shaft resistance with delivery system complaints.As the device was not returned, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing non-conformance was unable to be determined.However, review of the device history records, and lot history did not provide any indication that a manufacturing nonconformance would have contributed to the complaint event.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in the technical summary.The technical summary provides details of contributing factors for increased resistance during insertion and advancement of the delivery system through the sheath.The following vessel characteristics and procedural factors were identified as the root causes for encountering increased resistance: tortuous vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.There was no access vessel tortuosity reported.Calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.It was reported that the patient had moderate to severe access vessel calcification.Undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.It was reported that the patient's access vessel minimum luminal diameter (mld) was 5.0mm which is below the required 5.5mm for 14f esheath.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.There was no evidence of steep insertion angle.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with an esheath resistance with delivery system.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing nonconformance contributed to the complaint.Calcification and undersized vessels can both create a restricted pathway or constrained condition resulting in difficulty inserting sheath, thereby increased difficulty during device insertion.As such, available information suggests that patient factors (calcification, undersized vessel) may have contributed to the reported event.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.Since no edwards defect was identified, no corrective or preventative action nor product risk assessment escalation is 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: 14918821
• MDR Text Key: 295272769
• Report Number: 2015691-2022-06625
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194838
• UDI-Public: (01)00690103194838(17)240316(10)64280871
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: 914ESJ
• Device Lot Number: 64280871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female