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

Model Number 9600LDS23

Device Problems Crack (1135); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 10/03/2019

Event Type  Death  

Manufacturer Narrative

Thv tvt registry.Udi (b)(4).Investigation is ongoing.

Event Description

As reported by field clinical specialist (fcs), the patient had a calcified and tortuous aorta.While advancing the sapien 3 valve on the commander delivery system through the esheath, the thoracic aorta was dissected.There was no edwards device malfunction.An occlusion balloon was inserted.The team attempted to pull the delivery system and valve back through the sheath, but the valve got stuck on the sheath.The team tried to twist the balloon and they "cracked" the catheter, thus they were unable to deploy the valve before removing the delivery system.The team was planning to leave the devices in, and use surgical intervention to remove it once the dissection was fixed.However, the patient "spiraled", bled out and passed away.Patient died on the table due to a dissection on the thoracic aorta.

Manufacturer Narrative

Per the instructions for use (ifu) cardiovascular injury, such as perforation or dissection of vessels, ventricle, myocardium or valvular structures, is a known potential complication associated with the tavr procedure.There are numerous possible mechanisms by which an aortic dissection can develop during tavr: stiff wire interaction in the ascending aorta, catheter valve injury to the aortic wall by creating an intimal disruption, valve retraction to expose the balloon in balloon-expandable systems, balloon valvuloplasty injury, post-dilation balloon interaction with the aorta, and/or when excessive force is used.Physicians are extensively trained by edwards before they are qualified to use the sapien 3 transcatheter heart valve (thv).The thv training manuals provide guidance to facilitate safe crossing of the native valve, including camera projections, handling during advancement, and troubleshooting techniques if difficulty is encountered.As stated, excessive force should not be used when the device has difficulty crossing the stenotic valve.Adding tension to the wire, pulling back the system to re-orient the valve, as needed, and torqueing of the flex catheter may be helpful in solving the problem.In this case, the cause of the thoracic aorta dissection cannot be confirmed; however, per report it was not related to an edwards device malfunction.It is possible that patient factors (calcified and tortuous aorta) and/or procedural factors (device manipulation) may have contributed to the event.The device was not returned for evaluation as it was discarded by the site.No imagery was provided for review.The related work orders did not reveal any manufacturing related issues that could have contributed to the complaint.A lot history review revealed no other similar complaints.A review of complaint history from november 2018 ¿ october 2019 revealed additional returned complaints for the commander delivery system (all models and sizes) for the complaint codes.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.No manufacturing non-conformances that would have contributed to the complaints were identified.Available information suggested that the similar events could be attributed to patient/procedural factors.The review of complaint data found that the complaint rate did not exceed the october 2019 control limit for the related trend categories.During manufacturing the balloon undergoes multiple 100% inspections.Additionally, the lot underwent product verification testing as a requirement for lot release.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.The delivery system instructions for use (ifu), system preparation manual, and procedural training manual were reviewed for instructions or guidance for proper use of the commander delivery system.No ifu/ training deficiencies were identified.The complaints were unable to be confirmed as the device was not returned and relevant imagery was not provided.Visual inspection and dimensional or functional testing were unable to be performed with no returned device.Therefore, the presence of a manufacturing non-conformance was unable to be determined.Review of the dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the reported event.Review of the ifu/training manuals revealed no deficiencies.If there was non-coaxial retrieval of the delivery system with crimped valve into the sheath, it is possible that the valve struts caught on the sheath during retrieval attempts.Non-coaxiality between the devices could have occurred from a tortuous patient anatomy or interaction with calcification.However, no patient vessel characteristics were provided.The complaint description states that ¿the team tried to twist the balloon and they ¿cracked¿ the catheter¿.It is likely that the additional force and torqueing of the system during retrieval attempts caused damage to the delivery system particularly on the crimp balloon.Potential root causes for balloon torn have been identified and documented in a previous product risk assessment (pra) by edwards lifesciences and includes balloon tears that occur from withdrawal difficulties.While a definitive root cause is unable to be determined, based on available information it is likely that procedural factors (non-coaxial retrieval of delivery system with crimped valve; excessive manipulation) contributed to the balloon tear.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.Since no product non-conformances or labeling/ifu/training deficiencies were confirmed and the complaint rate did not exceed the october 2019 control limit for the applicable complaint trend categories, neither a pra escalation/assessment, nor corrective or preventative action is required.

Event Description

Hold cm 2.21.23.

Manufacturer Narrative

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

• 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: 9240668
• MDR Text Key: 163813517
• Report Number: 2015691-2019-03957
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Model Number: 9600LDS23
• Device Lot Number: 62083326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 93 YR