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

Model Number 9600LDS29A

Device Problems Difficult or Delayed Positioning (1157); Failure to Align (2522)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208); Aortic Dissection (2491); Blood Loss (2597)

Event Date 06/29/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).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, prior to the transfemoral tavr procedure, it was noted that the patient¿s creatine level was high.Therefore, the decision was made to conserve contrast resulting in poor imaging during the case.Difficulties were encountered during the valve alignment and fine adjustment of the 29mm sapien 3 valve.It was noted that the balloon may not have been aligned properly and that the balloon appeared to be ¿too far¿.Alignment was completed in the abdominal aorta.During deployment, the valve embolized into the aorta.The valve was recaptured and brought back over the arch.At this point, the patient started to become hypotensive.It was determined that the patient was bleeding, but the source could not be determined.The valve and delivery system were removed, and an unsuccessful attempt was made to tamponade the bleed with a balloon.The patient expired during the tavr procedure.The exact cause and source of the bleeding could not be determined.It was speculated that an aortic dissection or rupture may have occurred during the retrieval of the embolized valve.

Manufacturer Narrative

Per the instructions for use (ifu) cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.Ascending aortic dissection may occur when multiple attempts are made to cross the stenotic native valve, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torqueing of the flex catheter may be helpful in solving the problem.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 patient 3mensio report revealed tortuosity and calcification present in the access vessels (left) and aorta.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 complaints for the first complaint event and 1 other complaint for the second complaint event.As the complaints were unable to be confirmed, a complaint history review is not required.Per the ifu and training manuals slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap.Note: fine adjustment wheel functions only when the balloon lock is locked.Do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Compression may be observed in the distal portion of the flex catheter during valve alignment.Diving may be observed between the thv and the flex catheter tip during valve alignment.To correct: move to a different straight section of the aorta (for diving only).If using a balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible.If using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.Perform valve alignment in the straight section of the aorta.During the manufacturing process, the delivery system undergoes multiple visual inspections and testing.The delivery system components undergo multiple 100% visual and dimensional inspections.During final inspection, the fine adjust, collet/shaft clearance and collet engagement undergo 100% functional testing.Additionally, functional product verification testing is performed on a sampling basis.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.In this case, the complaints were not able to be confirmed without the returned device or case imagery.The presence of manufacturing non-conformances were not able to be determined.A review of lot history, dhr, and manufacturing mitigations supported that a manufacturing non-conformance likely did not contribute to the event.As seen in the provided 3mensio imagery, the patient¿s vasculature did show a degree of tortuosity and this may have contributed to the reported valve alignment difficulties.Performing valve alignment in a tortuous anatomy can result in high alignment forces when attempting to move the valve over that valve alignment markers.The resulting action can induce tension in the delivery system leading to difficulty when attempts are made to align valve over the inflation balloon and/or using the fine adjustment wheel to control the fine positioning of the thv.Under simulated conditions (valve alignment performed in kink fixture to represent a tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Additionally, it was reported that the balloon may not have been properly aligned after valve alignment.Per the complaint description it was mentioned that the balloon appeared to be ¿to far¿.It is possible that the valve was not properly aligned on the balloon and may have led to asymmetric deployment of the balloon causing the valve to embolize.Although a definitive root cause was not able to be determined without the return of the complaint device or procedural imagery, available information suggests that procedural factors (performing valve alignment in tortuous aorta / release of build-up tension in system), in addition to patient factors (vessel tortuosity) may have contributed to the reported valve alignment issues, resulting valve embolization, aortic dissection and subsequent patient death.While a definitive root cause was unable to be determined, the available information suggests that patient factors (tortuosity) may have contributed to the complaint event.Since no product non-conformances or ifu/training manual deficiencies were identified, no corrective or preventative action is 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; 1 edwards way; irvine CA 92614
• MDR Report Key: 10311041
• MDR Text Key: 199977648
• Report Number: 2015691-2020-12632
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

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: 01/30/2022
• Device Model Number: 9600LDS29A
• Device Lot Number: 62968317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/04/2020; 07/23/2020
• Supplement Dates FDA Received: 09/04/2020; 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR