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

Model Number COMMANDER DELIVERY SYSTEM UNKNOWN

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown.For this reason, the date that the manuscript was published (15-dec-2022) was used as the occurrence date.The investigation is ongoing.A supplemental report will be completed upon completion.Device not accessible.

Event Description

Edwards reviewed the literature article, ''cranial dislocation of infrarenal aortic endoprostheses during transcatheter aortic valve replacement,'' by dr.Atul singla et.Al.(tex heart inst j.2022;49(6):e217613).Abstract: this report describes the complexity of transcatheter aortic valve replacement in which rare complications sometimes occur, even at experienced centers.This is a case of cranial migration of an infrarenal aortic aneurysm endograft while advancing the balloon expandable prosthesis through the infrarenal aorta, which was subsequently successfully treated by deploying a thoracic endoprosthesis after deployment of the aortic valve bioprosthesis.Through review of the article the following complaint was identified: an 84-year-old man with a history of evar with gore c3 excluder aaa prosthesis, extender endoprosthesis placed proximally for type 1 endoleak, and severe symptomatic aortic valve stenosis was referred to the hospital for management of valvular disease.After evaluation, the heart team elected for a transfemoral tavr under moderate sedation with a 23-mm sapien 3 prosthesis (edwards lifesciences).A 14f edwards sheath was placed in the right common femoral artery and advanced under fluoroscopic guidance, with the tip landing just proximal to the abdominal aortic graft.Standard procedural techniques followed until physicians noted resistance with advancement of the 23-mm valve out of the sheath.The valve was advanced over a safari wire using a commander delivery system (edwards lifesciences).Upon entry into the abdominal aorta, it was noted that the extension graft had migrated with the tip of the commander system.Physicians attempted to slide the valve through the extension graft, but this only resulted in further migration of the cuff into the descending thoracic aorta.A goose neck snare was used in hope of stabilizing the endograft, but physicians were unsuccessful in snaring the prosthesis.Then, through the left femoral access, a wire was placed across the cuff extension and a 20-mm tyshak balloon (bvm medical) was advanced proximal to the endograft and inflated to pin the endograft in place.Using the flex feature of the valve delivery system, the physicians deflated the trapping balloon and advanced the valve through the extension graft without further cuff migration.The valve was then successfully deployed using standard techniques.The delivery device was removed, and post deployment imaging confirmed a favorable result.At this stage, there was no thoracic or abdominal aortic dissection and the migrated endograft was in stable position.Vascular surgery clinicians were called to assist, and the 14f sheath was replaced with a 22f sheath, which was advanced under fluoroscopic guidance through the dislodged proximal cuff in the descending thoracic aorta.Through this sheath, a 31-mm x 31-mm x 10-cm length thoracic gore tag endoprosthesis was advanced and positioned within the dislodged cuff.The graft was deployed and an aortogram showed a widely patent thoracic stent graft and no aortic wall damage.However, both renal arteries were noted to be stenosed with thrombus.With a therapeutic activated clotting time of 280 seconds, chronic thrombus had likely migrated from behind the cuff during dislodgment.Both renal arteries were then stented with viabahn heparin-bonded covered stents with brisk flow in the right renal artery and good perfusion of the inferior pole of the left kidney.The patient had acute kidney injury postprocedure, with a rise in creati-nine from a baseline level of 1.4 mg/dl to 3.5 mg/dl.Urine output was good, and the patient did not require further intervention.At 6-month follow-up, the patient was doing well, with resolution of the severe, symptomatic aortic stenosis, and maintenance of adequate renal function with a new baseline creatinine level of 2.9 mg/dl.

Manufacturer Narrative

The device was not returned for evaluation.Therefore, a no product return engineering evaluation was performed.3mensio imagery provided, and the following was observed: calcification and infrarenal aortic stents within the patient anatomy were present.Additional imagery showed tyshak trapping balloon inflated and the delivery system and thv was able to pass while the graft remained in place.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 device interaction with pre-existing implantable device and difficulty tracking system through anatomy were confirmed based on evaluation of the provided imagery.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 were unable to be performed as no work order # was provided.A review of ifu/training materials revealed no deficiencies.As reported, ''upon entry into the abdominal aorta, it was noted that the extension graft had migrated with the tip of the commander system.'' as the delivery system is advanced through the patient's anatomy, it is likely the distal end of the delivery system caught onto the pre-existing aortic graft and resulted in the reported complaint events.The thv training manuals instruct the operator on proper introduction and advancement of the delivery system with crimped valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.Operators are also instructed to use fluoroscopy as the primary method of visualization for tracking, positioning and deployment.In this case, there was no allegation or indication a device malfunction contributed to the adverse event.Available information suggests that patient factors (pre-existing stent) may have contributed to the complaint event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra) 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: 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: 16428276
• MDR Text Key: 310075559
• Report Number: 2015691-2023-11014
• 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: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMMANDER DELIVERY SYSTEM UNKNOWN
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male