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

Model Number 914ESA

Device Problem Difficult to Advance (2920)

Patient Problem Intimal Dissection (1333)

Event Date 10/12/2020

Event Type  Death  

Manufacturer Narrative

Udi: (b)(4).This individual report provides data received from the thv/tvt registry.Investigation for this event is ongoing.

Event Description

Per the field clinical specialist (fcs), during a left tf tavr procedure, there was difficulty advancing the 14 fr esheath into the aorta.The access vessel minimum luminal diameter measured 7mm with circumferential calcium.The access vessel had been pre-dilated with a 10mm balloon. during insertion of the 26mm sapien 3 valve through the esheath, they could not get the valve past the level of the left common iliac artery.The valve and esheath were removed and the case was aborted.There was a vascular injury, and the patient required fem-fem bypass grafts.The patient expired 2 days post procedure, the cause of death is unknown at this time, however, edwards lifesciences is reporting as best practices.Upon removal of the esheath, there were no abnormalities observed on the device.It was clarified that the loader had not been inserted at a steep angle, and that the resistance was experienced when the delivery system was ¿almost to the tip of the sheath¿.

Manufacturer Narrative

The device was not returned for evaluation.As per visual observation by edwards engineering team of the patient¿s screening imagery provided by the facility, the access vessel (left femoral and iliac arteries) had presence of calcification and an undersized minimal luminal diameter (mld) of 4.2mm.Vessel diameters of 5.5mm or larger are required for safe used of the 14f esheath.Access vessel had presence of tortuosity.A review of the device history report (dhr) performed did not reveal any manufacturing nonconformance that would have contributed to this complaint.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 for sheath shaft resistance with delivery system was unable to be confirmed.Due to unavailability of the device, engineering was unable to be perform any visual, functional, or dimensional analysis.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in a technical summary written by edwards lifesciences.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.Per imagery provided, the patient¿s access vessel was tortuous.-calcification can reduce the vessel diameter and may increase restriction leading to resistance.It can also result in the creation sub-optimal angle during delivery system insertion that may lead to resistance.Per the imagery provided, the patient¿s access vessel had circumferential calcification.-undersized vessel can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Per the imagery provided, the patient¿s access vessel was smaller than required.-steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which during advancement may lead to resistance.However, according to the case notes, it was reported that the sheath was not inserted at a steep 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 non-conformance contributed to the complaint.As such, available information suggests that patient factors (calcification, tortuosity, vessel size) may have contributed to the reported resistance with the delivery system, which likely contributed to the vascular injury.There were no evidence of any product non-conformances or labeling/ifu inadequacies identified in the evaluation.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.Therefore, no product risk assessment nor corrective or preventative action 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
• MDR Report Key: 10803747
• MDR Text Key: 215132205
• Report Number: 2015691-2020-14296
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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: 04/16/2022
• Device Model Number: 914ESA
• Device Lot Number: 63443020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 73 YR