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

Model Number 9610TF29

Device Problems Fluid/Blood Leak (1250); Failure to Align (2522)

Patient Problem Rupture (2208)

Event Date 11/11/2022

Event Type  Death  

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

As reported by our edwards affiliate in germany, prior to the transfemoral tavr procedure, it was noted that 2 layers of stents were present in the ilio-femoral anatomy.During the procedure, difficulties were encountered passing the esheath through the stented anatomy.During the procedure, extensive friction was experienced during valve alignment.The valve was not able to be pushed to the distal marker.It was determined that this was likely caused by the circular ring 'crushing' the crimped valve onto the delivery system balloon at that location.When the commander delivery system and valve were placed in the native annulus, it was noted that the valve was displaced about 3mm proximal to the handle.During valve deployment, as the delivery system balloon expanded, it was observed that the inflow end of the valve did not open.The delivery system balloon ruptured on the inflow side of the valve during deployment.Case imagery showed a circular ring at the distal end of the valve constraining deployment.The delivery system was removed.A non-edwards balloon was used in an unsuccessful attempt to complete the valve deployment.The balloon also ruptured.An unsuccessful attempt was then made to retract the valve and deploy it in the aortic arch or descending aorta.During the manipulation of the valve and delivery system, an aortic rupture occurred.The patient expired during the procedure.The devices were discarded and will not be returned for evaluation.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on device evaluation.The following sections of this report have been corrected/updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was returned to edwards lifesciences for evaluation.Visual inspection of the returned device revealed a clean separation between the inflation/crimp balloon bond, indicating a crimp balloon tear.The guidewire was observed to be intact in the y-connector, indicating the distal end was separated due to the cut on the flex shaft.A cut through the flex shaft distal to the handle was noted.A section of the guidewire was also observed to have been cut.A section of the flex shaft was observed to have been peeled away due to the cutting and withdrawal attempt.Functional testing was performed and revealed the balloon shaft was able to be pulled to the warning marker, lock and full fine adjustment was also able to be utilized with no abnormalities observed.Additionally, the locknut/collet force measurements were taken and revealed the device met specification.Double-wall thickness measurements of the crimp balloon were also taken, and it was found to be within specifications.Procedural imagery was provided for review.A pta balloon was observed pre-dilating the pre-existing arterial stents.When introducing the sheath, a ring was pushed distally from the stent area.The sheath appears resistance upon advancement through the stent.The delivery system was advanced through the sheath with tortuosity in the patient's descending aorta.The transcatheter heart valve (thv) was positioned in the annulus and tortuous horizontal aorta was observed.Prior to deployment, a ring was observed around the inflow side of the thv.A gap was between the thv and the distal valve alignment marker as the thv was not centered between the markers.A valve deployment attempt was observed an uneven thv expansion occurred due to the ring.With continued attempt to deploy, the balloon ruptured.The thv embolized into the aorta as it was observed that the thv was pulled into the ascending aorta with the ring.The commander delivery system was observed to be pushed and pulled within the patient's aorta.The delivery system was cut outside the patient, and the flex shaft/balloon shaft were removed from the patient.Other balloons were observed to be inflated while the balloon and guidewire lumen of the delivery system remained in the thv.After other inflation attempts, the remaining delivery system was pulled proximally; however, the distal end appeared to be stuck with the partially expanded thv in the patient's aorta.The remaining delivery system was observed in the patient's descending aorta with the partially expanded thv.The guidewire was removed.Imagery of the patient's anatomy was also provided for review.Calcification and pre-existing stents were observed in the patient's arterial anatomy.Tortuosity was also observed within the patient's arterial anatomy.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was also performed and revealed no other events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per the ifu/training manuals, it warns that if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Based on the review of the ifu/training manuals, no deficiencies were identified.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 events for valve alignment difficulty or inability during fine adjust, torn balloon, interventional device interacting with a pre-existing implantable device, and difficulty or inability to withdraw the delivery system from the deployed valve were confirmed based on evaluation of the returned device and provided imagery.No manufacturing non-conformances were identified during the evaluation.A review of the dhr, complaint history, and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the events.A review of the ifu and training manuals revealed no deficiencies.Regarding the valve alignment difficulty, as reported, "extensive friction was experienced when performing valve alignment, it was unable to push the valve to the distal marker, likely because a circular ring was crushing the crimped valve onto the balloon at that location." per imagery review of the patient's anatomy, tortuosity was present within the patient's descending aorta.In this case, it is likely that valve alignment was performed in a non-straight section of the vasculature which 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 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.It is also possible that due to the constricting nature of the ring structure on the crimped transcatheter heart valve (thv), aligning over the balloon was more difficult due to the inability to expand as the thv profile expands.However, without applicable procedural imagery, a definitive root cause was unable to be determined.In this case, available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in non-straight section and negative device interaction) may have contributed to the event.Regarding the torn balloon, as reported, "it was observed that the distal end of the valve (in-flow side) did not open.The commander delivery system balloon ruptured and the valve embolized." evaluation of the returned device revealed a separation from the inflation/crimp balloon bond.As "excessive friction" was experienced during valve alignment, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.As difficulty performing valve alignment was reported, it is possible that increased forces of performing valve alignment may have weakened the balloon enough to withstand inflation pressures towards the end of deployment or when excessive pressures are met.Due to the constriction of the ring observed on the thv, excessive inflation pressure was likely used to combat the abnormal expansion.However, without applicable procedural imagery or return of the distal end of the delivery system, a definitive root cause was unable to be determined.In this case, available information suggests that patient factors (tortuosity) and/or procedural factors (valve alignment in non-straight section, negative device interaction and excessive inflation force) may have contributed to the event.Regarding the interventional device's interaction with the pre-existing implantable device, as reported, "after post-dilatation, fluoroscopy showed a x-ray-dense, ring-like structure of unclear origin around the inflow of the valve stent, which seemed to compress it and which also corresponded to the rupture of the balloons." the exact nature of the pre-existing ring like structure is unknown; however, it is likely that advancing through the arterial stents may have caused the ring to latch around the delivery system and thv.If the thv was wrapped around the ring and restricted, it can cause difficulties during valve alignment and deployment.In this case, available information suggests that patient factors (pre-existing stent) may have contributed to the event.Regarding the difficulty or inability to withdraw the delivery system from the deployed valve, as reported, "due to the pre-existing aortic pathology and the delivery system with the fixed valve stent, it was not possible to easily retreat the material into the descending aorta." it is likely that due to the altered balloon profile from the burst, the remaining balloon material may have caught onto the partially expanded valve with the constricting ring and led to the reported withdrawal difficulties.In this case, available information suggests that procedural factors (withdrawal of torn balloon and balloon caught on partially deployed valve) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No product risk assessment (pra) nor corrective or preventative actions are required.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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: 15882331
• MDR Text Key: 304501078
• Report Number: 2015691-2022-09542
• 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
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9610TF29
• Device Lot Number: 64555287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2022
• 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; Death
• Patient Age: 87 YR
• Patient Sex: Male