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

Model Number 9610TF23U

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Great Vessel Perforation (2152)

Event Date 01/07/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our (b)(6) affiliate, during a valve-in-valve (viv) procedure with a 23 mm sapien 3 ultra valve in the aortic position by transfemoral approach, into a non-edwards surgical valve a descending aortic rupture occurred when crossing of the aortic arch with the commander delivery system.The sapien 3 valve was not implanted.The patient expired.The delivery system will be returned for evaluation.Per report, it was due to a double rotation of the aorta.In addition, it was noted that the device was kinked and after retrieval pusher was cracked, it is suspected that internal wire of the commander was cracked too.No articulation difficulty of the delivery system noticed.A ct and procedural cine images and were submitted for review.The following observations and impression were made by an edwards physician proctor.Planned viv in pre-existing surgical valve.One sequence revealed an aortography before the planned implantation.A second sequence confirms a rupture of the descending aorta.The delivery system is in place after crossing the arch.A damage can be noticed of the delivery catheter.The root-cause cannot be determined with the limited image data.

Manufacturer Narrative

Update to h6 (type of investigation, investigation findings and investigation conclusion) and h10 to reflect device evaluation.Correction to h6 (device code).The 23mm commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: valve crimped on the inflation balloon and kink observed at the flex tip and compression at the flex tip.Functional testing was performed, and the delivery system was able to flex an unflex with no issues.Dimensional testing was performed on the flex shaft outer diameter and the measurements met specifications.Review of procedural videos/imagery/photographs from the site were performed, and the following was observed: post-procedural device photo showing damaged flex shaft, procedural cine screenshot showing damaged flex shaft during tracking over aortic arch, 3mensio imagery showing radially curved aorta, 3mensio imagery showing double aortic rotation, and aortic angiography, s shape, perceval valve in aortic position.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history record review was performed and did not reveal any related complaints.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 complaint for flex shaft crack was able to be confirmed based on evaluation of the returned device.No manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history, manufacturing mitigation and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.As reported, 'it was noted that the device was kinked and after retrieval pusher was cracked, it is suspected that internal wire of the commander was cracked too.' a 'double rotation of the aorta' was also noted, as well as an s shape curvature seen on the aortic anatomy.A tortuous aorta with sharp angles can create a challenging pathway for tracking.As a result, it is possible the flex shaft was kinked/damaged during insertion/navigation through the patient's anatomy.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures and aortic ruptures are known potential adverse events associated with the overall thv procedure and may require intervention.There are several potential etiologies for ventricular perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.Per ifu and training manuals: tracking over aortic arch: ensure the edwards logo is facing up on the delivery system, use 30 degree to 40 degree lao to provide view of the aortic arch, slowly rotate the flex wheel away from you while tracking over the aortic arch.Note that the delivery system articulates in a direction opposite form the flush port.Additional considerations: do not overflex while tracking over aortic arch, to prevent kinking of the delivery system do not torque the handle while rotating the flex wheel, ensure the edwards logo faces upward throughout flexing and tracking.Note: the flex indicator may be used as a reference to assess degree of articulation in the delivery system throughout procedure.A review of the ifu and training manuals revealed no deficiencies.Per the instructions for use (ifu), aortic rupture is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, available information shows patient (tortuosity) and procedural factors (excessive manipulation) potentially contributed to the reported event.However, a definitive root cause cannot be determined at this time, as the limited imagery data does not show all events capturing the creation of the flex shaft damage and aortic dissection.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 ifu/labeling/training manual inadequacies were identified.Therefore, no product risk assessment no corrective or preventative action is required at this time.

• 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: 13417106
• MDR Text Key: 284824788
• Report Number: 2015691-2022-03739
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2023
• Device Model Number: 9610TF23U
• Device Lot Number: 63901281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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): Death
• Patient Sex: Female
• Patient Weight: 55 KG