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

Model Number 916ESA

Device Problems Peeled/Delaminated (1454); Off-Label Use (1494); Material Separation (1562); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problems Calcium Deposits/Calcification (1758); Scar Tissue (2060); No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation is ongoing.

Event Description

As reported, during an off-label the tf tricuspid valve in valve case (within a pre-existing 29mm.St.Jude epic valve) via right venous access, the vein was ¿fraught with scar tissue¿.When attempting to advance the s3 valve and commander delivery system through the esheath, they were met with resistance in the vessel.Several attempts were made to advance the system but were unsuccessful.Attempts at pulling the sheath, valve, and delivery system back together and advancing together were also unsuccessful.At this point it was noted on fluoro that these attempts had kinked the balloon shaft in two places.The valve and delivery system were successfully withdrawn into the sheath and removed together.The rfv was closed and new tf access was achieved via the lfv with successful insertion of the esheath.A new s3 valve and commander delivery system were inserted into the esheath without any issues and valve alignment was successfully completed.  upon examination of the devices on the prep table after removal from the rfv, it was noted that approximately 1/2 of the distal end of the esheath liner had delaminated.The operators had already pulled the commander out of the sheath to closely examine the sheath.Per the physician, it is believed that scar tissue in the vessel, calcium in the vessel, and/or the angle at which the s3 valve and commander delivery system were tracking into the patient (very deep approach) may have contributed to the events.

Manufacturer Narrative

The esheath was returned for evaluation with the introducer fully inserted.Multiple kinks were observed on the sheath shaft.Circumferential liner delamination 6 inches in length from the distal tip occurred, but the marker band remained intact.Due to the nature of the complaint, function and dimensional testing were not performed.During manufacturing of the esheath introducer set, the sheath and components are 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 dhr review was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed one other complaint relating to resistance, but no other complaints relating to the other codes.A review of the complaint history from (b)(6) 2018 to (b)(6) 2019 for edwards esheath revealed other returned similar complaints.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.The occurrence rate did not exceed the (b)(6) 2019 control limits for the complaints.Therefore, a complaint history review is not required.Photographs of the complaint sheath were provided by the procedural site.A kink was noted at the proximal strain relief near the comnut.Circumferential liner delamination was observed approximately halfway of the sheath length from the distal tip.Also, multiple kinks were observed on the sheath shaft where the liner delaminated.Note: the device was used in an off-label implantation in the tricuspid position with a sapien 3 valve.As there are no specific ifu or training materials related to sapien 3 with tricuspid procedures, the available training materials were reviewed only for information potentially relevant to the device use.A review of the ifu, esheath preparation training manual, and commander procedural training manual was performed for instructions/guidance on device preparation and usage.The user advised that push force can vary due to the angle of insertion, vessel diameter, tortuosity, and degree of calcification.The sheath should not be forced.The physician should avoid using the sheath with tortuous or calcified vessels that would prevent safe entry of the introducer sheath.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.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 regarding the liner delamination and kink were confirmed by visual inspection of the returned device, but the complaint regarding resistance experienced with the delivery system was unable to be confirmed as no applicable procedural cine/imagery was provided.However, no manufacturing non-conformances were identified during the investigation.Based on a review of the dhr, lot history, and complaint history, there was no indication that a manufacturing nonconformance contributed to the reported event.A review of manufacturing mitigations supports that the sheath shaft has proper inspections in place to detect issues related to the reported event.Additionally, a review of the ifu and training manual revealed no deficiencies.There was no note of abnormalities on the sheath during device preparation, suggesting that there was no issue with the device when removed from packaging.Per training manual, ¿push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification.¿ calcification was reportedly present in the access vessel which could prevent sheath from fully expanding to allow for the ds insertion/advancement.Scar tissue in the vessel could have compounded with presence of calcification and further exacerbated the insertion difficulty.Steep insertion angle can contribute to the increased push force.All the above factors can be supported by the complaint description, ¿per the physician, it is believed that scar tissue in the vessel, calcium in the vessel, and/or the angle at which the s3 valve and commander delivery system were tracking into the patient (very deep approach)¿.As the resistance was met, excessive force was likely used to counter it which resulted in sheath kinking and liner delamination.As such, available information suggests that patient (calcification/scar tissue) and/or procedural factors (steep insertion angle/excessive device manipulation) may have contributed to the reported events.Since no defect was confirmed, no corrective or preventative actions are required.Additionally, since no product non-conformance or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.

Manufacturer Narrative

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

• Brand Name: EDWARDS ESHEATH INTRODUCER SHEATH
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9121141
• MDR Text Key: 196559087
• Report Number: 2015691-2019-03572
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 916ESA
• Device Lot Number: 62467201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR