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

Model Number 914ESA

Device Problems Material Rupture (1546); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problems Death (1802); Injury (2348); Blood Loss (2597)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This is one of two manufacturer reports being submitted for this case. please reference related manufacturer report no: 2015691-2019-0225.Investigation is ongoing.

Event Description

During the valve alignment of the sapien 3 onto the commander delivery system via left subclavian axillary access, there was difficulty with valve alignment.It was attempted to align the valve in the esheath, as it was the straightest section.However, it could not be completed in the esheath, so the valve was pushed outside of the sheath, but could not be completely aligned.The team decided to deploy with the valve 80% aligned onto the balloon.However, the balloon would not inflate.It is believed it "ruptured" during the difficulty with valve alignment.During retrieval of the valve into the sheath, it was seen that the esheath seam had ¿torn¿, but the valve and delivery system were able to be pulled into the sheath.It was seen that the pusher was not all the away against the valve, so it had to be re-advanced, then pulled it.There was not much difficulty pulling the delivery system into the sheath.During removal, the esheath ¿pulled the artery out¿.The balloon was kept in the subclavian artery to block the blood loss, as the patient had loss ¿2 liters¿ already.Due to the injury at the access site, the patient was converted to surgery and a covered stent was placed in the proximal subclavian artery.  unfortunately, there was too much blood loss and the patient passed away.

Manufacturer Narrative

Update to g4 and h10.Engineering review of the received image provides evidence of liner delamination from the sheath shaft.  the liner does not appear to be torn based on the image.Investigation is ongoing.

Manufacturer Narrative

Udi: (b)(4).The device was not returned for evaluation as it was discarded by the site.A photograph was provided with the complaint, the photograph confirms the complaint for liner delamination.A lot history review was performed and revealed no other similar complaints.The device history review (dhr) did not reveal any manufacturing related issues that would have contributed to this complaint.A review of complaint history for the edwards esheath introducer set (all models and sizes) for the past 12 months (b)(6) 2018 to (b)(6) 2019) revealed other similar complaints , but no manufacturing non-conformances were found in the returned samples.Available information suggested that patient and/or procedural factors may have contributed to the events.A review of complaint history data for june 2019 revealed that the complaint occurrence rate did not exceed the control limit for the trend category.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.The esheath ifu, commander delivery system, procedural training manual, and training supplement for subclavian access reviewed for instructions/guidance for preparation and use of the devices.Based on the review of the ifu/training manuals, no deficiencies were identified.The complaint was confirmed using a photograph that was provided with the complaint.Due to unavailability of device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed. no potential manufacturing non-conformances were identified.A review of manufacturing mitigations supported that the sheath has proper inspections in place to detect issues related to the reported event.Based on the applicable complaint history, dhr and lot history review, there is no evidence to support a manufacturing non-conformance contributed to the complaint.The report states that retrieval of an undeployed valve was attempted.During the attempt, it was seen that the pusher was not against the valve.This would have exposed the proximal edge of the valve to the sheath tip, and the valve may have caught on the tip during withdrawal.Applying further force at this time may have caused the sheath liner to delaminate.Additional factors that could contribute to the liner delamination include altered balloon profile (a balloon leak was detected upon inflation) and non-coaxial alignment of the delivery system and sheath during withdrawal.It is likely that procedural factors (retrieval of undeployed valve) contributed to the complaint event.Review of complaint history revealed that the occurrence rate did not exceed the may control limits.Since no manufacturing non-conformances, labeling, training, or ifu deficiencies were identified, no corrective and preventative action is required at this time.

Manufacturer Narrative

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

• Brand Name: EDWARDS EXPANDABLE INTRODUCER SHEATH SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8720404
• MDR Text Key: 148758662
• Report Number: 2015691-2019-02260
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/29/2019

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 Expiration Date: 12/05/2020
• Device Model Number: 914ESA
• Device Lot Number: 61772831
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 07/31/2019; 07/23/2020
• Supplement Dates FDA Received: 07/16/2019; 07/31/2019; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR