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

Model Number 9610TF23

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205); Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(6), during a left transvenous valve in valve (23 mm sapien 3 in 23 mm medtronic freestyle surgical valve) tvr procedure in the pulmonic position, once the valve was aligned in a straight section, a few attempts were required to successfully position the delivery catheter and the sapien 3 valve within the surgical valve.During inflation, ¿no balloon expansion, contrast or valve expansion¿ was noted on continuous fluoro.The second operator indicated the inflation device had ¿bottomed out¿.There was no obvious reason for the contrast mix not entering the delivery balloon as the 3-way tap was open to the delivery system and no leakage of mix could be seen.On closer inspection of the images, the proximal end of the balloon could be visualized.The decision was made to retrieve the valve and the delivery system due to a possible balloon perforation.The system was brought back to iliac and vascular assistance was sought.Full removal of system and valve was done under vascular cut down.A small hole in balloon could be seen on the balloon once it was removed.No valve was inserted.The decision was made to reassess the procedure at a later date.The patient was hemodynamically stable throughout the procedure.It is perceived that a pin hole in the delivery system balloon had possibly occurred during valve alignment.It was confirmed that no tools had been used to remove the balloon cover and the plastic cover was moved off the balloon to peel away.

Manufacturer Narrative

The delivery system was returned inserted through the sheath and loader with a stopcock and atrion attached.The valve was returned crimped in a shelf jar.The returned delivery system was visually inspected for abnormalities.The following were observed: a pinhole observed near distal working length of the inflation balloon.No other abnormalities observed on nose tip or anywhere else on the delivery system.The double wall thickness of the inflation balloon was taken as a measurement out of specification could be indicative of a manufacturing non-conformance.Due to the location of the pinhole (near tapered location of balloon), only the measurement proximal to the pinhole was taken.Measurements met specification.The delivery system was fully flexed with no abnormalities observed.When the balloon as fully inflated, a pinhole was observed on the inflation balloon.Imagery for the reported event was provided.A photograph of the used device was provided.The balloon is seen uninflated and fully inflated.A pinhole leak is observed while the balloon is inflated.Cine imagery shows the delivery system and sapien 3 aligned within the stent.Tortuosity is present as a sharp bend is observed on the delivery system.A device history review (dhr) was performed for the components that are the most relevant to the complaint event.The work orders above did not reveal any issues that could have contributed to this complaint event.A lot history review was performed and revealed no other complaint relating to ¿delivery system ¿ difficulty crossing prosthetic valve¿ or ¿balloon ¿ leakage¿.A review of the complaint history from (b)(6) 2017 to (b)(6) 2018 for edwards commander delivery system (for all models and sizes) revealed other returned complaints.No other commander delivery systems were returned for ¿delivery system ¿ difficulty crossing prosthetic valve.¿ a review of the complaint history revealed that the occurrence rate exceeded the (b)(6) 2018 control limit for the trend category of ¿difficulty crossing¿.Although the occurrence rate exceeded the september 2018 complaint trending control limit for the category ¿difficulty crossing¿, no manufacturing non-conformances were identified.Additionally, a review of complaints and available information revealed that no product non-conformances or ifu/training manual deficiencies have been identified in previous investigations.As such, a product risk assessment (pra) escalation is not required.No manufacturing nonconformances or ifu/training manual deficiencies have been identified in the investigations.A review of the complaint history revealed that the occurrence rate did not exceed the september 2018 control limit for the trend category of ¿leakage¿.Since a product non-conformance was not confirmed in the returned complaint sample, and the occurrence rate did not exceed the complaint control limits, a product risk assessment (pra) is not required.No instructions for use (ifu) or training deficiencies were identified.During the manufacturing process, the entire delivery system (including the crimp balloon and inflation balloon) is visually inspected and tested several times.All lots are tested and can only be released if the product verification samples pulled from each lot pass all required tests.All samples passed pv testing.Inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the complaint event.Delivery system ¿ difficulty crossing prosthetic valve the complaint for ¿delivery system ¿ difficulty crossing prosthetic valve¿ was unable to be confirmed.Functional testing and visual inspection of the returned complaint device did not reveal a manufacturing non-conformance.Review of available information (complaint history, lot history, and dhr review) was unable to identify any evidence of manufacturing non-conformances.A review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the complaint event.It should be noted that the sapien3 is not approved for use in the pulmonic position or for valve in valve deployment in australia.Review of the provided imagery shows that tortuosity was present, as evidenced by the sharp bend in the delivery system.The present tortuosity can create a challenging pathway for aligning the delivery system into the stent, and can result in the reported difficulty.A definite root cause cannot be determined at this time, but available information suggests that patient factors (tortuosity) and/or procedural factors (off-label use of device) may have contributed to the complaint event.Balloon - leakage the complaint for ¿balloon ¿ leakage¿ was confirmed.Functional testing and visual inspection of the returned complaint device shows a pinhole on the distal tapered section of the inflation balloon.Review of available information (complaint history, lot history, and dhr review) was unable to identify any evidence of manufacturing nonconformances.A review of manufacturing mitigations supports that the balloon and delivery system have proper inspections in place to detect issues related to the complaint event.As there was no difficulty reported with de-airing the device, the pinhole was likely not present out of the box.The provided imagery shows the presence of tortuosity as evidenced by the sharp bend in the delivery system.The complaint description also states that ¿a few attempts were required to successfully position the delivery catheter and the valve within the stent.¿ it is possible that the combination of tortuosity and the multiple attempts to position the valve in the stent may have caused the balloon to catch on the stent resulting in the pinhole.It should be noted that the sapien3 is not approved for use in the pulmonic position or for valve in valve deployment in australia.A definite root cause cannot be determined at this time, but available information suggests that patient factors (tortuosity) and/or procedural factors (excessive device manipulation during alignment in stent/off-label use of device) may have contributed to the complaint event.As off-label use is not considered in fmeas, fmea assessment was not completed.Delivery system ¿ difficulty crossing prosthetic valve balloon - leakage since no manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified, no corrective/preventative actions are required.Delivery system ¿ difficulty crossing prosthetic valve the complaint for ¿delivery system ¿ difficulty crossing prosthetic valve¿ was unable to be confirmed.No manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified.A definite root cause cannot be determined at this time, but available information suggests that patient factors (tortuosity) and/or procedural factors (off-label use of device) may have contributed to the complaint event.Review of complaint history revealed that the occurrence rate for the applicable trend category exceeded the (b)(6) 2018 control limit.Balloon - leakage the complaint for ¿balloon ¿ leakage¿ was confirmed.A definite root cause cannot be determined at this time, but available information suggests that patient factors (tortuosity) and/or procedural factors (excessive device manipulation during alignment in stent/off-label use of device) may have contributed to the complaint event.Review of complaint history revealed that the occurrence rate for the applicable trend category did not exceed the (b)(6) 2018 control limit.Since no manufacturing non-conformances were confirmed and no ifu/training deficiencies were identified, no corrective/preventative actions are required at this time.

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: 7900288
• MDR Text Key: 121439079
• Report Number: 2015691-2018-03904
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2020
• Device Model Number: 9610TF23
• Device Lot Number: 61236080
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR