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

Model Number 9610ES16

Device Problems Material Perforation (2205); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem Rupture (2208)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during a transfemoral tavr procedure, after successful implantation of a 29mm sapien 3 valve, at the time of retrieving the esheath, it appeared that the esheath liner perforated.It was suspected that the liner tore just before removal.The patient sustained a femoral artery rupture.It was not possible to close the artery with the closure system; therefore, a balloon was inserted to control the bleeding and the artery was surgically closed.The patient was reported to be doing well post procedure.

Manufacturer Narrative

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

Manufacturer Narrative

Section d10, h6 and h10.Section h10: additional information provided indicated the patient was accessed through the right femoral artery.Tortuosity and calcification of the access vessel was not identified as potentially difficult during the ct image review performed both prior and after the case.The esheath was returned to edwards lifesciences for evaluation.The device underwent visual and dimensional testing.During visual inspection, the sheath liner was observed to be fully expanded.A minor dent was found in the body of the sheath approximately 70mm from the distal tip.A kink was found in the body of the sheath approximately 50mm from the strain relief.The tip was observed to have no damage.The liner had a tear along the body of sheath.During dimensional testing, the liner thickness was measured along the length of the tear.Thicknesses deviating from the specification could contribute to liner tear and/or be indicative of a manufacturing non-conformance.Measurements were obtained on one side of the liner due to the location of the liner tear.The liner thickness was found to be within specification at all measured locations.Due to the nature of the complaints, no functional testing was able to be performed.Procedural videos, imagery and photographs were provided by the site for review.The following was observed: the nose cone along with the guidewire was revealed to be outside of the sheath indicating that the sheath liner was torn.The sheath liner was torn along the expandable portion¿s entire length.During manufacturing of the esheath, the sheath shaft components were inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A device history records (dhr) review was performed and did not reveal any manufacturing non-conformance that would have contributed to this complaint event.Review of the lot history did not reveal any similar complaints.A review of complaint history from june 2019 through may 2020 revealed additional returned complaints for the esheath (all models and sizes) for the failure modes.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.No confirmed manufacturing nonconformances were identified in the returned devices.A review of complaint histories revealed that the monthly occurrence rates did not exceed the may 2020 control limits for the trending categories.The esheath instructions for use (ifu), the device preparation training manual, and the device procedural training manual were reviewed for instructions involving device preparation and procedures relating to the complaint event.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are anticipated risks of the transcatheter heart valve procedure.Additional assessments of the failure modes are not required at this time.The complaints were confirmed through the device photos provided and evaluation of the returned sample.No manufacturing abnormalities were observed on the returned sample; dimensional measurements met specification.A review of manufacturing mitigation 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.Reviews of dhr, lot history, and complaint history showed no indication of a manufacturing non-conformance contributed to the event.Per the case notes, it was noted that valve alignment was performed partially inside the sheath.This would have enlarged the profile and increased the interaction between the crimped valve and the liner.While this may not cause immediate damage to the sheath liner, the liner could have been stretched/weakened and more susceptible to damage during device retrieval.Review of complaint history revealed that patient access vessel tortuosity (if present) can create sub-optimal angles during the retrieval of the delivery system.This can potentially lead to the delivery system catching onto the liner of the sheath and creating a liner tear upon withdrawal.Similarly, if the delivery system is not fully unflexed (non-coaxial withdrawal) and/or the balloon is not fully deflated (enlarged profile) prior to withdrawal, it can result into the same failure.In both cases, it would increase the chances of the device being caught on the sheath distal tip during removal and lead to the tearing of the liner.However, there was no reported device insertion or withdrawal difficulty in this case.Product evaluation also shows no damage to the distal tip of sheath, indicating that the device was not being caught to the sheath tip during removal.In addition, based on the provided patient information, nothing seems to be out of the ordinary that would have contributed to the line tear.There was insufficient information to determine a root cause at this time.Per sample evaluation, a kink was noted about 50mm from the strain relief.The liner being torn would lead to decreased shaft column strength, which would make the sheath more susceptible to kinking during device withdrawal.As such, procedural factors (device withdrawal through sheath with a torn liner) may have contributed to the reported event; however, a definitive root cause was unable to be determined.The occurrence rates did not exceed the may 2020 control limits for the trend categories, therefore no corrective or preventative actions, nor a product risk assessment (pra) was required.

• Brand Name: EDWARDS EXPANABLE SHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10118988
• MDR Text Key: 194109929
• Report Number: 2015691-2020-12053
• 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: 05/15/2020

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 Expiration Date: 02/17/2022
• Device Model Number: 9610ES16
• Device Lot Number: 62988360
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 07/15/2020; 07/23/2020
• Supplement Dates FDA Received: 07/24/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention