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

Model Number 9610ES16

Device Problems Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)

Patient Problem Great Vessel Perforation (2152)

Event Date 07/01/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported, 29mm sapien 3 case by transfemoral approach.During the procedure it was difficult to advance the commander delivery system with crimped valve through the esheath, and the valve protruded through the esheath liner.It was then seen that the descending aorta was punctured just above the bifurcation.The aorta was occluded with a balloon and stents were implanted; however, hemostasis was unsuccessful resulting in the patient's death.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: added new information to h.6 component codes, type of investigation, investigation findings and investigation conclusions.The device was returned to edwards lifesciences for evaluation and the following were observed on the returned sheath: liner tear was found at approximately 20 mm from tip.The tear measured approximately 123 mm in length.The liner was otherwise expanded as designed and sheath shaft damage and tip opened as designed.Imagery was provided from the site and revealed the following: the valve size was a 29mm so a 16f was probably used.Both femorals are not too tortuous, moderately calcified in general but severely calcified at the bifurcation.Thrombus in abdominal aorta.Both femoral do not meet the minimum vessels diameter for a 16f.The e-sheath was inserted in correct position crossing the stenosis but the valve was forced towards the seam that was in the left side of the aorta because of the resistance to the e-sheath expansion created by the plaque.The sheath liner was torn with the delivery system exposed.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaints were confirmed from returned device condition.However, no manufacturing non-conformance was identified on the returned device.Reviews of the dhr, complaint history, and lot history showed no indication a manufacturing non-conformance contributed to the event.No ifu/training manual deficiencies were identified.Furthermore, no abnormalities were noted during device preparation.An existing technical summary written by edwards lifesciences has been documented for root cause analysis on sheath shaft resistance with delivery system complaints.A detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in 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.Patient's access vessels had ''no excessive tortuosity'' as supported by the imaging review which states ''both femorals are not too 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.Patient's access vessel had ''mild/moderate calcification in the iliacs - greater on left side than right''.Imaging review also stated, ''moderately calcified in general but severely calcified at the bifurcation''.Undersized vessels can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Per the imaging review, ''both femoral do not meet the minimum vessels diameter for a 16f''.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.No information was provided regarding the insertion 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.The training manual states, ''push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification''.If high push force was used to overcome any resistance experienced from the patient's undersized vessels and calcification (see above root cause), the delivery system could puncture through the sheath liner resulting in subsequent patient injury.The training manuals state, ''if push force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1-2 cm'', and ''in expectation of high friction, use short movements''.Additionally, the ''severely calcified at the bifurcation'' could have weakened the liner, making it susceptible to damage.The ifu states ''access characteristics such as severe obstructive or circumferential calcification, severe tortuosity, vessel diameters less than 5.5 mm (for size 20, 23 and 26 mm sapien 3 transcatheter heart valve) or 6.0 mm (for 29 mm sapien 3 transcatheter heart valve) may preclude safe placement of the sheath and should be carefully assessed prior to the procedure''.As such, available information suggests that patient factors (calcification, inadequate vessel size) and/or procedural factors (high push force) may have contributed to the reported 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.Therefore, no corrective or preventative action nor product risk 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: 15122106
• MDR Text Key: 296779686
• Report Number: 2015691-2022-07049
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 9610ES16
• Device Lot Number: 64240726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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 Outcome(s): Death
• Patient Age: 78 YR