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

Model Number 9600LDS29J

Device Problems Calcified (1077); Difficult or Delayed Positioning (1157); Failure to Align (2522); Difficult to Advance (2920)

Patient Problems Calcium Deposits/Calcification (1758); Infarction, Cerebral (1771); Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Aortic Dissection (2491)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu) cardiovascular injury, such as perforation dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.According to the thv training manuals, risk factors for aortic dissection, hematoma or annular rupture during the tavr procedure include significant thv over sizing, severely obliterated sinuses of valsalva, porcelain aorta and/or presence of bulky calcification and narrow calcified stj.In addition, advanced age, female gender, small body weight, and steroid dependency can also be contributing factors.The sapien 3 valve relies on native valve calcium to securely anchor to the annulus.Despite this beneficial aspect of calcium, bulky calcium can increase the risk of calcific nodule displacement into the vasculature, which can lead to vascular injury.At times the extent and distribution of calcium can impair ease of delivery of the valve, correct positioning of the valve, deployment of the valve and procedural success.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate in addition to procedural factors (tracking difficulty, manipulation of the devices), patient factors (female gender, advanced age ¿ (b)(6) years, moderate-severe vessel tortuosity, moderate-severe valvular calcification, moderate aortic root calcification) likely contributed to the reported advancement and valve alignment difficulties and the subsequent descending aortic dissection/rupture.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Event Description

As reported by our affiliate in (b)(6), a descending aortic dissection occurred during the transfemoral tavr procedure.Prior to the tavr procedure, it was determined that the native annulus was borderline between a 26mm and a 29mm valve.A 29mm sapien 3 valve was selected based on observations during the balloon aortic valvuloplasty (bav).Due to severe aortic tortuosity between the descending aorta and the aortic arch, difficulty was experienced during the advancement of the commander delivery system and valve alignment.The sapien 3 valve was not able to cross the native valve and the sapien 3 valve frame became ¿tangled¿ in the native leaflets.During the attempt to cross the annulus the blood pressure decreased.The delivery system was pulled back to the ascending aorta and percutaneous cardiopulmonary support (pcps) was introduced.Additional bav was performed with a non-edwards balloon three times.The delivery system was then able to cross the native valve.A 29mm valve was deployed with 3ml less than nominal volume in a final 80:20 aortic/ventricular (a/v) position as intended.Prior to the esheath withdrawal, angiography showed no injury in the access route.After the esheath and pcps were withdrawn, the blood pressure decreased.Echocardiography did not show a pericardial effusion or an aortic root rupture but a descending aorta dissection and bilateral pleural effusion were observed.Aortography revealed an aortic dissection with the entry at the descending aorta and re-entry at the aortic arch.As hemodynamics did not improved, a stent graft was deployed in the descending aorta.The patient left the operating room with improved hemodynamics.The native annular diameter measured 30.0mm x 23.0mm by ct, with a valve area of 560.0mm2.Moderate-severe valvular calcification and moderate aortic root calcification was reported.Moderate-severe access vessel tortuosity and no vessel calcification was reported.Per the operator, severe thoracic aortic tortuosity led to delivery system tracking difficulty and valve alignment difficulty.Bav of the aortic valve was difficult due to the severely calcified and stenosed aortic valve, although no balloon indentation was observed during the bav.

Manufacturer Narrative

Additional information: evaluation codes.The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device, visual inspection, functional testing and dimensional analysis were not able to be performed.Ct imagery of the patient vasculature was provided for review.Moderate-severe tortuosity in the access vessel and aorta were observed.Lot history review revealed one other complaint related to delivery system ¿ difficulty with valve alignment.No other complaints were found for delivery system ¿ tracking difficulty or delivery system ¿ difficulty crossing native annulus.Complaint history review from (b)(6) 2018 through (b)(6)2019 for the commander delivery system revealed additional returned complaints for delivery system ¿ tracking difficulty, delivery system ¿ difficulty crossing native annulus and delivery system ¿ difficulty with valve alignment.A review of the complaint history revealed that the occurrence rate did not exceed the (b)(6) 2019 control limit for the appropriate trend categories.Device history record 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.Per ifu and training manuals ensure edwards logo is facing up on the delivery system.Use 30° to 40° lao to provide view of the aortic arch.Slowly rotate the flex wheel away from you while tracking over the aortic arch.Note: the delivery system articulates in a direction opposite from 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 edwards logo faces upwards throughout flexing and tracking.Per ifu and training manuals during valve alignment a gap between the thv and distal valve alignment marker may result in difficulty crossing.An overlap cannot be reversed and may prevent proper thv deployment.Note: do not bend or apply torque to the proximal end of the balloon catheter throughout the procedure.Warning: do not position thv past the distal valve alignment marker.This will prevent proper thv deployment.Additional considerations: 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 the 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.Note: thv moves in only one direction relative to the balloon.Perform valve alignment in the straight section of the aorta.Per the ifu and training manuals when crossing native valve ensure the flex catheter tip is flush with the thv for support during crossing.Be patient! do not force the thv.Use short movements to prevent ¿jumping¿ of the thv into the ventricle.Factors that can make it difficult to cross: heavy calcification, wire bias into commissure, horizontal aorta, tortuous thoracic aorta, flex catheter kinked, inadequate bav.When experiencing difficulty crossing: make sure wire is correctly extended at apex, pull tension on the wire or reposition, add some distal flex or remove some partial flex, pull system back and re-advance.During the manufacturing process, the delivery system components undergo multiple 100% inspections.During final inspection, the entire assembled delivery system undergoes visual inspections and functional testing.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-conformances contributed to the reported events.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.In this case, the reported complaint was not able to be confirmed.Due to unavailability of device, the presence of a manufacturing non-conformance was unable to be confirmed.However, a review of complaint history and manufacturing mitigations revealed that it is unlikely a manufacturing issue contributed to the complaint.Additionally, a review of ifu/training manuals revealed no deficiencies.As reported, moderate to severe tortuosity was present in the patient access vessel and descending aorta.Tortuosity in the vasculature can cause issues with valve alignment and tracking of the delivery system, requiring more force to align the thv on the inflation balloon (during gross and fine thv alignment) and to advance to the delivery system forward, respectively.Additionally, since thv alignment was initially attempted in a non-straight section of the aorta (descending aorta), the thv may have been unseated from the flex tip and dived into the flex tip lumen, causing further difficulties with thv alignment.Per the procedural manual, if valve diving is observed, the user should move the thv to a different straight location of the aorta and re-attempt valve alignment.While attempting to cross the native valve, it was noted that the thv frame was getting entangled in the native leaflets.However, after further dilation of the native valves with a bav, the thv was able to cross the native valves.This indicates that the native valves may not have been sufficiently predilated initially, contributing to the difficulties with native valve crossing.Per the operator¿s opinion, the severely calcified valve caused issues with dilation of the native valves.Although a definite root cause could not be determined, procedural factors (attempting valve alignment in a non-straight section of the aorta), in additional to patient factors (tortuous anatomy) may have contributed to the reported tracking and valve alignment difficulties.Patient factors (severe valvular calcification), in addition to procedural factors (insufficient pre-dilation of the native valve) may have contributed to the reported crossing difficulties.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

Manufacturer Narrative

Additional information: section b2: outcomes; section f10: patient code; section h10: narrative text.As reported through the japanese tavi registry, one day post valve deployment, paralysis was observed.A brain magnetic resonance imaging (mri) revealed new-onset cerebral infarction.The symptoms associated with the cerebral infarction improved within 2 months.Per medical opinion, the cerebral infarction was related to the tavr procedure.The event was not related to the device.The native annular diameter measured 30.0mm x 23.0mm by ct, with a valve area of 560.0mm2.Moderate-severe valvular calcification and moderate aortic root calcification was reported.Moderate-severe access vessel tortuosity and no vessel calcification was reported.Per the instructions for use (ifu), permanent or transient neurological events including stroke are potential adverse events associated with the tavr procedure and the use of the edwards thv devices.According to literature review, and as documented in a clinical technical summary written by edwards lifesciences, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing tavr.Risk factors correlating with a number of patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during tavr are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during tavr demonstrated that the majority of procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no important differences in the frequency of late strokes between tavr and avr patients.After tavr, there appears to be a more significant proportion of early strokes occurring < 24 h post-procedure, but tavr patients with multiple co morbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate in addition to the procedure itself, patient factors (female gender, advanced age ¿ 85 years, moderate-severe valvular calcification, moderate aortic root calcification) likely contributed to the cerebral infarction one day post valve implant.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.

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: 8841124
• MDR Text Key: 152640310
• Report Number: 2015691-2019-02813
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: 9600LDS29J
• Device Lot Number: 61974673
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 09/11/2019; 03/15/2020; 07/23/2020
• Supplement Dates FDA Received: 09/13/2019; 03/26/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 85 YR