MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM, 26MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9610TF26

Device Problems Material Fragmentation (1261); Inflation Problem (1310); Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by our (b)(4) affiliate, valve alignment was performed without difficulty.During valve deployment of a 26 mm sapien 3 valve in the aortic position, the commander delivery system balloon could not inflate.The sheath and delivery system were retrieved as a unit and a new sheath, commander, and valve were used.The same issue occurred with the second system, the balloon could not inflate during valve deployment.This second system was completely removed and a third system was opened and the procedure was successfully performed.Per post procedure discussion, it was thought that the event could have been caused by having performed valve alignment in a not straight section of the aorta and the valve could have perforated the commander balloon.The valve alignment of the third system was performed doing the valve alignment in a section more proximal to the femoral artery.This report is for the first delivery system used in this case.

Manufacturer Narrative

The commander delivery system was returned to edwards lifesciences for evaluation.Visual inspection revealed the following: valve received over inflation balloon, crimp balloon torn adjacent to inflation balloon/crimp balloon (i/c) bond, balloon wings bent, and gouges on flex tip.Functional testing was not performed due to the condition of the returned device (crimp balloon torn).Dimensional testing was performed on the double wall thickness of the crimp balloon and was found to be in within specification.Procedural cine was provided and reviewed and the following observations were made: valve alignment of the device is performed at a bend, heavy valve diving is observed, valve diving is seen as the valve was placed in the native annulus, valve appears to have moved proximally from the valve alignment marker after flex tip is retracted, and the flex tip is not against the valve to provide support during retrieval of the system.During balloon manufacturing, the balloon was 100% inspected for the following: working length, balloon diameter, proximal and distal leg ids, proximal leg od, and double wall thickness measurements.The balloon is 100% visually inspected for defects such as: witness lines, contamination, mechanical damage, deformation, crow¿s feet, fish eyes, gel spots and scratches.Ten balloons are sampled for burst testing and additional visual inspection.Upon the completion of crimp balloon molding and annealing, the crimp balloons are 100% dimensionally and visually inspected for the following: distal and proximal ids, single/double wall thickness, general appearance/gross defects (unaided eye visual inspection), foreign matter, impurity/contamination (under 8x magnification), and appearance of fish eye and gel spots.The flex tip od is inspected during the flex tip assembly and bonding process.The nose tip/guidewire shaft bond is visually inspected.The crimp balloon to inflation balloon laser bond is inspected for bubbles and gaps between components.The marker band is inspected to ensure the markers bands are completely showing after insertion into marker band placement tool and adequate adhesive coverage.The delivery system balloon undergoes 100% inspection for distorted/pinched folds and the balloon size is inspected.During spring coil installation each guidewire shaft is fully inserted into the marker band verification fixture and 100% visually inspected to determine if all marker bands are within specification when completely visible through the fixture windows.The balloon assembly is 100% visually inspected prior to laser bonding for any contamination.Prior and after the balloon pleat, fold and forming process, the balloon is 100% inspected for balloon size, contamination, fold lines and distorted/pinched folds.During final inspection the entire device from distal to proximal is visually inspected by both manufacturing and quality for damage, or missing components, and distorted/pinched folds.The commander delivery system is 100% leak tested and a visual inspection of the balloon catheter.During functional product verification (pv) testing, the delivery system is inspected for kinks, cracks, missing components, and missing small white marker band on balloon shaft (unaided eye).The fine adjust functionally is verified.The balloon burst pressure was tested.The lot met statistical requirements as it exceeded the acceptance criteria of a lower specification limit.Testing was performed for the inflation balloon/crimp balloon tensile force, for tensile force, and all met statistical requirements.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.The device history record (dhr) and lot review were reviewed and did not reveal any manufacturing related issues that would have contributed to this event.A review of edwards lifesciences risk management documentation was 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.The complaints for balloon torn and delivery system ¿ valve movement on balloon were confirmed through visual inspection and available imagery.A review of complaint history and manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.As no issues were noted during device prepping and de-airing, the device likely had no issues with the balloons out of box.As such, it is likely that the torn crimp balloon occurred during the procedure.A review of complaint history revealed that the potential root causes for tearing of the crimp balloon material proximal to the inflation balloon to crimp balloon bond have been previously identified and documented in a product risk assessment (pra) by edwards lifesciences.The pra identifies increased alignment forces experienced during the procedure as a possible root cause for the balloon tear.If the physician performed the valve alignment process at a bend or angle, it could result in increased forces being applied to the bond area.This may occur as performing valve alignment in a non-straight section of the aorta can cause the thv to unseat (non-coaxial placement of the thv in relation to the flex tip) from the flex tip and ¿dive¿ into the lumen of the flex tip.If the thv is unseated during valve alignment, it can result in higher than usual alignment forces, weakening and subsequently tearing the balloon material near the inflation balloon to crimp balloon bond.Under simulated conditions (tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces with valve diving.Review of the provided procedural imagery revealed that valve alignment was performed at a bend.In addition, valve diving can been seen in the images.The flex tip gouges noted during visual inspection are also indicative of valve diving and high alignment forces.Based on the available information, it is likely that the balloon tore during valve alignment.Once torn, the balloon can become more compressed distal to the valve, shifting the valve forward relative to the marker bands and making the valve appear to be aligned.However, retracting the flex catheter would have caused the balloon to un-compress and shift the valve proximally.This would give the appearance of the valve moving on the balloon.As a result, available information suggests the root cause for the reported complaint events may be attributed to patient and/or procedural factors.Per management discretion, the balloon torn issue and its associated risks have previously been documented and assessed in a product risk assessment (pra).In addition, to address the emerging trend in ic bond complaints, a capa is being updated.In addition, a pra and a capa were previously initiated to investigate and document the investigation of the valve movement on balloon issue and its associated risks.The complaints were confirmed.No manufacturing non-conformance was identified in the returned device.In this case, available information suggests that patient factors (tortuosity) and/or procedural factors (valve diving, balloon torn) may have contributed to the complaint event.No labeling or ifu/training inadequacies were identified.Review of complaint history revealed that the occurrence rate for the trend category valve movement on balloon did not exceed july 2018 control limits.No further actions are required at this time.Reference mfg.Report no.2015691-2018-03223.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM, 26MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7754325
• MDR Text Key: 116711308
• Report Number: 2015691-2018-03222
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2018

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 Expiration Date: 01/18/2020
• Device Model Number: 9610TF26
• Device Lot Number: 61239697
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 10/04/2018; 07/23/2020
• Supplement Dates FDA Received: 10/06/2018; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1