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

Model Number 914ESA

Device Problem Physical Resistance (2578)

Patient Problem Perforation of Vessels (2135)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

Thv/tvt registry.The investigation is ongoing.

Event Description

During implant of a 23mm sapien 3 valve in the aortic position via transfemoral approach, there was difficulty advancing the valve and delivery system through the esheath.The delivery system, valve and 14fr esheath were removed.A 16fr esheath was then inserted into the patient and a new valve was delivered.The external iliac was noted to be perforated and a covered stent was deployed in the common femoral.The resistance advancing the valve and delivery system through the esheath was felt before the seam of the sheath was able to split.No abnormalities were noted with the sheath, the loader was able to be fully inserted into the sheath/sheath housing, and the esheath was not inserted at a steep angle.The patient¿s access vessel minimum luminal diameter was 6mm, was moderately calcified and mild-moderately tortuous.

Manufacturer Narrative

The devices were not returned to edwards lifesciences for evaluation.Therefore, visual, dimensional, and functional testing could not be performed.Per the report, there was resistance while advancing the delivery system through the esheath, before the esheath was able to expand.Per the training manual, ¿push force can vary due to angle of insertion, thv size, vessel diameter, tortuosity and degree of calcification¿.It was reported that the patient¿s access vessel had moderate calcification.This likely impacted the insertion of the delivery system through the sheath as the calcified vessels create a difficult pathway for insertion.Additionally, it was noted that the patient¿s access vessel had mild to moderate tortuosity.Vessel tortuosity could change the position of the sheath, affecting the angle of insertion of the delivery system, thus resulting in higher push forces.The presence of calcification in the access vessel would further prevent the sheath liner from expanding properly.Although a definitive root cause could not be determined, available information suggests that patient factors (tortuosity/calcification) may have contributed to the reported event.During manufacturing, the esheath shaft components are 100% inspected.The sheath is also visually inspected for any defects.The esheath tip was 100% inspected under 8-20x magnification, and tears and id scratches in the liner expansion pathway under 10x magnification.During the final inspection, the esheath component was 100% dimensionally inspected.After sterilization, sheath expansion testing was performed during product verification (pv) on finished devices from the work order under a sampling basis.The devices undergo visual inspection and expander insertion force test.During the manufacturing of the commander delivery system, the flex tip outer diameter is 100% inspected to ensure correct size is used as it is the largest component that pass through the sheath.The delivery system also undergoes 100% manufacturing and quality inspection for the following: inspect entire device: reject for missing components, incorrect assembly and device damage.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.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.According to the instructions for use (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.Investigation results suggest/indicate device manipulation and patient factors (moderately calcified and mild-moderately tortuous access vessels) may have been contributing factors for the iliac artery perforation.Due to the device and photos not being returned for evaluation, the complaints ¿sheath shaft ¿ resistance with delivery system, bc¿ was unable to be confirmed.A review of the complaint history and manufacturing mitigations did not reveal any indications that a manufacturing non-conformance of the esheath was the source of the complaint.In this case, the cause of the sheath shaft resistance and subsequent iliac perforation is unknown.However, per engineering evaluation, may be due to device manipulation and patient factors (moderately calcified and mild-moderately tortuous access vessels).No labeling/ifu inadequacies were identified.Review of complaint history revealed that the occurrence rate does not exceed control limits for this trend category.Therefore, no corrective or preventative action 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: 7630624
• MDR Text Key: 112066191
• Report Number: 2015691-2018-02414
• 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
• Report Date: 05/31/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 914ESA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/25/2018; 07/23/2020
• Supplement Dates FDA Received: 08/03/2018; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention