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

Model Number 9610ES14

Device Problems Peeled/Delaminated (1454); Material Separation (1562); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-17266.

Event Description

Edwards received notification from our affiliate in new zealand.As reported, this was an implant case of a 26mm sapien 3 valve in aortic position by transfemoral approach.During the procedure, patient experienced cardiac arrest after valve deployment and cpr was being performed while withdrawal of the commander delivery system.Withdrawal difficulties were found and the tip and balloon of the commander delivery system came off apart from the proximal part and lodged in the patient's iliac bifurcation.The esheath was found damaged at the distal tip after removal.The patient underwent a surgery to remove the distal part of the commander delivery system.The patient passed away two days post-procedure.As per medical opinion, the root cause of the event may be related to the fact that the commander delivery system was not totally unflexed or that the balloon was not totally deflated when brought back into the esheath.As per the preliminary evaluation of the returned devices, it was found that the esheath liner was totally delaminated and the distal tip was split.

Event Description

Edwards received notification from our affiliate in new zealand.As reported, it was an implant case of a 26mm sapien 3 valve in aortic position by transfemoral approach.Patient had a cardiac arrest and valve deployment was okay but performed during cpr.Withdrawal of the commander delivery system was also performed during cpr.Withdrawal difficulties were found and the tip and balloon of the commander delivery system came off apart from the proximal part and lodged in the patient's iliac bifurcation.The esheath was found damaged after removal.The patient underwent a surgery to remove the distal part of the commander delivery system.The patient passed away two days post-procedure.The root cause of the death was not provided but it was stated that the patient was very fragile.As per medical opinion, the root cause of the event may be related to the fact that the commander delivery system was not totally unflexed or that the balloon was not totally deflated when brought back into the esheath.As per the preliminary evaluation of the returned devices, it was found that the esheath liner was totally delaminated and the distal tip was split.

Manufacturer Narrative

Supplemental report submitted to correct b5.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The returned sheath was visually examined, and the following was observed: sheath shaft is slightly curved.Distal tip opened and liner fully delaminated from distal tip to strain relief.Radiopaque c-marker band was detached from sheath and not returned.One (1) kink was observed on sheath shaft at approximately 8 cm from distal tip.One longitudinal cut observed on sheath shaft at 4 cm from strain relief and 1 cm in length approximately.The distal tip was split.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 of sheath liner delamination, sheath distal tip split, sheath damaged, and component separated were confirmed through evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr, complaint history, and lot 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, no abnormalities were reported during device unpacking or preparation.As reported ''withdrawal difficulties were found and the tip and balloon of the commander delivery system came off apart from the proximal part and lodged in the patient's iliac bifurcation.The esheath was found damaged after removal.The patient underwent a surgery to remove the distal part of the commander delivery system.The patient passed away two days post-procedure'' per returned product evaluation, the liner was delaminated, the radiopaque c-marker band was missing, and the distal tip was found to be split.Additionally, follow up information revealed that ''delivery system was not totally unflexed or that the balloon was not totally deflated when brought back into the esheath.'' it was also revealed that mild tortuosity and moderate calcification was present in the patient's access vessel.Per ifu/training manual ''completely unflex the delivery system [.] ensure the balloon is completely deflated''.Withdrawal of an flexed delivery system with an altered balloon profile can lead to the system to catch onto the sheath liner.In addition, non-coaxial alignment between the devices can also lead to delivery system to catch onto the sheath liner, especially if patient factors such as calcification and tortuosity near the sheath distal tip are present within the patient anatomy.As a result, the operator may apply excessive manipulation to overcome any difficulty, which can further delaminate the liner as the delivery system is pulled through the sheath.In addition, as excessive manipulation is applied to overcome the withdrawal difficulty, the balloon can cause the distal tip split and retract the sheath liner as it is withdrawn resulting in the reported delamination and radiopaque c-marker separation.It is also possible that this excessive manipulation could lead to the shaft damage noted.However, it was revealed that when asked if the sheath was damaged ''yes but it was then cut open to be examined to see if the balloon had become lodged within''.As such, it is also possible that back table manipulation could have lead to the shaft damage.As such, available information suggests that procedural factors (withdrawal of a flexed delivery system, altered balloon profile, excessive manipulation, back table manipulation) may have contributed to the complaint events.No labeling/ifu deficiencies were identified.Therefore, no further escalation is required.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: EDWARDS ESHEATH INTRODUCER SET
• 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: 18288479
• MDR Text Key: 330155296
• Report Number: 2015691-2023-18193
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610ES14
• Device Catalogue Number: N/A
• Device Lot Number: 65069023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 12/18/2023; 01/18/2024
• Supplement Dates FDA Received: 01/09/2024; 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• 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