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

Model Number 9600LDS29A

Device Problem Failure to Align (2522)

Patient Problem Cardiac Perforation (2513)

Event Date 02/02/2021

Event Type  Death  

Manufacturer Narrative

This individual report provides data received from the thv/tvt registry.This is one of two manufacturer reports being submitted for this case.Investigation still ongoing.

Event Description

Per the field clinical specialist (fcs), during a subclavian tavr procedure with a 29mm sapien 3 valve and commander delivery system, the delivery system balloon 'watermelon seeded' during inflation.Tension built up and the system "jumped" resulting in a left ventricle perforation with subsequent patient demise.Valve alignment was initially attempted in the esheath, but there was too much tension.The valve was advanced just outside the sheath and valve alignment was completed there.They were able to align the valve in between the markers and proceeded with crossing the native aortic annulus.During deployment, the valve was rising aortic, so forward pressure was placed on the delivery system in attempt to counteract.Only the distal portion of the commander delivery system balloon filled upon inflation, resulting in watermelon seeding and the partially expanded valve was in the ventricle.At this point, tension built up, and with continued forward pressure, the system jumped and perforated the left ventricle.Tee revealed a large effusion.The patient was converted to open surgery, upon discovery of the lv laceration and discussion of the patient's comorbidities, it was determined that they would not withstand perfusion and repairs needed.The decision was made to call the case and the patient expired at the table.

Manufacturer Narrative

Voluntary report number: mw5099642.It was reported by the facility in a voluntary event report that during valve deployment, the balloon 'watermelon-seeded' from the valve with mal-deployment of the edwards valve across the native aortic valve.An attempt at re-positioning the valve caused ventricular displacement of the apparatus and perforation of the lateral wall of the lv.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation, however, a device history record review of the work orders related to the manufacturing of the devices and components that could potentially contribute to the complaint were conducted.Review of the work orders did not reveal any manufacturing nonconformance issues that would have contributed to the complaint event.Additionally, a lot history review was performed and revealed no other complaints relating to the complaint codes below.During the manufacturing process, the commander delivery system is visually inspected and tested several times.During manufacturing, the delivery system balloon component was 100% inspected.During the final inspection, the delivery system underwent 100% inspection.Additionally, all manufacturing lots are subject to product verification (pv) testing on a sampling basis.All samples passed product verification testing for this lot number.No failures occurred during product verification testing and the lot was released.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.An imaging review was performed on imaging (intraprocedural video clips of cine images and 3mensio) provided by the facility.The following observations and impressions were made by an edwards physician's proctor and seen in this order: access via left subclavian approach, the patient had a horizontal aorta, the esheath was seen in the ascending aorta, the wire appears to be in the middle of the left ventricle, valve alignment appears to be done partly in the esheath, the valve was not positioned against pusher and not aligned to the distal marker.The pusher was then seen the against valve, the valve was across the native annulus and was not aligned to the distal marker.Due to poor imagery quality and the camera angle, it was not possible to determine the valve distance from distal marker.Balloon inflation appears faster than recommended, the distal part of balloon inflates first, valve and pigtail in good position, balloon in left ventricle outflow tract, the valve expands asymmetrically and moves proximal towards the flex catheter, and the entire delivery system with valve moves forward into the left ventricle.Conclusion and recommendations: unable to determine tortuosity and minimum luminal diameter of the left subclavian artery as these were not listed in the 3mensio work-up of the patient's screening ct images.The patient had a challenging anatomy with a horizontal aorta (54 degrees).Gross alignment of the valve was completed with the flex catheter still within the esheath.It is recommended pulling the esheath back and allowing the delivery system to be aligned outside the esheath.The valve and pigtail were in good position, however, the valve did not align to the distal marker.Due to imaging quality and the camera angle, the determination of the distance from the marker is unable to be confirmed.Inflation of the balloon appears faster than recommended.A slower inflation may have allowed a dog-bone effect of the balloon.The valve expanded asymmetrically as the valve was not on the working length of the balloon and moved proximal towards the flex catheter during inflation.The entire delivery system with valve was pushed forward into the left ventricle.The following instructions for use (ifu) were reviewed: commander ifu, commander prepping manual, commander procedural training manual, and subclavian training manual.Based on this review, no ifu/training deficiencies were identified.The complaint for valve movement on balloon was confirmed base on the provided imagery.However, the complaint for valve alignment difficulty was not able to be confirmed due to no device being returned and no available imagery of the valve alignment.Engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing nonconformance was unable to determined.A review of the dhr, lot history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manual revealed no deficiencies.As reported, valve alignment was initially attempted in the sheath but generated too much tension on the system.The valve was advanced just outside the sheath and valve alignment was completed there.As specified in the training manual, valve alignment should be performed in a straight section of the aorta (not inside the esheath).Additionally, per case notes and imagery review, access to aorta was achieved via left subclavian approach.It was noted that the patient did have a challenging anatomy due to the presence of a horizontal aorta [54 degrees].Valve alignment difficulty is likely to occur if the system is under any tension during valve alignment.It is possible that initially performing valve alignment in the sheath, and then subsequently completing valve alignment in the tortuous non-straight section of the aorta, may increase tension felt within the system.With increased tension in the system and valve alignment conducted in a non-straight section of the aorta, the thv may become unseated/non-coaxial with the flex tip and resulting in higher forces to align the valve as specified in the reported event.Available information suggests that patient factors (tortuosity) and procedural factors (gross alignment inside the sheath) may have contributed to the reported difficulty during valve alignment.A review of past complaints for similar reported issues suggests that patient and/or procedural factors may have contributed to the reported valve movement on balloon.A product risk assessment (pra) was previously initiated to investigate and document the valve movement on balloon issue and its associated risks.A capa was also previously initiated to document the investigation and drive corrective/preventative actions as appropriate.In the pra, build-up of tension within the delivery system during the procedure (e.G.Via valve alignment in a non-straight section, torquing of the system, patient tortuosity, etc.) was identified as possible cause of valve movement on balloon.The subsequent release in tension from flex tip retraction could then have contributed to the observed valve movement.Similarly in the reported complaint, built-up tension in the system during valve alignment was released during retraction of the flex tip, resulting in the reported valve movement and misalignment on the delivery systems inflation balloon.Subsequently, if valve deployment was performed with the valve not fully aligned onto the inflation balloon and increased risk of embolization can occur.In this case, per an internal imaging review, it was clarified the valve expanded asymmetrically as the valve was not on the working length of the balloon and moved proximal towards the flex catheter during inflation.The entire delivery system with valve was pushed forward into the left ventricle contributing to the patient injury.Available information suggests that patient (tortuosity) and/or procedural factors (valve alignment performed in not straight section) may have contributed to the valve movement on balloon.However, a definitive root cause was unable to be determined.Edwards has provided guidelines and instructions to the physicians in the ifu and training materials/refresher training on how to properly perform valve alignment, deploy the thv, and manage embolism.Users are informed of the residual risks associated with use of the delivery system and sheath through the potential adverse events section in the instructions for use (ifu) and/or device training materials.The benefits of the system outweigh the risks associated with valve alignment difficulties and incorrect positioning of the thv.No labeling, training, or ifu deficiencies were identified.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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: 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: 11389698
• MDR Text Key: 233949553
• Report Number: 2015691-2021-01595
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)220831(10)63370027
• 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: 04/30/2021

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: 08/31/2022
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 63370027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/27/2021
• Supplement Dates Manufacturer Received: 03/16/2021; 04/20/2021
• Supplement Dates FDA Received: 04/10/2021; 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other