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

Model Number 9610TF26

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problems Death (1802); Rupture (2208)

Event Date 02/14/2018

Event Type  Death  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported by the edwards affiliate in (b)(4), during a transfemoral tavr procedure in the aortic position, the delivery system would not advance to the arch.As the physicians exerted more than usual amount of forward pressure to the delivery system, the shaft suddenly advanced forward through the esheath because the delivery system and wire had kinked distal to the end of the esheath.The catheter exited the aorta laterally through the now ruptured aaa.The sudden forward movement was the bending of the delivery system itself.The patient rapidly lost blood pressure and died on the table during the procedure despite resuscitative efforts.The esheath was inserted without issue.The delivery system was advanced through the esheath without issue and the balloon was aligned in the stent frame without issue.The delivery system was then advanced to the arch, where it became difficult to advance further.The physician attempted partial flex, full flex, no flex, catheter rotations, and a 1-2cc of distal balloon tip inflation to get the delivery system to advance around the arch, but made no progress.The aortic arch anatomy was grossly normal according to the physicians and not overly tortuous or calcified, but still would not allow the delivery system to advance easily.A second physician scrubbed in and also attempted to advance the system without success, while ¿rearward and forward tension and pressure were applied to the wire and system.¿ the physicians then exerted more than the usual amount of forward pressure to the delivery system, and while the tip did not advance the handle and shaft suddenly advanced forward through the esheath as the delivery system and wire had kinked distal to the end of the esheath.The catheter exited the aorta laterally through the now ruptured aaa.The sudden forward movement appeared to be bending of the delivery system itself.The patient rapidly lost blood pressure and died on the table during the procedure despite resuscitative efforts.The annular diameter measured 24.5mm.The patient had mild-moderate annular calcification.The access diameter measured 7-8mm and was mildly calcified and moderately tortuous.The patient¿s aaa was just above iliac joining common 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.Per the ifu, the safety and effectiveness have not been established for patients with significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding, or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe ¿unfolding¿ and tortuosity of the thoracic aorta.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 during valve alignment and if diving of the valve is observed.As stated, valve alignment is advised to be performed in a straight section of the aorta and excessive force should not be used when the device has difficulty crossing the stenotic valve.In this case, severe tortuosity of aorta with very sharp angles, pre-existing aaa and excessive force applied when advancing the devices caused or contributed to the patient¿s abdominal aortic rupture.The delivery system was not returned to edwards lifesciences for evaluation as it was discarded by the facility.No relevant device photographs, videos or imagery of the event were provided.During manufacturing, the flex catheter undergoes multiple 100% inspections.The delivery system are inspected for mechanical damage, sharp/rough edges, exposed/visible metal and braid, and delamination.Per procedure, the flex angle and gap distance are tested with a guidewire inserted through the delivery system.Assembled devices undergo 100% final inspection by manufacturing and quality.The entire device is visually inspected for missing components, damage (e.G.Kinks, cuts), and contamination.The flex shaft is visually inspected for kinks, bends, cracks, deep scratches, flash, exposed metal, and sharp edges of the braided section.In addition, each lot is required to undergo product verification tests using five (5) samples.All samples selected from each lot must pass the following tests pertaining to the complaint events: visual inspection to ensure device is free from physical defects such as kinks and cracks, and loose or missing components prior to functional tests.Kink radius testing is performed on each sample.Samples are rejected for kinks or cracks.During torque testing, the delivery system is rotated one full turn and then rotated a full turn in the opposite direction.The delivery system is then tracked and flexed over an aortic arch of a glass model.These inspections during the manufacturing process support that it is unlikely a manufacturing non-conformance contributed to the complaint events.A device history records (dhr) review performed revealed no issues that would have contributed to the complaint events.Lot history review of the work order revealed no complaints relating to ¿delivery system ¿ tracking difficulty¿ and one complaint relating to ¿delivery system ¿ kinked, bent.¿ a review of complaint history from march 2017 to (b)(4) 2018 for the edwards commander delivery system (all models and sizes) revealed 2 returned complaints for ¿delivery system ¿ tracking difficulty¿.Both returned are pending engineering evaluation.A review of the complaint history revealed that the occurrence rate did not exceed the (b)(4) 2018 control limit for the trend category of ¿tracking difficulty.¿ a review of complaint history from march 2018 to (b)(4) 2018 for the edwards commander delivery system (all models and sizes) revealed 17 returned complaints for ¿delivery system ¿ kinked, bent¿.In all cases, the complaints were confirmed, but no manufacturing non-conformances were found.Available information suggested that the damages occurred either due to during device preparation and/or shipping and handling, procedural factors (device handling) or patient factors which contributed to the reported events.No labeling or ifu inadequacies were identified and review of complaint history revealed that the occurrence rates did not exceeded control limits for the applicable trend category.No corrective or preventative action was required.A review of the complaint history revealed that the occurrence rate did not exceed the (b)(4) 2018 control limit for the trend category of ¿kinked, bent¿.The ifu and procedural training manuals were reviewed for instructions related to the complaint events.No ifu/training deficiencies were identified.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 the delivery system and relevant imagery, photographs or videos were not provided, the complaints for ¿delivery system ¿ tracking difficulty¿ and ¿delivery system ¿ kinked, bent¿ were unable to be confirmed.Due to the unavailability of the relevant device, engineering was unable to perform any visual, functional or dimensional analysis.As a result, a manufacturing non-conformance was unable to be determined.A review of dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance would have contributed to the complaint events.Additionally, a review of manufacturing mitigations supports that the delivery system has proper inspections in place to detect issues related to the reported complaints.Review of case notes revealed that the patient¿s access vessel was mildly calcified and moderately tortuous.Both patient factors can create a difficult path for the delivery system to go through while advancing through patient vasculature and can contribute to a kink or bend in the devices.Additionally, the training manual states that during tracking ¿to prevent kinking of the delivery system, do not torque the handle while rotating the flex wheel.¿ per the complaint description, ¿the physician attempted partial flex, full flex, no flex, [and] catheter rotations¿¿ and the physicians ¿exerted more than the usual amount of forward pressure to the delivery system¿ while advancing the delivery system.Excessive force and manipulation of the device while advancing over the aortic arch may have contributed to the reported tracking difficulty and delivery system kink/bend.It is likely that the complaint events are related.Available information suggests that patient (calcification/tortuosity) and/or procedural (excessive force/device manipulation) factors may have contributed to the reported complaint events.However, without the device, cine, or imagery there is insufficient information to determine a definitive root cause at this time.No manufacturing or ifu/training inadequacies were identified.Available information suggests that patient (calcification/tortuosity) and/or procedural (excessive force/device manipulation) factors may have contributed to the reported complaint events.Review of complaint history revealed that the occurrence rates for (b)(4) 2018 did not exceed the control limits for the applicable trend categories.Therefore, neither a pra nor corrective/preventative action was required.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 7310648
• MDR Text Key: 101415691
• Report Number: 2015691-2018-00745
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/21/2019
• Device Model Number: 9610TF26
• Device Lot Number: 60956403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 79 YR