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

Model Number 914ESA

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/11/2021

Event Type  malfunction  

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, during a transfemoral tavr, a 26mm sapien 3 ultra valve was deployed in the aortic position.Significant resistance was encountered during the advancement of the sapien 3 ultra valve and delivery system.The loader was still engaged, so the physician pushed it in and pulled it out slightly.This helped to reduce the resistance.The valve was deployed where intended without consequence to the patient.After the delivery system was removed, as the esheath was withdrawn, the liner was observed to be damaged - torn with a liner strand.One liner strand was completely detached and had to be removed from the vessel.No vascular injuries were reported.At the time of the report, the patient was in stable condition.The valve remains implanted in the patient.

Manufacturer Narrative

The 14fr esheath was returned to edwards lifesciences for evaluation.Visual inspection revealed curvature along the sheath.The liner was torn and a strand was observed along the length of the sheath, from the distal strain relief to the distal tip.The distal tip was opened as designed with no observed damage on the tip.The sheath shaft had a minor kink on the strain relief 1.5 inches from the comnut.The sheath shaft was folded approximately 0.75 inches from the strain relief end.A long scratch was observed on the distal end of the shaft.No case imagery was provided for review.Dimensional analysis of the liner thickness, measuring along the length of the liner tear and strand, was performed.The liner thickness was within specification.Functional testing was not able to be performed due to the condition of the returned device.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed other similar complaints for the appropriate complaint coded.Complaint history review from (b)(6) 2020 to (b)(6) 2021 for the esheath (all models and sizes) revealed similar events for the associated complaint codes.No edwards device defects were identified in the evaluations.Available information suggests that procedural factors (bent valve strut, damaged valve, excessive manipulation due to difficulties with ds insertion/withdrawal, high push force, improper crimping, incomplete loader advancement, valve strut caught on liner, withdrawal of burst/torn balloon, withdrawal of damaged valve) may have contributed to the complaint event.Since no edwards defect was identified, no corrective or preventative action is required.Sheath liner tears have been previously investigated by edwards and documented in a clinical technical summary written by edwards lifesciences.Relevant complaint data and the summary of the associated engineering evaluations of returned devices performed from (b)(6) 2015 to (b)(6) 2016 are aggregated in this technical summary.Liner tears can occur at some point during expansion of the esheath either during insertion or retrieval of a delivery system or balloon catheter.The length of the liner tear can vary, with lengths spanning small portions of the sheath shaft or across the entire length.This technical summary outlines the current mitigations during the manufacturing process (i.E.Visual inspections and functional evaluations) and in the instructions for use (ifu) and training documents.Based on available evaluation data, clinical input and complaint report trending, the information summarized in this technical summary supports that the sheath liner tear occurring during the use in the patient have had root causes related to patient factors (tortuous patient anatomy/peripheral vessel calcification) and/or procedural factors (non-coaxial retrieval, incomplete deflation) rather than a device non-conformance.During esheath manufacturing, the sheath shaft components are 100% visually inspected under magnification.The final assembled devices are 100% visually inspected under magnification by both manufacturing and quality.In addition to the in-process inspections described above, each manufacturing lot undergoes product verification (pv) testing under a sampling plan before final release.These inspections during the manufacturing process and tests performed during product verification support a conclusion that it is unlikely that a manufacturing non-conformance would contribute to a complaint event.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.In this case, the complaints were confirmed based on the evaluation of the returned device.No manufacturing non-conformances were identified with the returned device.Reviews of manufacturing mitigations, device history record, and lot history supported that a manufacturing non-conformance likely did not contribute to the reported events.Per complaint description, ;significant resistance was encountered during the advancement of the sapien 3 ultra valve and delivery system.' per the training manual, 'push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.' the case notes mention the patient had 'minimal' calcification and tortuosity of the access vessel.Although 'minimal', the presence of calcification within the access vessel can prevent the sheath from fully expanding, increasing the necessary push force to advance the delivery system through the sheath.Scratches were observed along the sheath shaft during visual inspection, indicating the sheath had interacted with calcification.Additionally, tortuosity can result in the creation of sub-optimal angles during delivery system insertion that may lead to non-axial alignment in the advancement of the delivery system.These patient factors, in conjunction with the exposed apices of the crimped sapien 3 ultra valve, may increase the rate of the thv getting caught on the sheath, preventing further advancement.A capa has identified potential areas for sapien 3 ultra valve design/process improvement to mitigate against the failure.As there was no note of abnormalities during device preparation, it is unlikely that the damaged sheath was an issue out of box.The liner tear and strand likely occurred as a result of excessive device manipulation during advancement.Per the complaint description, 'the loader was still engaged, so the physician pushed it in and pulled it out slightly.' as the device was manipulated to overcome the observed resistance and continue to advance forward, it may have resulted in valve interaction with the sheath liner, leading to the observed liner tear and strand.Available information suggests procedural factors (excessive manipulation of the device, valve strut caught on liner), in addition to patient factors (access vessel calcification, tortuosity) may have contributed to the reported liner tear / liner strand.As there was no confirmed edwards defect, no corrective/preventative actions are required.However, after review of the similar reported issues per the product risk assessment, a capa was initiated to investigate issues associated with insertion of the valve through the sheath using the sapien 3 ultra system (sapien 3 ultra thv, commander delivery system, and esheath).

• 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: 11427099
• MDR Text Key: 245039397
• Report Number: 2015691-2021-01728
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193985
• UDI-Public: (01)00690103193985(17)220902(10)63357995
• 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
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: 914ESA
• Device Lot Number: 63357995
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1