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

Model Number 914ESPA

Device Problem Material Frayed (1262)

Patient Problem Perforation of Vessels (2135)

Event Date 10/02/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.Device expected back.

Event Description

As reported, during a procedure to implant a 26mm sapien 3 ultra, it looked like calcium had scraped the sheath seam as the seam had peeled back and created rough edges along the sheath shaft (sheath scoring).This led to arterial perforation at access site requiring vascular surgery to repair.The patient was reported to be stable.

Manufacturer Narrative

The sheath was returned and visually inspected; the liner was fully expanded, and tip opened as designed.The hdpe was slightly damaged on the side of the liner about 4inches from the strain relief.Imagery was provided from the site and revealed the following: hdpe damage on sheath shaft.Due to the nature of the complaint no applicable functional testing or dimensional testing was performed.A device history record (dhr) review was done and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to the complaint failure sheath damaged.A complaint history review on confirmed device complaints for failure sheath damaged identified patient factors, calcification and procedural factors excessive manipulation as a potential root cause applicable to the event.The instructions for use (ifu) for esheath+ ifu, s3u, commander, esheath+ preparation manual and s3u, commander, esheath+ procedural manual.No ifu/training deficiencies were identified.A risk assessment was performed on the reported event and revealed no evidence of product non conformances or labeling/ifu inadequacies.The complaint for failure sheath damaged was confirmed through evaluation of the returned device/imagery.Reviews of the dhr, lot history, and complaint history did not provide any indication that a manufacturing nonconformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issue with the sheath during device unpacking or preparation.Per the complaint description, the seam had peeled back and created rough edges along the sheath shaft.Looked like calcium had scraped the seam of the sheath.Evaluations of the returned device and procedural imagery show that the sheath shaft was damaged along the seam.Per the training manual, access characteristics that would preclude safe placement of the sheath such obstructive calcification, severe tortuosity or vessel diameter less than the minimum recommended should be carefully assessed prior to the procedure.Calcification can reduce the vessel lumen diameter and create added friction on the outer shaft.Sharp nodules of calcium can also interact with the sheath shaft, causing hdpe damage.It is likely that excessive manipulation was also used, given the nature of the damage seen.Excessive manipulation was likely used to overcome any resistance and caused sharp nodules of calcium to interact with the sheath causing the hdpe damage.As such, available information suggests that patient factors (calcification) and/or procedural factors (excessive manipulation) may have contributed to the reported event.Since no product nonconformances or ifu/training deficiencies were identified during evaluation, a product risk assessment (pra) is not required.Since no manufacturing defects were confirmed no corrective and preventative actions (capa)are required.In this case, a vascular perforation occurred and was possibly due to procedural factors (device manipulation) and/or patient factors calcification of the access vessel that may have contributed to the complaint event.

• Brand Name: EDWARDS ESHEATH PLUS
• 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: 15666413
• MDR Text Key: 302342165
• Report Number: 2015691-2022-08800
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240517(11)2205182164381124
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 914ESPA
• Device Lot Number: 64381124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2022
• 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