MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Device was discarded.

Event Description

Edwards received notification from our affiliate in switzerland.As reported, it was a case of an implant of a 29mm sapien 3 transcatheter heart valve in aortic position by transfemoral approach.The patient had vascular tortuosity and severe annular calcification.During the procedure, valve fine adjustment was very difficult (four times fine adjustment wheel reload).It was impossible to cross the native valve so it was decided to abort the case.During delivery system and valve retrieval, the valve frame struts were bent outwards, which was dangerous for the femoral artery and there was no option to pull the valve inside the esheath.The esheath was damaged as valve bent struts were tearing it off.According to angio, esheath was torn.An occlusion balloon was set above location and patient was treated in the or to remove the devices and the artery was patched.The patient was hemodynamic good and overall stable.If the patient experiences a good recovery, they will be treated with a ta access approach.As per medical opinion, the root cause of the event is related to the patient anatomy and severe annulus calcification.

Manufacturer Narrative

This is one of four manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-11458, eu 2015691-2023-10722, and 2015691-2023-11459.

Manufacturer Narrative

The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Imagery was provided by the site and revealed the following: the thv with bent outflow struts was still crimped on crimp balloon and with inflation balloon bunching.Tortuous access vasculature was noted.The patient had calcified native leaflets.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this 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.The complaints valve alignment difficulty, withdrawal difficulty, and inability to cross native annulus were confirmed.As the device was not returned for evaluation, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance could not be determined.A review of the device history record and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.As reported, ''valve fine adjustment was very difficult (four times fine adjustment wheel reload).'' patient 3mension imagery was provided and tortuosity was observed in patient anatomy.It is possible that valve alignment was conducted in a non-straight section.If valve alignment was performed in a tortuous (non-straight section) vasculature, this can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and 'dive' into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of 'diving' (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.Without further information or applicable imagery, a definitive root cause is unable to be determined at this time.However, available information suggests patient (tortuosity) and procedural factors (valve alignment in non-straight section) may have contributed to the complaint events.As reported, ''again impossible to cross native valve so decided to abort case.'' imagery of patient anatomy provided revealed calcification of the native leaflets.The presence of calcification can cause interaction between the advancing delivery system with thv and calcified nodules present on the native leaflets, obstructing the valve crossing and resulting in the reported difficulty crossing.As such, available information suggests patient (calcification) contributed to the reported event.As reported, ''while delivery system and valve retrieval, the valve frame struts were bent outwards, which was dangerous for the femoral artery and there was no option to pull the valve inside the esheath.'' in imagery provided by the field, tortuosity of the access vasculature was observed in patient vasculature.Tortuous patient anatomy could result in non-coaxial angles of withdrawal during system retrieval, potentially causing the reported withdrawal difficulties because of sub-optimal angles created during retrieval of the delivery system through the sheath.It is possible that the non-coaxial withdrawal configuration may have resulted in the crimped valve catching on the sheath tip and causing the reported withdrawal difficulty.In addition, it is possible the bent valve strut may have exacerbated the withdrawal difficulties.A definitive root cause is unable to be determined.Available information suggests that patient (tortuosity) and/or procedural factors (non-coaxial withdrawal (crimped valve), withdrawal of altered valve profile) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) is required.Complaint historie s 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: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 16345213
• MDR Text Key: 309261628
• Report Number: 2015691-2023-10721
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 64580368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male