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

Model Number 916ESA

Device Problems Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.

Event Description

Edwards received notification from a thv territory manager that during a right transfemoral tavr, there was resistance during insertion of the 29mm sapien 3 valve into the 16fr esheath.Fluoro images showed that the esheath was perforated and the devices were surgically removed.As reported, the patient had severe tortuosity in external iliac artery.Multiple sheaths were required to ultimately get up with the esheath.Once the esheath was placed, a 29mm commander delivery system was prepped and inserted into the esheath.Difficulty pushing the valve through the esheath was experienced and ultimately the esheath and delivery system were observed to be kinking.The delivery system was not moving forward though the esheath at the level of the external iliac artery.The difficulty was experienced approximately halfway into the esheath.Fluoro pictures seemed to show that the sheath was perforated.The undeployed thv appeared to be herniated through the side of the esheath.The system was unable to be advanced or removed.The procedure was stopped and vascular surgery was called.The patient remained stable and was taken to vascular or for surgical removal of the devices.The esheath was destroyed during surgical removal.There was no frame damage observed on the valve.No pictures are available and the devices are not available for return.The patient had a highly tortuous vessel with minimal lumen diameter (mld) at 5-5.5mm.

Manufacturer Narrative

The device was not available for return per the field clinical specialist.Therefore, a no product return engineering 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 the failure mode is not required at this time.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.The complaints were unable to be confirmed as the device nor applicable imagery was provided.No manufacturing nonconformance was identified during the evaluation.A review of the device history records did not provide any indication that a manufacturing non-conformance would have contributed to the events.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in an edwards lifesciences 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.Complaint description states that the patient's access vessel was 'highly tortuous'.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.Undersized vessel can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.The patient's minimal lumen diameter (mld) was 5-5.5mm, which is under the size necessary for safe use of the 16f esheath (greater than or equal to 6.0mm).Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.Consequently, if high push was used to overcome the resistance, the sheath could buckle and kink.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 resistance advancing the delivery system into the sheath and the sheath kink.As such, available information suggests that patient factors (tortuosity and undersized vessel) and/or procedural factors (high push force) may have contributed to the reported event.No labeling or ifu inadequacies have been identified.Since no edwards defect was identified,no corrective or preventative action is required.Regarding the complaint of sheath liner torn, an existing edwards lifesciences technical summary has been documented for root cause analysis on sheath shaft liner tears with normal liner expansion.In this technical summary, a review of liner tear complaint investigations on returned devices over a two-year period found that patient and/or procedural factors (e.G., access vessel tortuosity, calcification, withdrawal of a burst or torn balloon) are likely the contributing factors for sheath shaft liner tears.The complaint description states that the patient's access vessel was 'highly tortuous'.Tortuous patient anatomy can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.The delivery system can thereby catch on the sheath liner of the sheath resulting in a torn liner if high push force is used.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and that the mitigations in place during manufacturing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.Available information supports that patient factors (tortuosity) and/or procedural factors (high push force) likely led to the sheath liner tear and there is no evidence of device malfunction or manufacturing non-conformance.No labeling or ifu inadequacies have been identified.Since no edwards defect was identified, no corrective or preventative action is required.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.

• 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: 12611814
• MDR Text Key: 277615659
• Report Number: 2015691-2021-05623
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193992
• UDI-Public: (01)00690103193992(17)230510(10)63779116
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: 916ESA
• Device Catalogue Number: N/A
• Device Lot Number: 63779116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2021
• 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 Sex: Male