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

Model Number 9610TF26

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Failure to Align (2522)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2022

Event Type  Injury  

Event Description

As reported by our edwards affiliate in france, prior to a transfemoral tavr procedure, it was noted that the right femoral artery was heavily calcified and could not be used.The left femoral artery severe tortuosity was reported.The left femoral artery was used for the tavr approach.During the alignment of a 26mm sapien 3 valve onto the commander delivery system balloon, 'the incidence on the amp was not good.' the x-ray control machine was not properly set-up and the image was distorted.It was thought that the alignment was performed on a flat surface of the aorta, when in fact the delivery system was bent, resulting in the delivery system 'breaking'.This was observed prior to the deployment attempt.Blood in the inflation device confirmed the balloon leakage.The decision was made to remove the devices.Due to the vessel tortuosity, the devices could not be removed.The patient was transferred to the operating room for surgical removal of the devices.At the time of the report, the patient was doing well.A new tavr procedure is planned in a few weeks.

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

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis could not be performed.Review of the provided case imagery revealed the delivery system and valve were outside of the sheath tip.Two valve struts were also observed to be bent outwards.Device history review (dhr) review was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other similar complaints.In this case, the complaints for 'valve alignment difficulty or inability - fine adjust' and 'failure - balloon leak' were not able to be confirmed as neither the complaint device nor applicable procedural imagery were provided for evaluation.The complaint for 'difficulty or inability to withdraw system with valve through sheath' was confirmed by the provided imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis; therefore, a manufacturing non-conformance was unable to be determined.Additionally, a review of the dhr and lot history 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.The complaint description states, 'during procedure, some difficulties were encountered during valve alignment, and it was noted that something was not correct.Once in the ascending aorta, due to wrong imaging (the x-ray control machine was not set up properly and the image was seen distorted), it was thought to be in the straight section of the aorta but actually, the commander was a little bent, making the balloon being damaged when loading the valve; 'while pulling negative pressure on the inflation balloon, blood was seen in the inflation syringe and it was noted that the commander delivery system balloon was punctured.' as difficulties with valve alignment were reported, it is possible that the combination of the unseated valve and high alignment forces may have caused the valve to puncture the balloon, resulting in the observed leakage.The case notes revealed the patient had 'very large tortuosities.' per complaint details, 'the patient was transferred to the operating room to have a laparotomy to remove the devices.The case was aborted and another approach has been planned to implant the valve.The patient was doing well post procedure' as previously mentioned, the case notes revealed the patient had 'very large tortuosities.' the presence of tortuosity can create suboptimal angles and lead to non-coaxial alignment between the valve and sheath tip during withdrawal.As the valve remained crimped on the balloon during retrieval, it can get caught on the sheath tip and contribute to withdrawal difficulties.If valve alignment was performed in a non-straight of 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.In this case, available information suggests patient factors (vessel calcification, tortuosity) may have contributed to the reported alignment difficulties.Procedural factors (withdrawal of the crimped valve) may have contributed to the reported withdrawal difficulties and subsequent vascular surgery to remove the devices.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 this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No 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: 15722400
• MDR Text Key: 303033297
• Report Number: 2015691-2022-08982
• 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: 12/16/2022

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 Model Number: 9610TF26
• Device Lot Number: 64466734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/03/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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
• Patient Age: 84 YR
• Patient Sex: Male