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

Model Number 9600LDS26A

Device Problems Difficult to Remove (1528); Failure to Align (2522); Material Twisted/Bent (2981)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).This is one of two manufacturer reports being submitted for this case.   please reference related manufacturer report no: 2015691-2019-03259.Investigation is ongoing.

Event Description

As reported, during a transfemoral tavr with a 26mm s3 valve in the aortic position, there was difficulty with valve alignment on the balloon with the second valve.  it was decided to retrieve the valve back into the sheath but was unsuccessful due to the valve struts being bent on the proximal end.  the device was unable to be withdrawn and a cut down was performed to remove the system.  the patient is doing well.  this was a known difficult case in which the patient¿s anatomy (heavily calcified and tortuous) most likely contributed to the difficulties.

Manufacturer Narrative

Please reference related manufacturer report no: 2015691-2019-03259.The delivery system was not returned to edwards lifesciences for evaluation.  in addition, no imagery was provided by the site.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, presence of a manufacturing non-conformance was unable to be determined.  during manufacturing, inflation balloons are 100% visually inspected for any defects.  100% distal to proximal visual inspection was performed by both manufacturing and quality.  in addition, work orders undergo product verification testing for lot release.  these inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A lot history review was performed and revealed no other similar complaints for difficulty with valve alignment and withdrawal difficulty valve through sheath.  a device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  the occurrence rates did not exceed the control limits for the applicable trending categories.A review of the instruction for use (ifu) and training manuals for the commander delivery system revealed no deficiencies.  per the ifu: in a straight section of the aorta, initiate valve alignment by disengaging the balloon lock and pulling the balloon catheter straight back until part of the warning marker is visible.Do not pull past the warning marker.  warning: to prevent possible damage to the balloon shaft, ensure that the proximal end of the balloon shaft is not subjected to bending.  warning: 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.Per the procedural training manual: thv can be retrieved through sheath only before thv deployment (still crimped).Ensure the thv is centered on the flextip.Ensure delivery system is locked.Verify the flex catheter is completely unflexed.  retract the thv and delivery system into the sheath ensuring the thv is completely inside the sheath and just past the sheath tip.  ensure the edwards logo on the sheath handle is facing upward.   withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position.Do not re-use the sheath, thv or delivery system once thv is retrieved.A review of the risk management documentation was performed and 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 complaint for delivery system difficulty with valve alignment and withdrawal difficulty valve through sheath were unable to be confirmed, as no relevant procedural video/imagery were provided.  a review of the manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.Additionally, a review of the ifu and training manuals revealed no deficiencies.As noted, the patient¿s anatomy was heavily calcified and tortuous.Tortuosity can lead to increased forces necessary to conduct valve alignment.Additionally, if valve alignment was performed at a bend or angle, it can cause the thv to unseat (noncoaxial placement of valve in relation to the flex tip) from the flex tip during alignment and ¿dive¿ into the lumen of the flex tip, where part of the crimped valve slides into the flex tip lumen.If the thv is unseated during alignment, it can result in even higher valve alignment forces.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.  as noted, the crimped valve was not coaxial with the sheath during retrieval, which may have been a result of heavily tortuous anatomy.If the thv is not coaxial with the sheath tip during retrieval, the thv may catch on the sheath tip, resulting in withdrawal difficulties.Based on available information, patient/procedural (conducting valve alignment in tortuous anatomy and non-coaxial retrieval of thv due to tortuous anatomy) factors may have contributed to the complaint events.Since no product non-conformance or ifu/training deficiencies were identified during this evaluation and the control limits were not exceeded for the applicable trend category, product risk assessment escalation, and corrective/preventative actions are not required.

Manufacturer Narrative

Update sections b2 and h1.Additional information received from the site stated that the patient expired 2 days post tavr procedure.The cause of death was due to a retroperitoneal bleed.

Manufacturer Narrative

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: 8951702
• MDR Text Key: 160887496
• Report Number: 2015691-2019-03261
• 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
• Report Date: 08/06/2019

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: 04/07/2021
• Device Model Number: 9600LDS26A
• Device Lot Number: 62134855
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/08/2019; 03/18/2020; 07/23/2020
• Supplement Dates FDA Received: 10/08/2019; 03/25/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention