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

Model Number 914ESA

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported, during a transfemoral tavr procedure with a 23 mm sapien 3 valve with percutaneous access, valve insertion into the esheath required greater force than usual due to smaller vessel diameter.Per medical opinion, this resulted in a dissection of the left common femoral and left external iliac artery.Attempts for percutaneous repair were unsuccessful. a cut down was performed for surgical repair.Per report, there was no abnormalities noted with the sheath, the loader was able to be fully inserted into the sheath, and the sheath was not inserted at a steep angle.  the resistance was felt when the crimped valve crossed into the partially expandable portion of the sheath.

Manufacturer Narrative

According to the ifu, cardiovascular complications, including perforation or dissection of vessels which may require intervention, are potential adverse events associated with the transfemoral transcatheter aortic valve replacement procedure.The sheath was not returned to edwards lifesciences for evaluation.  in addition, no imagery was provided by the site.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.During manufacturing, 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.  during visual inspection and final inspection, the sheath was inspected for any defects or abnormalities.  these inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint event.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was performed and revealed no additional similar complaints for sheath shaft resistance with delivery system.  a review of the complaint history revealed that the complaint occurrence rate did not exceed the october 2019 control limit for the trend category.A review of the instruction for use (ifu) and training manuals for revealed no deficiencies.  per the ifu: during insertion; orient the delivery system with the flush port pointing away and the edwards logo facing up; ensure delivery system is locked in default position; insertion force through the partially expandable portion can be higher than the push force through the fully expandable portion; push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification; if push force is high, consider slightly pulling back the sheath while advancing the thv/delivery system 1.2 cm; in expectation of high friction, use short movements.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 complaint of sheath shaft resistance with delivery system was unable to be confirmed.A review of lot history, dhr, and manufacturing mitigations revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.Per reported event, ¿valve insertion into the esheath required greater force due to smaller vessel diameter which resulted in a dissection of the left common femoral and left external iliac artery.¿ there is insufficient information to determine a definite root cause.However, the following factors can result in the observed resistance: access vessel tortuosity/calcification/vessel size calcification can prevent the sheath from fully expanding and tortuosity can introduce difficult bend angles in the delivery system insertion pathway.The minimum vessel diameter for 14f esheath is 5.5mm.Smaller vessels could constrict the transient expansion of the esheath resulting in difficulties.The patient¿s vessels were reported as ¿fragile, straight, and on the smaller side¿.However, without imagery, these access vessel characteristics could not be evaluated.Improper sheath orientation per training materials, sheath should be inserted with the edwards logo facing upward so the seam remains down to ensure proper sheath performance.Improper flushing of sheath not properly flushing sheath can result in increased resistance between the delivery system/thv and sheath.In this case, there was no malfunction of the sheath, delivery system, or valve but the patient¿s smaller access vessels and the greater force required while inserting the valve may have resulted in the vascular injury.  since no manufacturing non-conformances or ifu/training deficiencies were identified, no corrective/preventative actions, nor a product risk assessment is 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: 9273556
• MDR Text Key: 165570059
• Report Number: 2015691-2019-04095
• 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: 10/10/2019

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: 04/01/2021
• Device Model Number: 914ESA
• Device Lot Number: 62132596
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 07/23/2020
• Supplement Dates FDA Received: 12/10/2019; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention