MAUDE Adverse Event Report: EDWARDS LIFESCIENCES ESHEATH PLUS INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number 914ESPA

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)

Patient Problem Perforation of Vessels (2135)

Event Date 06/28/2022

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

Per the field clinical specialist (fcs), during a tavr procedure using a 26mm sapien 3 ultra valve via a transfemoral approach, there was difficulty inserting valve and delivery system.The vessel was predilated with a 16fr dilator, the loader was fully inserted into sheath.The delivery system was in the expandable portion of the sheath when the resistance was met.When the operators attempted to advance the delivery system (ds) again, it visibly buckled likely due to calcium in vessel.The sheath, valve & ds were removed as a unit and upon removal blood pressure dropped.Upon examination of the system, the valve was seen outside the sheath seam and iliac tissue was visualized on the sheath.The patient was intubated, vascular called and balloons inserted to facilitate endovascular repair of the entire left iliac system.Once control of the iliac system was gained, the physicians proceeded with a valve implant via a left subclavian approach due to a concern for not being able to extubate without placing a valve.The valve delivery was uncomplicated through left subclavian.It was noted that >14 units of blood and >10units fresh frozen plasma.Patient passed away 2 days post procedure.

Manufacturer Narrative

In this case, a vascular perforation occurred and was possibly due to procedural factors (device manipulation)and/or calcification of the access vessel that may have contributed to the complaint event.

Manufacturer Narrative

As the device was not returned for evaluation, no visual inspection, functional testing and dimensioning testing could be performed.No imager was returned for review.A device history record (dhr) review was performed related to the manufacturing of the devices and components that could potentially contribute to the complaint and did not reveal an manufacturing nonconformance issues that would have contributed to the complaint event.A lot history review of the work order was performed and revealed no other complaints relating to the reported complaint codes.During manufacturing of the esheath+ 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 nonconformance contributed to the reported events.As no device was returned and there is no evidence to support a manufacturing/design defect potential contributed to the complaint, a manufacturing mitigation review is not required.The following instructions for use (ifu) were reviewed: esheath+ introducer set ifu, commander deliver system ifu, device preparation manual and procedural training manual.The users are instructed on how to screen patients to ensure adequate vessel access and to reduce vascular complications.In addition, a step instruction on how to insert and advance a deliver system through the sheath including mitigation steps and best practices to address high push force are provided.Insertion force through the partially expandable portion can be higher than the push force through the full expandable portion, and in expectation of high friction, use short movements and push deliver system closer to sheath hub.Push force can vary due to angle of insertion, thv sie, vessel diameter, tortuosity, and degree of calcification.Based on the review, no ifu or training deficiencies were identified.The complaints liner punctured and introduce and navigate system through sheath / access vasculature resistance between system components inability to advance through sheath were not able to be confirmed therefore complaint history was no performed.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 for introduce and navigate system through sheath liner punctured and introduce and navigate system through sheath / access vasculature resistance between system components inability to advance through sheath were unable to be confirmed without the returned device or procedural imager.As the device was not returned, engineering was unable to perform an visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing nonconformance was unable to be determined.However, review of the dhr and lot history did not provide an indication that a manufacturing nonconformance would have contributed to the complaint event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of an issues with the sheath during device unpacking or preparation.Per complaint details, the attempted to advance the deliver system (ds) again and it visibly buckled, it was apparent that the entire system needed to be removed.The sheath, valve & ds was removed as a unit and upon removal blood pressure dropped.Upon examination of the system, the valve was seen outside the sheath seam and iliac tissue visualized on the sheath.Per the ifu/training manual, push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.It was also reported that the patient had the presence of calcification.The presence of calcification in access vessels could create a challenging pathway during deliver system insertion through the sheath and lead to resistance.Additionally, calcification can damage the exposed portion of the sheath liner which could lead to immediate cutting/tearing or weaken the liner.A weakened liner can be torn during advancement of the deliver system.As such, available information suggests that patient factors (calcification) ma have contributed to the complaint event.Since no manufacturing nonconformances or labeling and ifu and training deficiencies were identified, no product nonconformance was confirmed, and the complaint occurrence rate did not exceed the applicable trending control limit, no corrective and preventative actions (capa) nor product risk assessment (pra) escalation are required.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15080110
• MDR Text Key: 296367551
• Report Number: 2015691-2022-06929
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103215465
• UDI-Public: (01)00690103215465(17)240309(11)2203102164266566
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2022

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: 03/09/2024
• Device Model Number: 914ESPA
• Device Lot Number: 64266566
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/30/2022; 08/30/2022
• Supplement Dates FDA Received: 08/29/2022; 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female