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

Model Number 9610ES16

Device Problems Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of 29mm edwards sapien 3 transcatheter heart valve, in the aortic position by transfemoral approach.The esheath was able to be easily introduced.During insertion of the delivery system through the 16fr esheath, very high push force was encountered.An extra stiff wire was used for insertion of delivery system through the esheath.It was not possible to advance the commander delivery system and the valve got stuck above the iliac bifurcation.Kinking was visible and the valve was exposed through the liner.It was considered to deploy the valve in abdominal aorta.However, after retracting the balloon it was not possible to deploy the valve.The commander delivery system and esheath were able to be retrieved as a unit with regular maneuvers.There was no patient vascular injury.A new 29mm edwards sapien 3 kit was prepped with new 16 fr esheath, the valve was successfully implanted.

Manufacturer Narrative

The device was returned for evaluation and an engineering evaluation was performed.The esheath was visually inspected and the following was observed: the valve was exposed through the liner tear.Liner partially expanded.The liner expanded section measured 156 mm from strain relief.Liner tear noted with length of 156mm from the strain relief.Liner strands noted at same region as liner tear.Hdpe crushed at the location where the valve was stuck.Distal end of sheath was unexpanded, tip unopened.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 inability to advance through sheath, liner punctured, and liner strand were confirmed.However, no manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Furthermore, no abnormalities were observed during device unpacking or preparation.Per the complaint description, ''it was tried to push a 29mm commander delivery system through 16fr esheath in the patient, but a very high push force encountered (an extra stiff wire was used for insertion of delivery system through the esheath), it was not possible to advance the commander delivery system and the valve got stuck above the iliac bifurcation, with kinking visible, the valve was exposed through liner torn''.Per the imaging evaluation, non-coaxial alignment between the delivery system with crimped valve and sheath was observed in addition to the valve appearing to be outside of the sheath.However, it is unknown what factors may have led to the non-coaxial alignment at this time.Per evaluation of the returned device, the liner was torn and there was presence of liner strands.As non-coaxial alignment was noted in the imaging evaluation, it is possible that a valve strut caught onto the liner during advancement.In addition, excessive device manipulation may have been applied to overcome the experienced resistance further tearing the liner and leading to the valve to protrude through the sheath and the liner strands.As such, available information suggests that procedural factors (non-coaxial alignment, valve caught on liner, excessive manipulation) may have contributed to the complaint events.No labeling/ifu deficiencies were identified.No corrective/preventative actions nor product risk assessment (pra) escalation are 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: 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: 14848268
• MDR Text Key: 301678958
• Report Number: 2015691-2022-06437
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64291377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2022
• 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 Sex: Male