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

Model Number 916ESPA

Device Problem Material Integrity Problem (2978)

Patient Problem Vascular Dissection (3160)

Event Date 11/22/2022

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.This is one of two manufacturer reports being submitted for this case.

Event Description

As reported by our affiliates in (b)(6), during the placement of 29mm sapien 3 valve, by transfemoral approach, the surgeon did the cut down.The introducer was inserted, and while advancing the commander delivery system valve some resistance was noted.The valve was implanted and the system was withdrawn.While withdrawing the introducer, it began to bleed.The surgeon thought that the tip of the introducer dissected the iliac.It was noticed that the esheath was broken in the part that expands and the tip was indented.The iliac was repaired and the patient was stable, still in the hospital.It was mentioned by medical team several vascular accidents (two with the open method and one percutaneous).

Manufacturer Narrative

Supplemental report submitted to include additional information received through follow-up.It was repored that the patient expired in intensive care unit due to another complication, the patient had a dnr.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-10081.

Manufacturer Narrative

Supplemental report submitted to include additional information received throughthe device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.Imagery was provided of the patient's vessels, the following was noted: tortuosity and calcification were present with in the access vessels.Video of the device was provided and showed the condition of the sheath after being used in the procedure; the following was noted: soft tip damage.Tip opened as designed.Liner fully expanded.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 difficulty advancing delivery system through sheath and distal tip damage were confirmed through returned imagery.The complaint of sheath damaged was unable to be confirmed through returned imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr, and lot history, and complaint history did not provide any indication that a manufacturing non-conformance 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 any issues with the sheath during device unpacking or preparation.Per complaint details, ''during procedure, the esheath was inserted, and while advancing the commander delivery system with valve some resistance was noted.Despite the resistance encountered, the sapien 3 valve was implanted and the system was withdrawn.Upon esheath removal, it began to bleed.It was thought that the esheath tip dissected the iliac, but it was noticed that the esheath was broken in the expandable part and the tip was indented''.Per the ifu/training manual, push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' tortuosity and calcification were seen in returned patient imagery in the patient's access vessel.Vessel tortuosity can subject the devices to suboptimal angles and lead to non-coaxial alignment in the advancement of the delivery system through the sheath.Non-coaxial advancement of the delivery system can lead to resistance through increased contact between the crimped valve and sheath inner lumen.Calcification can reduce the vessel lumen diameter and increase restriction leading to resistance.Calcification can also cause damage to the sheath distal tip if encountered during insertion.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint events.However, a definite root cause was unable to be determined at this time.No ifu/training manual deficiencies were identified.Therefore, no corrective action nor product risk assessment (pra) escalation is required at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: ESHEATH PLUS INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine 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: 15999686
• MDR Text Key: 305681816
• Report Number: 2015691-2022-10080
• Device Sequence Number: 1
• Product Code: DYB
• 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: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2023

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 Model Number: 916ESPA
• Device Lot Number: 64522757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 12/21/2022; 01/18/2023
• Supplement Dates FDA Received: 01/13/2023; 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male