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

Model Number 9610TF29

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2022-06809.The investigation is ongoing.

Event Description

As reported from our affiliates in spain, during a transcatheter aortic valve replacement (tavr) procedure of a 29mm sapien 3 valve via right transaxillary approach, the valve embolized into the aorta and was withdrawn to the ascending aorta.It was noted that valve alignment difficulty had been encountered and the delivery system with valve could not be withdrawn due to the patient being hemodynamically compromised.The patient was hemodynamically compromised prior to introduction of any edwards device; however, it was decided to proceed with the tavr procedure while resuscitating the patient.Unfortunately, the patient passed away due to cardiogenic shock.There was no allegation an edwards device caused or contributed to the patient's death.Additional information was received indicating the valve was not aligned between the markers on the delivery system.The decision was made to move forward with deployment, and the valve deployed asymmetrically.The delivery system device was returned for evaluation and the balloon was observed to be torn.

Manufacturer Narrative

Note: this mdr was originally submitted within the 30-day timeline, but due to a technical issue experienced during the submission process, acknowledgment 3 was not received.The mdr was confirmed to be transmitted properly, as we received acknowledgement 1 and 2, but this issue could not be resolved through the esg help desk, so this mdr has been resubmitted.Please reference esg and cesub support reference numbers: (b)(6).A supplemental mdr is being submitted for correction and includes additional information based on device evaluation.The following sections of this report have been corrected/updated: h6 (component code, health effect - clinical code, device code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was returned to edwards lifesciences for evaluation.Visual inspection of the returned device revealed the guidewire lumen and distal balloon assembly were separated from the delivery system.The inflation balloon was bunched over the nose tip.The balloon wings were flared.Gouges were observed on the flex tip.The balloon shaft was noted to have been cut and removed from the delivery system as the balloon shaft and crimp balloon were not returned.Procedural imagery was also provided for evaluation.Per imagery review, prior to valve deployment, the valve was noted to not be aligned between the valve alignment markers and too far proximal on the inflation balloon.During deployment, the valve asymmetrically deployed on the distal end and moved proximally off the inflation balloon.After the deployment attempt, it appeared the delivery system had been pulled back into the ascending aorta.Patient tortuosity was also noted.A device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was also performed and revealed no other events relating to the reported event.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the delivery system usage.Per the ifu, valve deployment in an unintended location and valve migration, malposition or embolization requiring intervention are listed as potential risks associated with the transcatheter aortic valve replacement (tavr) procedure, the bioprosthesis, and the use of its associated devices and accessories.Regarding valve alignment, per the ifu and training manuals, it warns 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 vasculature and relieving compression (or tension) in the system will be necessary.It also warns to not position the transcatheter heart valve (thv) past the distal valve alignment marker to minimize the risk of improper thv deployment or thv embolization.It is noted that a tortuous thoracic aorta is a factor that may make crossing the native valve difficult.For withdrawal of the delivery system, it notes that for subclavian-axillary approach, keep the delivery system inside the sheath until ready to remove all devices as one unit.It also cautions to completely unflex the delivery system prior to removal to minimize risk of vascular injury.Based on the review of the ifu/training manuals, no deficiencies were 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 events for valve not aligned between markers on delivery system and deployed, torn delivery system balloon, and difficulty withdrawing delivery system from the deployed valve were confirmed based on the provided imagery and visual inspection of the returned device.However, the event for valve alignment difficulty during fine adjust was unable to be confirmed.A manufacturing non-conformance was unable to be determined.A review of the device history record, lot history, complaint history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the events.A review of the ifu and training manuals revealed no deficiencies.The event description states, "the gross alignment was performed however the fine adjustment was unable.The valve alignment was attempted in a straight section of the aorta." the provided imagery revealed tortuous angles in the patient's subclavian anatomy.If valve alignment was performed in a tortuous (non-straight section) vasculature, this can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and "dive" into the flex tip.Severe gouges were observed on the flex tip, which is indicative of flex tip diving.If the transcatheter heart valve (thv) is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces and create high tension in the system which can consequentially lead to the reported fine adjustment difficulties.In this case, available information suggests that patient factors (tortuosity) likely contributed to the event.The event description also states, "the valve deployed asymmetrically as it was not between markers (the valve deployed distally but not proximally).The valve embolized into the aorta." the provided imagery revealed the valve was too far proximal to the center marker prior to inflation of the balloon and moved proximally during a deployment attempt.If fine adjustment of the valve was unable to be completed, this likely resulting in the valve's incomplete alignment on the inflation balloon and the subsequent proximal movement and embolization.In this case, available information suggests that procedural factors (incomplete valve alignment) likely contributed to the event.In addition, the event description states, "it was withdrawn to ascending aorta without achieving proximal expansion of the prosthesis or correct removal of the delivery system.Trying to expand the valve however delivery system got stuck inside the valve.Removal was not possible and they broke the delivery system." the difficulty withdrawing the thv may have been related to the expanded balloon material becoming caught on the frame of the valve.In this case, available information suggests that procedural factors (balloon caught on deployed valve) likely contributed to the event.In regard to the observation of the torn balloon during device evaluation, potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a previous product risk assessment (pra).As identified in the pra, tortuosity in the access vessel can create non-coaxial withdrawal angles, resulting in the distal end of the delivery system with crimped valve catching onto the deployed valve.This was evident as the inflation balloon material was bunching distally.As a result, it is possible that excessive manipulation was used to overcome the resistance felt which led to the tearing of the inflation balloon to crimp balloon bond.In this case, available information suggests that patient factors (tortuosity) and procedural factors (balloon caught on deployed valve and excessive manipulation) likely contributed to the event.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 product risk assessment (pra) nor 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15222103
• MDR Text Key: 297858120
• Report Number: 2015691-2022-07311
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193008
• UDI-Public: (01)00690103193008(17)240328(10)64307214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

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: 03/28/2024
• Device Model Number: 9610TF29
• Device Lot Number: 64307214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention