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

Model Number 914ESPJ

Device Problem Difficult to Advance (2920)

Patient Problem Perforation of Vessels (2135)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.H3 other text : device discarded.

Event Description

As reported through the japanese tavi registry, during a tavr procedure using a 20mm sapien 3 ultra resilia valve was transfemorally deployed in the aortic annulus via right leg access.Bleeding and a rupture of the external iliac artery (eia) were reported.The cause of the eia rupture may have been due to forcibly advancing the delivery system.After inserting the 14 fr esheath+, there seemed to be considerable resistance when advancing the delivery system.There was no damage reported to the esheath.A stent graft was implanted for the eia rupture.The outcome was determined as recovering.The device was discarded at the hospital.

Manufacturer Narrative

The 14 fr esheath plus was not returned for examination.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Imagery was received that showed calcification, tortuosity, and undersized vessel diameter are present in the access vessel.As reported through the japanese tavi registry, during a tavr procedure using a 20mm sapien 3 ultra resilia valve was transfemorally deployed in the aortic annulus via right leg access.Bleeding and a rupture of the external iliac artery (eia) were reported.The cause of the eia rupture may have been due to the forced advancing of the delivery system.After inserting the 14 fr esheath+, there seemed to be considerable resistance when advancing the delivery system.There was no damage reported to the esheath.A stent graft was implanted for the eia rupture.The outcome was determined as recovering.The device was discarded at the hospital.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.The complaint for resistance issues was unable to be confirmed due to no relevant imagery/device provided.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with the delivery system and valve frame damage as a result of increased push force.Tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Per a review of the provided imagery, tortuosity was present within the access vessel.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Per review of the provided imagery, calcification was present within the access vessel.Undersized vessels (e.G.Due to anatomical variation, pre-existing stent or graft, scar tissue, or fibrosis) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion and increased resistance during the advancement of the delivery system.Per review of the provided imagery, undersized vessel regions were present within the access vessel.The presence of the above factors can create a challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or non-conformance associated with this issue.There are several 100% in-process inspections (visual) performed in the 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.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.In this case, available information suggests that patient factors (calcification, tortuosity, undersized access vessels) 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.This event was previously captured in a product risk assessment.

• 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: 18067937
• MDR Text Key: 327318360
• Report Number: 2015691-2023-17265
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103217360
• UDI-Public: (01)00690103217360(17)250531(10)65207785
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPJ
• Device Lot Number: 65207785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female