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

Model Number 914ESA

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

As reported, during the procedure of a 26 mm sapien 3 ultra valve in the aortic position via transfemoral approach, the initial valve was damaged during sheath insertion and could not be safely retrieved.A distal tip split and a liner torn were noted during engineering evaluation.A second valve was prepped and successfully deployed in the native annulus.The patient is stable and doing well.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and added new information to h.6 type of investigation and investigation findings.The esheath was returned to edwards lifesciences for evaluation.The following was observed: the sheath shaft had some curvature, the sheath seam expanded as designed near the distal tip.The distal tip was opened as designed, soft tip damage, sheath distal tip split, scratches along the shaft, two liner tears were present, first tear was located 1.25 inches from the sheath housing with a length of 8.25 inches, second tear was thin, connected on both sides, and located at the same location as the first tear with a length of 1.5 inches and flex tip gouges were observed on the associated delivery system.Imagery was provided for review and the patient's access vessel had presence of calcification was observed.During manufacturing of the esheath, the esheath and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.The instructions were reviewed instruction for use (ifu) for esheath, ifu for commander delivery system with s3/s3u, device preparation manual, procedural training manual and no ifu/training deficiencies were identified.The procedural training manual has provided guidelines and instructions to physicians on how to properly handle, prepare, and use the thv and system in the ifu and training materials.The users are instructed on how to screen patients to ensure adequate vessel access and to reduce vascular complications.In addition, a step-by-step instruction on how to insert and advance a delivery system through the sheath including mitigation steps and best practices to address high push force are provided.The users are instructed to correctly orient and lock the delivery system in default position before insertion and for the loader to be fully advanced into the sheath.Insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion, and in expectation of high friction, use short movements and push delivery system closer to sheath hub.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 1-2 cm while advancing the thv/delivery system.If push force is too high or valve and sheath are damaged or valve is still stuck, remove valve and sheath together as a single unit and replace, and do not over-manipulate the sheath at any time.In case of vascular injury, vascular complication management instructions are included for resolution.A review of the risk management documentation was performed, and 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 difficulty advancing through sheath, sheath liner torn and sheath distal tip split were confirmed through evaluation of the returned device.However, no manufacturing nonconformances were identified during the evaluation.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.A review of ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.Per the complaint description, ''difficulty was experienced in the vicinity of the transition from the grey, contiguous portion of the sheath to the expandable portion of the sheath (approximately the entry point or just inside the vessel)''.Per imaging evaluation, the patient's access vessel had presence of calcification.Per the procedural training manual, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' the returned device showed deep scratches along the shaft and soft tip damage, which are indicative of contact with sharp calcified nodules within the access vessel.Vessel calcification can create a challenging pathway for delivery system insertion/advancement through the sheath, as it can create a constrained condition and prevent the sheath from fully expanding during the advancement of the delivery system, increasing the necessary push force to advance the delivery system through the sheath.Per evaluation of the returned device, the sheath liner had two tears.As the patient's access vessel had presence of calcification as evidenced by the scratches along the sheath shaft and provided imagery, sharp calcified nodules may have contacted the sheath liner, weakening, or directly tearing it.Additionally, as the associated crimped valve was shown to have a bent strut, it is possible that the strut made contact with the sheath liner and tore it during device manipulation to overcome the delivery system insertion difficulty through the sheath.Per evaluation of the returned device, the sheath distal tip was split.As the patient's access vessel had presence of calcification as evidenced by the scratches along the sheath shaft and provided imagery, calcified nodules may have also come into contact with the sheath distal tip, splitting it.This may have been exasperated with the any potential device manipulation applied to overcome the experienced resistance during delivery system insertion/advancement.As such, available information suggests that patient (calcification) and/or procedural (valve caught on liner, excessive manipulation) factors 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.A product risk assessment (pra) was previously initiated to investigate the cause and assess the risks associated with high push force of the commander delivery system with s3u through the esheath.To address the issue, a corrective action preventative action (capa) was initiated to drive corrective actions.The capa has been initiated to capture further investigation and corrective/preventative action activities associated with insertion of commander delivery system with s3u through the esheath resulting in high push force.

• 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: 12791666
• MDR Text Key: 284996290
• Report Number: 2015691-2021-06247
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)230324(10)63694696
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2023
• Device Model Number: 914ESA
• Device Catalogue Number: 914ESA
• Device Lot Number: 63694696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2021
• 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 Sex: Male