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

Model Number 9750CM26A

Device Problems Difficult or Delayed Positioning (1157); Fluid/Blood Leak (1250); Inflation Problem (1310); Failure to Align (2522)

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

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the field clinical specialist, during a transfemoral transcatheter aortic valve replacement procedure with a 26mm sapien 3 ultra valve in the aortic position, there was difficulty with the fine alignment and ¿it was tough to get the valve fully aligned but appeared successful on fluoro¿. during deployment, when the team went to inflate the commander delivery system, ¿the inflation did not occur and there was blood back in the syringe¿.The delivery system was safely removed from the patient and a second valve and delivery system was used for a successful implant.Upon removal of the first delivery system it was observed that the balloon was almost completely under the aligned crimped valve.It appeared that the location of the disruption/hole in the material was not in the balloon itself, but more in the shaft closer to the where the valve is next to the delivery system on insertion.The patient had very tortuous anatomy in the descending aorta.

Manufacturer Narrative

The 26mm commander delivery system was returned with locked at default position, no fine adjust, and no flex.The delivery system was fully inserted through loader assembly with the 3 way stopcock attached.A review of imagery provided showed calcification present in the access vessel and observed thoracic aorta tortuosity.  visual inspection was performed and the following was observed: crimp balloon tear proximal to i/c bond; valve was on inflation balloon, and distal inflation balloon was bunched; balloon wings flared; observed gouges on flex tip.  dimensional inspection was performed and the double wall thickness of the crimp balloon proximal to the tear was measured.  all measurements met specification.  functional testing was performed and the fine adjust could be rotated and fully functioning as intended.The balloon shaft was able to pull to warning marker or valve alignment position.  the handle was able to lock.During manufacturing, the delivery system and component were both visually inspected and tested several times throughout the process.All inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.  all pv testing passed specification.  these inspections support that it is unlikely that a manufacturing non-conformance contributed to the reported complaints.A device history record (dhr) review was performed and revealed no manufacturing issues that may have contributed to the reported event.  a lot history review was performed and revealed no other similar complaints for balloon torn and handle fine adjust difficulty.A review of complaint history from(b)(6)2019 through (b)(6)2020 revealed additional similar returned complaints for the commander delivery system (all models and sizes) for balloon torn and handle fine adjust difficulty.The complaints were confirmed, but no manufacturing nonconformities were identified during the evaluation.Available information suggests that patient and/or procedural factors may have contributed to the complaint events.  a review of the complaint history revealed that the occurrence rate did not exceed the (b)(6)2020 control limit for the trend categories.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 complaints for balloon torn and handle fine adjust difficulty were confirmed based on visual inspection of the device.No manufacturing non-conformances were identified during device evaluation as no abnormalities were observed during visual inspection, dimensional measurements and functional testing.Furthermore, a review of lot history, complaint history, manufacturing mitigations, and dhr did not provide any indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.As reported, ¿the patient had very tortuous anatomy in the descending aorta.¿ per imagery review, patient had tortuous anatomy, especially, there was severely tortuosity at thoracic aorta, which was the section to perform valve alignment.The presence of tortuosity (such as in a non-straight section of the aorta) could cause the thv to unseat (non-coaxial placement of valve in relation to the flex tip) from the flex tip during valve 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 higher than usual valve alignment forces and can create tension in the system to achieve final alignment position.Flex tip gouges were observed on the returned devices, which were indicatives of high valve alignment force and tension occurred during valve alignment step.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.Potential root causes for separation of the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment.If the physician performed valve alignment in a non-straight section of the aorta, it may have resulted in increased forces being applied to the bond area.In addition, residual volume left in the balloon may also contribute to increased forces during valve alignment, which could lead to a weakening of the inflation and crimp balloon bond.Another previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a material failure in the area in question.Although a definitive root cause is unable to be definitively determined; available information suggests that patient factors (tortuosity anatomy) and/or procedural (valve alignment in non-straight section of the aorta) may have contributed to the complaint events.Since no edwards defect was identified to have contributed to the complaint events, no corrective/preventative actions (capa) are required at this time.  a capa and a product risk assessment have previously been initiated to address the failure mode and assess the risks associated with balloon torn.

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: 10124021
• MDR Text Key: 194824075
• Report Number: 2015691-2020-12083
• 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
• Report Date: 05/12/2020

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: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: 9750CM26A
• Device Lot Number: 62778300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 07/23/2020
• Supplement Dates FDA Received: 08/11/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1