MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610ES16

Device Problems Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As found through pre-decontamination evaluation, the sheath distal tip was split.As reported by our affiliates in australia, 26mm sapien 3 case by transseptal approach through the femoral vein in mitral position inside a pre-existing 29mm non-edwards mitral prosthesis (viv) was performed. it was attempted to align the valve inside the esheath but there were issues with the fine alignment and valve alignment could not be completed.All devices were removed and for the second attempt, a 16fr esheath was used.This time during valve alignment, it was seen that the pusher was moving and again they were unable to align the valve.The delivery system with valve was removed.A third attempt was done with a new 16fr esheath and this time was successful, and the valve was deployed.  there were no withdrawal difficulties with any of the devices, both devices were removed within the esheath and did not require surgical intervention.

Manufacturer Narrative

The sheath was returned with inserted delivery system for evaluation.  a crimped thv was located in the sheath and on the delivery system inflation balloon.  a review of procedural imagery showed tension in the delivery system during valve alignment.  visual inspection of the returned device showed the following:  sheath distal tip is confirmed split; light scratches were observed on the sheath shaft near the sheath distal tip; damage observed on the soft tip.Due to the nature of the complaint, there was no applicable dimensional inspection or functional testing.During manufacturing, the sheath shaft components were 100% visually inspected for any defects.  during the manufacturing process the esheath final assemblies were 100% visually inspected by both manufacturing and quality.  the inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.A review of complaint history from (b)(6) 2019 to (b)(6) 2020 revealed additional similar returned complaints for the esheath introducer sheath (all models and sizes) for distal tip spilt.  the complaints were confirmed, but no manufacturing non-conformances were identified.Available information suggested that patient and/or procedural factors may have contributed to the events.A review of the risk management documentation was performed and 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 distal tip - split was confirmed based on visual inspection of the returned device.Investigation of the device and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.The presence of calcification in the access vessel can be supported by scratches on the sheath shaft observed during visual inspection.It is also possible that the calcification came in contact with the tip and damaging the soft tip and splitting the hdpe material.As such, available information suggests that patient factors (access vessel calcification) may have contributed to the complaint event.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation and a corrective/preventative actions are not required.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10169599
• MDR Text Key: 196556376
• Report Number: 2015691-2020-12201
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 08/28/2020; 07/23/2020
• Supplement Dates FDA Received: 08/31/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR