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

Model Number 914ESPA

Device Problems Material Puncture/Hole (1504); Failure to Advance (2524); Malposition of Device (2616); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/03/2023

Event Type  Injury  

Event Description

As reported by the field clinical specialist (fcs), during implant of a 26mm sapien 3 ultra resilia valve in the aortic position, when pushing the valve through the sheath the team encountered resistance.Fluoro then panned down to valve in sheath showing that the sheath was bent.Lubricant was used, and the valve was eventually able to advance through the sheath, however on fluoroscopy it appeared the sheath split and the valve separated from the catheter with the valve appearing on the outside of the sheath.The team was unable to advance the valve past the distal tip of the sheath.By slowly inflating the balloon, the distal tip of the sheath was torn, however they were able to pull back the sheath and deploy the valve in the abdominal aorta.The case was then aborted.

Manufacturer Narrative

Investigation is ongoing.Device not returned.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from a product investigation.The product was not returned; therefore, a no product return investigation was completed.As a device was not returned, visual inspection, functional testing, and dimensional testing were unable to be done.Provided imagery was reviewed and the following were observed: the associated crimped valve punctured through the sheath liner and the sheath shaft also appears to have some curvature.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.The esheath+ and commander ifu's were reviewed.Potential adverse events include 'complications associated with standard catheterization and use of angiography include, but are not limited to, injury including perforation or dissection of vessels, thrombosis and/or plaque dislodgement which may result in emboli formation, distal vessel obstruction, hemorrhage, infection, and/or death'.No ifu/training deficiencies were identified.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.The complaints for sheath kinked, bent, inability to advance through sheath, and liner punctured were confirmed based on the provided imagery.However, the complaint for sheath distal tip torn was unable to be confirmed as no device/relevant imagery were provided.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.A review of the ifu/training materials revealed no deficiencies.Furthermore, no abnormalities were reported during device unpacking or preparation.As reported, 'during implant of a 26mm sapien 3 ultra resilia valve in the aortic position, when pushing the 26mm resilia valve through the sheath the team encountered resistance.Fluoro then panned down to valve in sheath showing that the sheath was bent by the implanting physician due to reaching across the patient's body.The team then tried to push the valve with the sheath straight and still encountered push forces and was unable to advance the valve.The team used propafol and the valve was able to advance through the sheath but under fluoro it appeared the sheath split and the valve separated from the catheter with the valve appearing on the outside of the sheath.' per imagery review, the associated valve exited the sheath through the liner puncture.Per the training manual, 'push force can vary due to angle of access and insertion, vessel diameter, tortuosity, and degree of calcification.' tortuosity can create sub-optimal angles for sheath insertion, requiring a high push force to navigate.Calcification and undersized vessels can create a restricted pathway or constrained condition and further contribute to resistance.However, no patient information was provided.If excessive manipulation was used to overcome resistance, it may lead to sheath kinks.A kink would prevent the delivery system from advancing through the sheath.Excessive manipulation may also cause the valve to catch on to the liner during delivery system advancement.If high push force was used to overcome the difficulty during delivery system advancement, the valve may tear the liner, resulting in the observed liner puncture.As such, available information suggests that procedural factors (excessive manipulation, high push force, valve caught on liner, kinked sheath) may have contributed to the complaint event.As reported, 'the team was unable to advance the valve past the distal tip of the sheath.By slowly inflating the balloon, the distal tip of the sheath was torn, however the team was able to pull back the sheath and deploy the valve in the abdominal aorta.' as the balloon was inflated while inside the sheath, this likely caused the reported distal tip tear.However, as the device was not returned, the nature of the tear could not be confirmed.As such, available information suggests that use error (balloon inflation within sheath) may have contributed to the complaint event.Since no device problem was identified affecting distributed product, no pra or capas are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.Since no edwards defects were identified, no corrective or preventative actions are required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS ESHEATH PLUS INTRODUCER SHEATH
• 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: 16991783
• MDR Text Key: 315833078
• Report Number: 2015691-2023-13197
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)250226(11)2302272164907602
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Catalogue Number: 914ESPA
• Device Lot Number: 64907602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male