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

Model Number 9600LDS26A

Device Problems Hole In Material (1293); Leak/Splash (1354); Difficult To Position (1467); Difficult to Remove (1528)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is underway.

Event Description

As reported by the field clinical specialist, during valve alignment a ¿pop/snap sound¿ was heard from the 26mm commander delivery system.Fluoroscopy was performed and contrast was seen in the distal tip of the balloon.The system was dialed back and the procedure was continued.After navigating around the arch and through the annulus, the 26mm sapien 3 valve ¿shifted up the balloon,¿ aortic.Everything was pulled back and alignment was performed again.The same event occurred with the valve shifting up the balloon aortic.It was decided to try to deploy the valve at a slow pace, however, the balloon did not inflate as there was a ¿pinhole¿ in the balloon.During the withdrawal, the delivery system balloon (fluid inside) bunched at the end distal tip of the esheath and was caught on the radiopaque marker on the esheath.¿the balloon pulled the radiopaque marker inside the esheath.It was confirmed that the radiopaque marker was inside the balloon material and not inside the patient (still attached).¿ at this point the valve and balloon were about 2-3 inches inside the esheath.Everything was removed as one unit (esheath; commander; valve).A new sheath, valve and delivery system were used to complete the procedure successfully.

Manufacturer Narrative

The device was returned for evaluation.The delivery system was returned partially inserted through the esheath and fully inserted through the full loader assembly.The valve (undeployed, still on inflation balloon) was withdrawn into the esheath.The returned delivery system was visually inspected for abnormalities.The following were observed: bend on balloon shaft due to return packaging, valve strut bent approximately 90 degrees, distal inflation balloon bunched, crimp balloon torn proximal to i/c bond, severe flex tip gouges, minor compression on flex shaft just proximal to flex tip, x-ray of the returned delivery system shows that the collet assembly appears normal, x-ray of the returned delivery system shows no abnormality to the pull wire a provided photograph and 3mensio imagery of the patient anatomy were reviewed and the following observations were made: pinhole reported on the distal shoulder of the inflation balloon, mild tortuosity and calcification of the vasculature, curves in descending aorta, luminal diameter, bilaterally, greater than 9.0 mm crimp balloon double wall thickness measurements were taken to ensure that the thickness of the material was within specification.A thin balloon could contribute to the observed balloon tear and could be indicative of a manufacturing nonconformance.The crimp balloon double wall thickness was found to be within specification.Functional testing was performed and able to use full fine adjust with no recoil observed.Due to the condition of the returned device (balloon torn), no functional testing was able to be performed to inflate the balloon, pinhole could not be verified through inflation of the balloon or by visual inspection.A device history review was performed and did not reveal any issues that could have contributed to this complaint event.A lot history review was performed and revealed other complaints relating to ¿handle ¿ fine adjust difficulty¿ and ¿delivery system ¿ valve movement on balloon¿.No other complaints relating to balloon ¿ torn and delivery system ¿ withdrawal difficulty ¿ valve, through sheath were found.A review of the complaint history revealed that the occurrence rate did not exceed the may 2018 control limit for the trend category of ¿valve movement on balloon¿ ¿damaged¿ and ¿withdrawal difficulty¿.A review of the complaint history revealed that the occurrence rate exceeded the may 2018 control limit for the trend category of ¿fine adjust difficulty¿.The complaint occurrence rate exceeded the may 2018 control limit for the ¿fine adjust difficulty¿ trend category; however, no manufacturing non-conformance have been identified.Additionally, a review of past complaints revealed that no manufacturing nonconformance or ifu / training deficiencies have been identified at this time no instructions for use (ifu) or training deficiencies were identified.Manufacture- inspections during the manufacturing process and testing performed during the product verification process make it unlikely that a manufacturing nonconformance contributed to the reported complaints.The complaints for handle ¿ fine adjust difficulty, delivery system ¿ valve movement on balloon, balloon ¿ torn, and delivery system ¿ withdrawal difficulty ¿ valve, through sheath were confirmed.A review of complaint history revealed that potential root causes for tearing of the crimp balloon material proximal to the inflation balloon to crimp balloon bond have been identified and documented in a product risk assessment investigation.Per device training materials, valve alignment should be done in a straight section.If the physician performed the valve alignment process in a tortuous anatomy (as noted during imagery review, the patient had mildly tortuous anatomy and curves in the aorta), it may have resulted in increased forces being applied to the crimp balloon.This may occur as performing valve alignment at a bend or angle can cause the  valve 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 valve is unseated during alignment, it can result in higher than usual valve alignment forces which may result in a crimp balloon tear.It should be noted that severe gouges were observed on the flex tip of the returned device, which are indicative of high valve alignment forces and valve diving.Compression of the flex shaft also suggest high 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 material failure in the area in question.The popping / snapping sound that the operators reported hearing, during valve alignment, may have been the i/c bond separating due to high alignment forces.These high forces would have contributed to difficulty with fine adjust as well.As such, it is likely that the balloon tore during valve alignment.Once the balloon tore, attempts to complete valve alignment would have bunched the balloon 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 when viewed under fluoroscopy.Furthermore, the bent strut on the valve is indicative of withdrawal difficulty of the thv through the sheath.If the valve was not centered on the flex tip prior to retrieval into the sheath, the valve struts can get caught on the sheath tip.Having a valve strut bent at nearly 90 degrees supports that the valve was likely caught on the sheath tip during retrieval.Therefore, available information suggests that patient/procedural factors (valve alignment in tortuous vasculature; withdrawal of torn balloon/valve) may have contributed to the reported event.However, a definite root cause is unable to be determined.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 ¿handle ¿ fine adjust difficulty¿, ¿delivery system ¿ valve movement on balloon¿, ¿balloon ¿ torn¿, and ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿ were confirmed.Available information suggests that patient and / or procedural factors may have contributed to the complaints.No labeling or ifu inadequacies were identified and review of complaint history revealed that the occurrence rate did not exceed the may 2018 control limits for the trend categories ¿withdrawal difficulty,¿ ¿valve movement on balloon,¿ and ¿damaged.¿ therefore, no corrective or preventative action is required at this time for the associated trend categories.The trend category for ¿fine adjust difficulty¿ occurrence rate did exceed the may 2018 control limits.However, no manufacturing non-conformances were identified in the product evaluation, and no labeling, training, or ifu deficiencies were identified.Therefore, no preventative or corrective actions are required.

Manufacturer Narrative

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

• Brand Name: EDWARDS COMMANDER DELIVERY
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7630061
• MDR Text Key: 112572839
• Report Number: 2015691-2018-02408
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 9600LDS26A
• Device Catalogue Number: N/A
• Device Lot Number: 61171845
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR