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

Model Number 916ESJ

Device Problems Material Separation (1562); Failure to Align (2522); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our affiliate in (b)(6), prior to the transfemoral tavr procedure, severe access vessel tortuosity was noted.The access vessel was extended with a wire inserted from the contralateral side.Following insertion of the 16fr.Esheath, difficulties were encountered during valve alignment.An attempt was made to withdrawal the commander delivery system back into the esheath, however, the 29mm sapien 3 valve got stuck at the sheath tip.Negative pressure was applied, and valve alignment was ¿forcibly¿ performed.The sapien 3 valve was successfully deployed at the targeted position.During withdrawal, the delivery system could not be pulled back into the sheath.Negative pressure was applied to the balloon as much as possible and the delivery system and sheath were removed together.Digital subtraction angiography (dsa) showed no vessel injury, and the incision site was closed with the perclose.Upon removal, delamination of the esheath liner was observed.No injuries to the patient were reported.At the time of the report, the patient was doing well.The access vessel minimum luminal diameter measured 6.2mm x 6.9mm with severe tortuosity reported.A stent graft was present in the abdominal aorta.The esheath and delivery system will be returned for evaluation.The valve remains implanted in the patient.

Manufacturer Narrative

Additional information: evaluation codes; narrative text.The esheath was returned to edwards lifesciences for evaluation.Visual inspection of the returned sheath revealed the circumferential delamination of the sheath liner approximately 1.5 inches in length.The liner was observed to be bunched and the sheath tip was spilt.A kink and damage to the hdpe along the delamination length was observed.Deep scratches were noted 5 inches in length 2.5 inches from the distal tip.The marker band was attached, and the liner was expanded normally.The review of the provided patient imagery revealed tortuosity present in the access vessels and confirmed the vessel diameter size.Review of the post-procedure photographs of the sheath revealed sheath delamination.Due to the nature of the complaint and the condition of the returned sheath (sheath distal tip liner delamination, split) functional testing and dimensional analysis could not be performed.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformance that could have contributed to the reported event.Lot history review revealed no additional complaints for the two reported events.Complaint history review from (b)(6) 2018 to (b)(6) 2019 for the esheath introducer set (all models and sizes) revealed similar reported events for the first event.No manufacturing non-conformance were identified during the evaluations.Available information suggested procedural / patient factors may have contributed to the reported events.Complaint history review revealed similar reported events for the second event.No manufacturing non-conformance were identified during the evaluations.Available information suggested procedural / patient factors may have contributed to the reported events.A review of complaint history revealed that the occurrence rates did not exceed the (b)(6) 2019 control limits for the appropriate trend categories.The ifu and training manuals have been reviewed and no inadequacies were identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.During the manufacturing process, the sheath shaft components undergo multiple 100% visual inspection under magnification.The esheath final assembly undergoes multiple 100% visual inspections by both manufacturing and quality.Additionally, after sterilization, the sheath was tested and inspected on a sampling basis during product verification (pv) testing.All samples passed pv testing.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.In this case, the complaints were confirmed based on the condition of the returned device.However, no manufacturing non-conformance were identified.Per imagery provided patients vessels were heavily tortuous.It is likely that the tortuosity created a difficult pathway for the delivery system.The complaint description states ¿while retrieving the device, the system could not be pulled into the sheath due to deformation of the sheath tip which possibly stemmed from the forcible valve alignment¿.Also stated in the complaint was ¿since a sapien 3 valve got stuck at the sheath tip, negative pressure was applied and then valve alignment was forcibly done by placing the valve over the sheath tip¿.Improperly performing valve alignment (using sheath tip to align thv on balloon), and also applying force to withdraw the delivery system could have contributed to the reported events.Available information suggests patient factors (access vessel tortuosity), in addition to procedural factors (excessive device manipulation) likely contributed to both the liner delamination and distal tip split.Since no product non-conformance or ifu/training manual deficiencies were identified and review of complaint history revealed that the complaint rate did not exceed the (b)(6) 2019 control limit for the relevant trend categories, no corrective or preventative actions are required at this time.

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: 9079752
• MDR Text Key: 194027080
• Report Number: 2015691-2019-03468
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2019

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: 04/03/2021
• Device Model Number: 916ESJ
• Device Lot Number: 62132593
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 07/23/2020
• Supplement Dates FDA Received: 11/27/2019; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 67