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

Model Number 9600LDS29A

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Failure to Align (2522); Material Split, Cut or Torn (4008)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2019

Event Type  Death  

Manufacturer Narrative

Udi number: (b)(4). investigation is ongoing.

Event Description

As reported, during a subclavian tavr procedure with a 29mm sapien 3 valve in the aortic position, the commander delivery system balloon "broke" during valve alignment.  there was difficulty during gross valve alignment due to the angle of the esheath coming into the aorta from the subclavian, and the little space available to align.  once the device was out of the sheath, they tried to maneuver into a straight portion.Due to the angles, it was not possible to pull the sheath back further without pulling it into the subclavian ostium, and the valve was aligned in a curved portion of the aorta.They were able to align the valve onto the balloon, but it tore in the process.However, they were not aware of the tear prior to the attempt of deploying the valve.  attempts were made to remove the valve but were unsuccessful.A cut down was performed to remove the valve.On the following day, the patient received a successful transfemoral tavr.

Manufacturer Narrative

Additional information clarified that during the initial subclavian tavr procedure ((b)(6) 2019), the valve could not be deployed due to balloon burst.  the patient was transferred to the icu, intubated and was in critical condition.  the following day ((b)(6) 2019), a sapien 3 valve was successfully implanted via transfemoral approach.  the patient did not recover from the tavr procedure and the family decided to place them on comfort care.  the patient expired a few days later.The exact cause of death was not provided; however, the patient was frail with multiple co-morbidities.  this, in combination with the blood loss and trauma from the aborted tavr case, may have contributed to the patient¿s death.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

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.During manufacturing, inflation balloons are 100% inspected for any defects.Additionally, the lot underwent product verification testing as a requirement for lot release and all testing passed specifications.  these inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.A lot history was reviewed and revealed no additional complaints.  a review of complaint history revealed that the complaint rate did not exceed the october 2019 control limit for the trend category, resistance between devices.The complaints for delivery system difficulty with valve alignment, delivery system withdrawal difficulty valve through sheath, and balloon torn were unable to be confirmed.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 events.A review of the ifu and training manual revealed no deficiencies.Per training manual, the user is instructed to ¿retract the esheath while keeping the delivery system in place until the valve is exposed¿.However, per report, ¿we could not pull the sheath back further without pulling it into the subclavian ostium, and we were forced to align the valve in a curved portion of the aorta¿.Performing valve alignment in tortuous, non-straight vasculature can result in higher forces required to align the valve.Additionally, if the thv is not in a straight section of the aorta during valve alignment, the thv can become unseated/non-coaxial with the flex tip, causing the thv to dive into the flex catheter lumen, and further increase difficulty with valve alignment.Additionally, the ifu warns, ¿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¿.It is likely that the balloon tore when exposed to high forces/tension in the system.Retrieval of a crimped thv in tortuous anatomy may cause non-coaxiality between the thv and sheath tip and result in retrieval difficulty.Additionally, if the delivery system was damaged (i.E.Torn crimp balloon), this could have led to further difficulties in retrieving the delivery system through the sheath.Based on the available information, it is likely that patient (tortuosity) and procedural (valve alignment in non-straight section of aorta; torn balloon) factors may have contributed to complaint events.Since no product nonconformance was confirmed, no ifu/training deficiencies were identified, and the occurrence rates did not exceed the respective complaint control limits, a corrective/preventive action (capa) and a product risk assessment (pra) escalation are not required.  however, a pra was previously initiated to investigate the balloon torn issue and its associated risks and a capa to update ifus to minimize tension build-up in the device (i.E.Valve alignment difficulties), which may result in delivery system damage (i.E.Balloon tear).

• 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: 9452413
• MDR Text Key: 170881049
• Report Number: 2015691-2019-04596
• 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: 11/16/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 9600LDS29A
• Device Lot Number: 62462924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/14/2020; 03/18/2020; 07/23/2020
• Supplement Dates FDA Received: 01/16/2020; 03/23/2020; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention