MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM, 20MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS20A

Device Problems Failure to Align (2522); Malposition of Device (2616)

Patient Problems Calcium Deposits/Calcification (1758); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924)

Event Date 10/02/2019

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.Udi # (b)(4).

Event Description

During a transfemoral procedure, with a 20mm sapien 3 valve using a commander delivery system with a 14fr esheath, no bav was performed and a planned basilica procedure was completed before the tavr.An effusion was noted and the patient started to decompensate.The patient's pressure dropped and a commander delivery system with valve was urgently inserted while cpr was being performed.  this made it difficult to perform valve alignment visually due to the movement from the cpr.  during valve alignment, the valve ¿moved distal past the balloon on to the nosecone.¿ a decision was made to remove the delivery system leaving the undeployed valve on the wire.A peripheral balloon was then inserted and inflated within the undeployed valve, enough to allow for a larger balloon.The undeployed 20mm s3 valve was then implanted in the distal descending aorta.A 2nd 20mm s3 valve was prepped and then deployed in the native annulus without issue.An echo noted a dissection from the stj to the descending aorta.The patient was placed on ecmo and was transferred for post management care.As reported, there was no difficulty inserting the delivery system into the sheath.There was no difficulty with valve alignment or fine adjust.There was no tension noted by the physician or was the system torqued or manipulated.  the patient's annulus was mildly calcified and mildly tortuous.The patient's minimum luminal diameter (mld) access vessel measure 6.2mm x 8.2mm.There was mild calcification and no tortuosity of the iliac vessel and measured 4.8mm x 5.1mm.

Manufacturer Narrative

Correction death and date added and type of reportable event changed to death upon review of medical records, a coronary occlusion occurred during a planned attempted basilica valve in valve.  the basilica procedure was performed due to low left and right coronary height and high risk for obstruction of right coronary given the patient¿s prosthetic valve type and distance to coronary ostia.The initial 2 passes with basilica wire encountered resistance and were repositioned.Upon repositioning before a third attempt, leaflet perforation was noted and the patient became hypotensive.A posterior effusion was noted on echo with severe aortic insufficiency.Given worsening hemodynamic status a decision was made to quickly replace the aortic valve despite low right coronary in the hopes of achieving better hemodynamic status followed by a pericardiocentesis of the posterior fusion.The 20 mm edwards sapien 3 valve was placed in the body.Prior to balloon positioning the patient became profoundly hypotensive and pulseless and cpr was instigated.The balloon of the edwards delivery system was withdrawn to place the stent valve and the appropriate portion of the balloon as per usual.When examined fluoroscopically; however, it became apparent that the balloon had been pulled back too far and was partially beyond the distal portion of the stent valve.The situation could not be salvaged and the initial delivery system was withdrawn.The valve remained on the wire in the abdominal aorta just distal to sheath.A 8 mm peripheral balloon was placed in the valve and partially deployed it.Subsequently the valve was expanded in the descending aorta with a 18mm balloon to low pressure.A second valve was then prepped and successfully deployed in the aortic annulus under rapid pacing.Pt placed on cardiopulmonary bypass at this time.Aortic angiogram and echocardiogram after deployment of valve showed a good valve replacement with little residual pvl.There was however new inferior st segment elevation on the monitor and the right coronary artery was unable to be visualized and had been occluded by the new valve placement.The artery was able to be wired and ballooned with restoration of flow and decrease in st segment elevation.No stent was placed due to platelet dysfunction.A pericardiocentesis was performed of the anterior portion however it was unclear whether the drain was in the pericardium or pulmonary artery.A posterior drain was placed with resolution of posterior effusion.During the process, the echocardiogram revealed that there was possible aortic dissection and an aortogram was performed, which showed type a dissection extending from just above the annulus throughout the ascending arch and descending aorta and stopping at the level of the first tavr valve that was deployed at the abdominal aorta.A discussion was had with cardiothoracic surgery about converting to an open procedure for repair of the aorta and exploration to assess any areas of ongoing bleeding/perforation.The decision was made however that the patient had a prohibitive risk for emergent cardiothoracic surgery and ought to be transferred to the intensive care unit on mechanical circulatory support in the hopes that she stabilized and would not require any type of surgical exploration given the incredibly high mortality rate that would result.The pericardial drains were sutured in place. the patient received multiple units of red blood cells platelets and ffp throughout the course of the procedure.The patient was transferred to the intensive care unit in critical/grave condition though hemodynamically stable at present on mechanical circulatory support.After discussion with family, the patient was made limited code.The patient went into v tach, was shocked twice with absence of pulse.The patient expired one day post procedure.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imaging was provided that shows the patient¿s anatomy.The 3mensio imaging revealed that there is tortuosity and calcification present in the patient.The access vessel anatomy reveals calcification and tortuosity.During manufacturing, the delivery system is visually inspected, and testing is performed throughout the process.Per procedure, the inflation balloons are 100% visually and dimensionally inspected.Per procedure, each guidewire shaft is fully inserted into the marker band verification fixture and 100% visually inspected.Per procedure, prior and after the balloon pleat, fold and forming process the balloons are 100% visually inspected.During final inspection, per procedure, the entire device is inspected distal to proximal by both manufacturing and quality.In addition, product verification (pv) testing is performed on a sampling basis for physical defects, and delivery system final alignment testing.The lot met statistical requirements as requirement for lot released.These inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaints.A device history record (dhr) was reviewed and no manufacturing non-conformances were identified that would have contributed to the event.A lot history review was performed and revealed no other complaints related to the reported event.A review of complaint history from november 2018 to october 2019 revealed other returned complaints for the commander delivery system (all models and sizes) for the reported events.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.Available information suggests that patient/procedural factors may have contributed to the event.A review of complaint history revealed that the occurrence rate did not exceed the october 2019 control limit for all the trend categories.The ifu, device preparation manual, and procedural training manual were reviewed instructions/guidance on device preparation/usage.The procedural training manual provides guidance on delivery valve alignment.Factors that assist with valve alignment are as follows: unlock, pull the balloon catheter straight back at the y-connector until part of the warning marker is visible and lock, do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure, rotate the balloon lock away from you to lock and towards you to unlock.Lock/unlock symbols are found on the balloon lock, check delivery system before valve alignment.If kinked, do not use, re-lock the device after unlocking every time, slowly rotate the fine adjustment wheel towards you to center the thv exactly between the valve alignment markers with no gap or overlap, and if additional fine adjustment is needed, unlock and rotate the fine adjustment wheel away from you until part of the warning marker is visible and relock.Note, do not position the thv past the distal valve alignment marker, this will prevent proper thv deployment, perform valve alignment in the straight section of the aorta, compression may be observed in the distal portion of the flex catheter during valve alignment, and diving may be observed between the thv and the flex catheter tip during valve alignment.To correct valve alignment issues: move to a different straight section of the aorta (for diving only), if using the balloon catheter, push forward slightly, and then continue pulling back until part of warning marker is visible, and if using the fine adjustment wheel, reverse and then continue with fine adjustment until thv is centered exactly between the valve alignment markers.It is additional noted that if valve alignment is not performed in a straight section, there may be difficulties performing this step which may lead to delivery system damage and inability to inflate the balloon.Utilizing alternate fluoroscopic views may help with assessing curvature of the anatomy.If excessive tension is experienced during valve alignment, repositioning the delivery system to a different straight section of the aorta and relieving compression (or tension) in the system will be necessary.There were no ifu or training deficiencies identified.The complaint for was unable to be confirmed as the device was not returned and procedural imagery of the dislodgement was not provided.Investigation of complaint history, lot history, and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.As reported, ¿the 1st delivery system was inserted, and the patient began to crash and cpr was initiated.At this point the patient was ¿violently¿ moving on the table.The ds was pulled back too much, and it was then noted the valve moved distal on the balloon¿.As such it is possible that during this process the delivery system was excessively manipulated.Per the provided imagery and case notes, the patient¿s anatomy had calcification and tortuosity present.If there was excessive manipulation of the delivery system due to the patient¿s condition and cpr, the valve could have caught onto the calcification/tortuosity in the patient¿s anatomy and moved off the balloon.Valve deployment in unintended location is listed in the instructions for use (ifu) as a potential risk associated with the tavr procedure, the bioprosthesis, and the use of its associated devices and accessories.There may be cases in which the valve is not able to be deployed at the intended location for various reasons.This may require deploying the valve at a non-target location, typically in the descending aorta.Although, generally well tolerated, the long-term effects are not completely understood.In this case, as a result, available information suggests that patient factors (calcification/ tortuosity) and/or procedural factors (excessive manipulation) may have contributed to the complaint events.However, a conclusive root cause is unable to be determined.No manufacturing non-conformances, labeling, training, or ifu deficiencies were identified.A review of complaint history revealed that the occurrence rate did not exceed the october 2019 control limit for all the trend categories.Therefore, no product risk assessment nor corrective and preventative action is required at this time.

Manufacturer Narrative

This is one of two reports being submitted for this case.Reference mfg.Report no.2015691-2019-03982.

Manufacturer Narrative

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

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM, 20MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9241878
• MDR Text Key: 166139325
• Report Number: 2015691-2019-03980
• 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,Followup,Followup
• Report Date: 10/02/2019

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: 03/03/2021
• Device Model Number: 9600LDS20A
• Device Lot Number: 62035456
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 10/31/2019; 11/27/2019; 07/23/2020
• Supplement Dates FDA Received: 10/28/2019; 11/20/2019; 12/02/2019; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention