MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600LDS29A

Device Problems Positioning Failure (1158); Inflation Problem (1310); Failure to Align (2522); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During insertion of a 29mm sapien 3 valve with a commander delivery system in a surgical stenotic mitral valve by transvenous approach, valve alignment difficulty occurred due to the patient¿s anatomy and the balloon failed to inflate when deploying the valve.As reported, during valve alignment with a 29mm s3 commander delivery system, with the nose cone across atrial septum into the left atrium, the valve would not align after many attempts, including bringing the system into the inferior vena cava (ivc).This caused the balloon to ¿bunch up¿ and it was decided to pull the system into the esheath, and removed as a unit.A 2nd 16 esheath was inserted without difficulty and a 2nd 29mm s3 and system prepped and inserted into the left atrium with the nose cone.There was "much" difficulty aligning the valve on balloon, multiple fine alignment resets were performed to get the valve between markers.The valve crossed the existing surgical valve with some difficulty.During an attempt to deploy the valve the balloon failed to inflate, indicating a compromise of balloon integrity.The 2nd system was removed as a unit similar to the 1st system.A 3rd 16fr esheath was inserted without difficulty into the femoral vein, and the 3rd 29mm s3 commander system prepped.The 3rd system was inserted through the esheath with alignment performed in the ivc/right atrium without difficulty.The delivery system crossed the septum and surgical valve with some difficulty.The valve was successfully deployed 80:20 atrial/ventricular.The transeptal puncture was repaired with an asd closure device.The patient was stable and transferred for post management care.The issues were attributed to anatomical conditions.

Manufacturer Narrative

The commander delivery system was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A lot number was not provided the manufacturing mitigation documents reviewed were the latest revision released at the time of the complaint occurrence.These inspections and tests are representative of those that the device went through during manufacturing.During the manufacturing process, the entire delivery system is visually inspected and tested several times.Per procedure, the inflation balloons are 100% inspected for the following dimensions: working length, balloon diameter, proximal and distal leg inner diameters (id), proximal leg outer diameter, and single or double wall thickness.Per procedure, the crimp balloon features are 100% dimensionally inspected for the following, distal length, proximal length, distal id, proximal id and single or double wall thickness.Per procedure, prior to the balloon pleat, fold and forming process the balloon is 100% visually inspected for size and contamination under magnification.After the process, the balloon is 100% inspected for fold lines and distorted/pinched folds.During final inspection, per procedure, the entire device is inspected by both manufacturing and quality for damage or missing components.The inflation and crimp balloon are inspected to distorted/pinched folds.The flex shaft is inspected for kinks, bends, cracks, deep scratches in the stent area that expose the braid, or flash/exposed metal on stent section.Fine adjust, collet/shaft clearance, and collet engagement are 100% functionally tested.The commander delivery system is 100% leak tested and post testing the balloon catheter is visually inspected.In addition, product functional testing and tensile testing was performed on the finished work order under a sampling basis during product verification testing per procedure.Testing included inspection for physical defects or damage, fine adjust verification to ensure valve alignment positon, balloon burst testing and the inflation/crimp balloon inspected for tears or separation.These inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.A device history records (dhr) review could not be performed as the lot number was not provided.A review of the complaint history from january 2018 to december 2018 revealed other similar returned complaints for the trend categories above were confirmed.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.A review of complaint history revealed that the occurrence rate did not exceed the december 2018 control limit for all the trend categories.A review of edwards lifesciences risk management documentation was not 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, per procedure.Due to the unavailability of the device and relevant imagery, the complaints for ¿delivery system ¿ difficulty with valve alignment - unable¿ and ¿balloon ¿ torn¿ were unable to be confirmed.Since the device was not returned, engineering was unable to perform any visual, functional, or dimensional analysis.As a result, the presence of a manufacturing non-conformance was unable to be confirmed.A review of the complaint history and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.It is likely that patient/procedural factors contributed to the valve alignment difficulty.As reported, ¿a 2nd 29mm s3 and system prepped and inserted into the left atrium with the nose cone.There was ¿much¿ difficulty aligning the valve on balloon, multiple fine alignment resets were performed to get the valve between markers.¿ and ¿the issues were attributed to anatomical conditions.¿ per supplemental training manual, the operator is instructed to ¿perform valve alignment in the straight section of the inferior vena cava.¿ if valve alignment were performed with the nose tip across the atrial septum, it is likely that alignment was performed at a bend.Performing valve alignment at a bend or angle (such as in a non-straight section of the anatomy) can cause the thv to unseat (non-coaxial 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 higher than usual valve alignment forces.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high enough valve alignment forces to potentially cause a tear in the crimp balloon.Corrective and preventive actions (capa) captures further investigation to address complaints related to crimp balloon tears.The capa identified a potential manufacturing factor which was correlated with an increase in reported complaints.However, since work order information was not provided, it could not be determined whether the crimp balloon tubing was related to one of the suspect lots and the manufacturing factor.The complaints were unable to be confirmed.Additionally, due to the unavailability of the device, it cannot be determined if a manufacturing nonconformance contributed to the reported events.No labeling or ifu/training inadequacies were identified.In this case, available information suggests that patient/procedural factors (valve alignment in a non-straight section) may have contributed to the complaint event.However, based on available information, a definite root cause cannot be determined at this time.No ifu/training manual inadequacies were identified and a review of complaint history revealed that the occurrence rate for the trend category did not exceed its december 2018 control limit.Therefore, no corrective/preventive actions are required at this time.The balloon torn issue and its associated risks have previously been assessed and documented in a product risk assessment.In addition, to address the trend in crimp balloon tear complaints, a capa captures further investigation and corrective action related to manufacturing.Per management discretion, a capa was initiated to include additional information in the ifu related to tension build-up in the device.

Manufacturer Narrative

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

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8166716
• MDR Text Key: 131304938
• Report Number: 2015691-2018-05300
• 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: 11/21/2018

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: Health Professional
• Device Model Number: 9600LDS29A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/23/2019; 07/23/2020
• Supplement Dates FDA Received: 01/28/2019; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR