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

Model Number 914ESPA

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress, a supplemental report will be submitted.H3 other text : device not available.

Event Description

Edwards received notification from a field clinical specialist that during a transfemoral tavr, the operator dilated the right femoral with 16f dilator.The first 14f esheath+ was attempted but was unable to be advanced.No calcification noted at the puncture site.The patient had a deep tissue track.There was no damage, malfunction, or patient injury associated with the 1st esheath.It was decided to prep and used another 14f esheath+ and advanced with no problems.When advancing the commander, the operator met resistance in the expandable portion of the sheath.The operator was able to continue to advance valve.When the sheath was removed at the end of the procedure, a hole was noted in the expandable portion.The perceived root cause was a steep access angle causing the valve to have trouble advancing.A manta was attempted and deployed in the wrong place.A surgeon was then performed a cut down to repair access site.The patient received blood products during repair.A leak was reported when the sheath was flushed indicating a liner tear.Per photos provided, there was strain relief damage noted.

Manufacturer Narrative

The device was not available to be returned for evaluation.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.The complaints resistance between system components, sheath strain relief damage, and sheath liner torn were confirmed through review of provided imagery.An existing edwards' technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in the technical summary were reviewed and the following were identified as applicable to this event: 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.As per review of the provided imagery, 3mensio showed presence of tortuosity in both access vessels.The provided post-procedural device photo showed curvature of the sheath shaft and a kink, suggesting presence of tortuosity.A steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.As reported, ''the perceived root cause was a steep access angle causing the valve to have trouble advancing.'' the presence of the above factors can create 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.It is possible that additional device manipulation to overcome the resistance may be applied during the procedure resulting in damage to the sheath.During delivery system advancement through a challenging pathway, it is possible that the devices may not be coaxially aligned.This can lead to the crimped valve to catch onto the sheath hdpe, liner, and/or strain relief and lead to damage.Furthermore, tortuosity can subject the sheath to suboptimal angles that can lead to shaft kinks.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with this issue.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.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.As such, available information suggests that patient factors (tortuosity) and/or procedural factors (steep insertion angle, valve caught on liner /sheath, excessive manipulation) may have contributed to the reported event.However, a definitive root cause is unable to be determined at this time.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: 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: 16841403
• MDR Text Key: 314268440
• Report Number: 2015691-2023-12674
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)241116(11)2211172164706712
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Device Lot Number: 64706712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/30/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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): Required Intervention
• Patient Sex: Male