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

Model Number 914ESPA

Device Problem Material Integrity Problem (2978)

Patient Problem Vascular Dissection (3160)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-12136 for the delivery system.Investigation is ongoing.Device not returned.

Event Description

As reported by the field clinical specialist, the delivery system balloon ruptured as the valve was being deployed due to a calcified stj.The valve was deployed successfully, however the balloon rupture led to withdrawal difficulty when it was retracted into the sheath.This caused the sheath to split and the entire system was removed as a unit.Following removal of the devices, it was reported that the split sheath caused the vessel to become damaged and subsequent intervention was needed in order to repair the vessel.A stent was placed bilaterally.Additional information received noted that the balloon was fully inflated.There was moderate calcification in the patient's landing zone.During withdrawal the physician encountered a high degree of resistance when trying to extract the delivery system.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information from the completed product investigation.The following section of this report has been updated: update to b4, g3, g6, h2, h6, h10.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.Imagery was provided and the following was observed: sheath shaft was severely bent.Sheath distal tip is unable to be assessed due to the quality of the image.Undersized vessels ('6.0mm required for use of 16f esheath+).Calcification present in the patient's access vessels.Tortuosity present in the patient's access vessels.Review of the work orders above did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review was performed using the valve serial numbers from related work order and revealed no other complaints relating to the relevant complaint codes.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 commander and esheath+ ifu's were reviewed as well as the device preparation and procedural training manual.Precautions note that 'caution should be used in vessels that have diameters less than 5.5 mm or 6 mm as it may preclude safe placement of the 14f and 16f edwards esheath+ introducer set respectively'.Potential adverse events discuss that '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.' instructions on mounting and crimping the valve on the delivery system, valve delivery, system removal, device preparation, sheath removal, and balloon bursts are all provided in the training manuals.No ifu/training deficiencies were identified.The complaint for sheath distal tip damage was unable to be confirmed as no relevant imagery/device was returned, while the complaint for sheath kinked, bent was confirmed based on the provided imagery.A review of the dhr, lot history, and complaint 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, 'the delivery system balloon ruptured as the valve was being deployed due to a calcified stj.The valve was deployed without a problem, however the balloon rupture caused a problem when it was retracted into the sheath.The balloon rupture caused the sheath to split and the entire system had to be removed as a unit.' per imagery review, the sheath shaft was severely bent; however, no clear images of the distal tip were provided (figure 1).Per imagery review, undersized vessels, calcification, and tortuosity were present in the patient's access vessels (figures 2-4).It is likely that the altered balloon profile interacted with the sheath distal tip and sheath shaft, causing the reported damages during delivery system withdrawal.It is also possible that the presence of tortuosity and calcification may cause non-coaxial alignment between the devices during withdrawal and further contribute to the friction on the distal tip and sheath shaft, which can lead to the shaft to bend and the tip to become damaged.Undersized vessels may also create a restricted pathway, increasing friction on the distal tip and sheath shaft during delivery system withdrawal.It is also possible that excessive manipulation was used in order to overcome the withdrawal difficulty of the burst balloon, resulting in the sheath kink.As such, available information suggests that patient factors (calcification, tortuosity, vessel size) and/or procedural factors (withdrawal of burst balloon, excessive manipulation) may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is 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: 16691507
• MDR Text Key: 312801815
• Report Number: 2015691-2023-12141
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)241120(11)2211212164726673
• 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: 05/11/2023

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: 914ESPA
• Device Lot Number: 64726673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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 Age: 75 YR
• Patient Sex: Male