MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 9610ES14

Device Problems Peeled/Delaminated (1454); Material Puncture/Hole (1504); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The device has not been returned.

Event Description

As reported, it was a case of an implant of a 26mm sapien 3 ultra transcatheter heart valve, in aortic position by transfemoral approach.During procedure, resistance was felt while advancing the delivery system through the esheath.Greater force was exerted to advance up towards the common iliac.It was observed in fluoro that the esheath was split and the delivery system exited the esheath.It was not possible to retrieve the valve fully back into the esheath or advance it.It was decided to further split the esheath to allow the valve to came out of the esheath.Due to the resistance, the valve looked a bit lopsided, slightly off position.It was decided to implant the valve as it was thought to be not damaged.The valve was deployed successfully.Then, the delivery system and the esheath were removed separately without resistance.Patient is recovering well.No patient injury.Based on the imagery provided, the sheath had split and liner strand was noted.There were no missing pieces.A per medical opinion, the vascular anatomy and calcification was responsible for the sheath split as friction felt on advancement.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information.Additional device code was added based on preliminary decontamination.The investigation is ongoing.

Manufacturer Narrative

The device was returned to edwards lifesciences for evaluation and the following was observed.Sheath shaft curvature.Liner torn for 16cm in length starting from distal tip.Three liner strands present along the liner tear each with length of 5cm, 1.5cm, and 0.5cm, respectively.Distal tip opened as designed but soft tip was damaged.Hdpe stretching and scratches along length of shaft.Imagery was provided from the site and revealed the following: post-procedural device photo showed sheath shaft is curved, introducer is exposed through torn liner, and liner strands are present.Fluoroscopy videos showed delivery system and crimped valve appear to be located outside the sheath shaft, suggesting a torn sheath liner.Delivery system and crimped valve shown before and after ''jumping, after greater force exerted''.3mensio showed calcification is present along the iliac and tortuosity is also present along the iliac with adequately sized vessel diameters.During manufacturing, the device undergoes multiple inspections.In addition, the work order underwent functional product verification testing as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaints were confirmed through evaluation of the returned device and procedural imagery.However, no manufacturing non-conformances were identified during evaluation of the complaint device.Reviews 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 manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issue with the sheath during device unpacking or preparation.In this case, ''during procedure, resistance was felt while advancing the delivery system through the esheath.Greater force was exerted to advance up towards the common iliac.It was observed in fluoro that the esheath was split and the delivery system exited the esheath.It was not possible to retrieve the valve fully back into the esheath or advance it.It was decided to further split the esheath to allow the valve to came out of the esheath.Due to the resistance, the valve looked a bit lopsided, slightly off position.It was decided to implant the valve as it was thought to be not damaged.The valve was deployed successfully.Then, the delivery system and the esheath were removed separately without resistance.Patient is recovering well.No patient injury.Based on the imagery provided, the sheath had split and liner strand was noted.There were no missing pieces.A per medical opinion, the vascular anatomy and calcification was responsible for the sheath split as friction felt on advancement.Difficulty advancing and distal tip damage: per review of returned imagery, the delivery system and crimped valve appear to be located outside the sheath shaft and appear to ''jump'' after greater force was exerted, as reported.The sheath shaft was also curved, the introducer exposed through the torn liner, and liner strands were present.Lastly, calcification, tortuosity, and adequately sized vessel diameters are present along the access vessel.Per visual inspection of the returned device, sheath shaft curvature was observed.The liner was torn for 16cm from the distal tip.Three liner strands were observed along the torn liner: 5cm, 1.5cm, and 0.5cm in length.The sheath distal tip was opened as designed and had soft tip damage.In addition, there was stretching and scratches on the sheath shaft.Per the training manual, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification.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.'' calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also damage the outer sheath and sheath liner, potentially contributing to the observed distal tip and liner damage.Tortuous vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system and further contribute to the reported resistance and observed sheath damage.In addition, if excessive manipulation and high push force were used to overcome the resistance, this may have further contributed to the sheath damage observed.Lastly, as the delivery system and crimped valve were outside of the sheath through the torn liner during advancement, this may have further damaged the distal tip and created the liner strands as it was continued to be advanced.Liner punctured: an existing technical summary written by edwards lifesciences 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 / procedural factors (e.G.Access vessel tortuosity / calcification or withdrawal of a burst or torn balloon) are likely the contributing factors for sheath shaft liner tears.Per evaluation of the returned device, the sheath liner was torn for 16cm in length starting from distal tip.Review of imagery shows calcification and tortuosity within the access vessel.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tearing or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.Vessel angulation can create suboptimal angles during delivery system advancement through the sheath.The delivery system or balloon catheter can potentially catch on to liner of the sheath and lead to liner tears upon removal.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with sheath shaft liner tears.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.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.As such, 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) and/or procedural factors (excessive manipulation) may have contributed to the complaint events.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 and to address the issue and no corrective or preventative action assessment is required at this time.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• 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: 16011757
• MDR Text Key: 306247501
• Report Number: 2015691-2022-10160
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

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 Model Number: 9610ES14
• Device Lot Number: 64466495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/09/2023; 02/24/2023
• Supplement Dates FDA Received: 01/09/2023; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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 Age: 84 YR