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

Model Number 9610TF26

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354); Difficult To Position (1467); Material Rupture (1546); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in the (b)(6), during a transfemoral tavr procedure, during deployment of the 26 mm sapien 3 valve, there was a problem with valve alignment and it looked like the balloon was ¿bunching¿ up as it was pulled back.  the balloon burst and the system had to be retrieved. another system was used and patient was noted to be doing ¿ok¿.

Event Description

As reported by the edwards affiliate in the (b)(6), during a transfemoral tavr procedure in the aortic position, during deployment of the 26mm sapien 3 valve, there was a problem with valve alignment and it looked like the balloon was ¿bunching¿ up as it was pulled back.  the balloon burst and the system had to be retrieved. another system was used and patient was noted to be doing ¿ok¿.

Manufacturer Narrative

The delivery system was returned to edwards lifesciences for evaluation.The device underwent visual and dimensional inspection.  visual inspection revealed the crimp balloon was torn proximal to the i/c bond. the valve remained on the inflation balloon.  the valve strut appeared bent on the outflow side.  balloon bunching/enlarged profile was observed in the distal portion of the inflation balloon.Flex tip gouges were observed. no other abnormalities were observed on the returned device.Due to the returned condition of the device (crimp balloon torn), no relevant functional testing was able to be performed. the complaint for ¿balloon ¿ torn¿ was confirmed through visual inspection.  during dimensional inspection, double wall thickness measurements were taken on the crimp balloon.  a thickness measurement deviating from the specification could have contributed to the balloon tear or be indicative of a manufacturing issue. all measurements taken met specifications. during manufacturing, the following visual inspections and tests are performed throughout the process: general inspection for s3 balloons, crimp balloon molding process, crimp balloon to inflation balloon laser bond, balloon pleat, fold, & forming, 100% final inspection by both manufacturing and quality, functional product verification testing for commander and tensile product verification testing for commander.  inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing issue contributed to the reported events.  a device history record (dhr) review performed revealed no issues that would have contributed to the complaint events.    review of lot history revealed two (2) other similar complaints related to ¿balloon ¿ torn¿.  both were confirmed but no manufacturing non-conformance were identified.  a review of complaint history for the edwards commander delivery system (all models, all sizes) for the past 12 months (may 2017 to april 2018) revealed thirty-eight (38) other complaints with returned devices for ¿delivery system ¿ difficulty with valve alignment¿.A review of complaint data for april 2018 revealed that the complaint occurrence rate did not exceed the control limit for the trend category of ¿valve alignment difficulties¿.  a review of complaint history for the edwards commander delivery system (all models, all sizes) for the past 12 months (may 2017 to april 2018) revealed eighty (80) similar complaints with returned devices for ¿balloon ¿ torn¿.  no manufacturing non-conformances were identified.  a review of complaint data for april 2018 revealed that the complaint occurrence rate exceeded the control limit for the trend category of ¿damaged¿.See product risk assessment for further details.  the edwards commander delivery system instructions for use, device preparation manual and procedure training manual were reviewed for instructions and guidance for proper use of the commander delivery system.  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 events are anticipated risks of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.    the complaints for ¿delivery system ¿ difficulty with valve alignment¿ and ¿balloon ¿ torn¿ were confirmed based on the condition of the returned device.  however, no manufacturing non-conformances were found in the returned device.  review of lot history and dhr revealed no manufacturing non-conformances that could have contributed to the complaint events.Ifu/training material revealed no inadequacies.  a review of manufacturing mitigation also supported that the device has proper inspections in place to detect issues related to the complaint events. as no issues were noted during device prepping and de-airing, the device had no damages out of box.  it is likely that the torn balloon occurred during the procedure.A review of complaint history data revealed that patient/procedural factors can result in difficulty with valve alignment. potential issues include: performing valve alignment in a non-straight section of the aorta can cause the thv to ¿unseat¿ (non-coaxial placement of the valve in relation of the flex tip) from the flex tip during alignment and ¿dive¿ into the flex tip lumen resulting in higher than normal alignment forces. although imagery of the valve alignment procedure and information regarding the location or condition of valve alignment was not provided, gouges observed on the flex tip suggesting evidence of the thv diving into the lumen of the flex tip. if the thv is unseated during alignment, if can result in higher than usual valve alignment, and can create tension in the system in order to achieve final alignment position. an engineering study was previously performed to confirm this condition and was able to recreate high valve alignment forces with valve diving under simulated conditions (tortuous anatomy).  residual fluid in the balloon, which can enlarge the inflation balloon profile and create interference with the valve during valve alignment. this was recreated in a previously performed engineering study as well.  the balloon was reportedly bunched up/enlarged profile in the distal portion could be an indicative of the fluid remaining in the balloon.  a pra was previously initiated and documented for the tearing of the crimp balloon material proximal to the inflation balloon to crimp balloon bond. the pra identifies increased alignment forces experienced during the procedure as possible root cause of the complaint event. if valve alignment required higher than usual forces, it is possible that the extra force applied to overcome the valve alignment difficulty resulted in the weakening and subsequent tearing of the bond between the inflation balloon and crimp balloon.  although a definitive root cause is unable to be determined at this time. available information suggests that patient and/or procedural factors may have contributed to the complaint events.  no manufacturing or ifu/labeling inadequacies were identified.  available information suggests that patient and/or procedural factors may have contributed to the complaint event.No corrective or preventative action is required at this time. however, per management discretion, the balloon torn issue and the associated risks have previously been assessed and documented in a pra.

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; one edwards way; irvine CA 92614
• MDR Report Key: 7470421
• MDR Text Key: 107333937
• Report Number: 2015691-2018-01581
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/23/2020
• Device Model Number: 9610TF26
• Device Lot Number: 61239684
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 07/12/2018; 09/19/2018; 07/23/2020
• Supplement Dates FDA Received: 05/16/2018; 07/13/2018; 10/01/2018; 02/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR