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

Model Number 9610TF29

Device Problems Failure to Align (2522); Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

Udi reference number: (b)(4).Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during a transfemoral tavr procedure, the operator had difficulty aligning the valve and attempted to deploy the 29mm sapien 3 valve.The valve embolized into the ascending aorta and a second valve had to be deployed in the annulus.Initially the physician reported having difficulty while trying to align (fine and gross) the 29mm sapien 3 valve exactly between the markers.The patient was reported to have a highly tortuous anatomy and the physician aligned the valve in a straighter section.Although the valve alignment issue was not resolved, the decision was made to proceed with valve deployment.During deployment, the valve ¿jumped¿ backwards into the ascending aorta and was not fully deployed.The valve was pulled back and anchored in a part of the ascending aorta.A new 29mm sapien 3 valve was then prepped and implanted in the annulus.The patient was reported to be doing fine after the procedure.The patient¿s iliacs/aorta were reported to have a moderate degree of calcification and tortuosity.Note: this description summary pertains to the delivery system.

Manufacturer Narrative

H10: this is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2020-11218.

Manufacturer Narrative

Additional information: h6 and h10: the delivery system was not returned to edwards lifesciences for evaluation, as it was discarded by the facility.No relevant photographs, videos, or imagery were provided for review.During manufacturing of the delivery system, the delivery system and components were inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A device history record review (dhr) was performed and did not reveal any manufacturing non-conformance that would have contributed to this complaint event.A lot history review was performed and did not reveal any similar complaints.As the complaint was unable to be confirmed and the control limit for the associated trend category was not exceeded for march 2020, a complaint history review was not required.The instructions for use (ifu), the preparation training manual and the procedural training manual were reviewed for instructions/guidance on device preparation/usage.Per the procedural training manual, ¿perform valve alignment in the straight section of the aorta¿.No ifu/training deficiencies have been 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 complaint was unable to be confirmed.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.A review of manufacturing mitigations supports that the device has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.The complaint description stated that ¿the patient had a severely tortuous anatomy and valve alignment was performed in the least tortuous section possible.¿ performing valve alignment in tortuous vasculature can result in higher forces required to align the valve.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.If the thv is not in a straight section of the aorta during valve alignment, the thv can become unseated/non-coaxial with the flex tip, causing the thv to dive into the flex catheter lumen, and further increase difficulty with valve alignment.While a definitive root cause is unable to be determined, available information suggests that patient factors (tortuosity) and procedural factors (performing valve alignment in non-straight section of aorta) may have contributed to the complaint events.As the complaint occurrence rate for the applicable trend category did not exceed monthly control limits, neither pra escalation nor corrective actions were required at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9894978
• MDR Text Key: 190125224
• Report Number: 2015691-2020-11219
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/03/2020

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 Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 9610TF29
• Device Lot Number: 62445259
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/28/2020
• Supplement Dates Manufacturer Received: 03/29/2020; 04/28/2020; 07/23/2020
• Supplement Dates FDA Received: 03/29/2020; 05/02/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention