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

Model Number	9600LDS26A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
During a transfemoral tavr procedure, a 26mm sapien 3 valve was deployed in the aortic annulus.Post deployment, moderate paravalvular leak (pvl) was observed.The valve was post dilated with an additional 2cc of fluid, reducing the pvl to none-trace.Satisfied with the valve deployment, the commander delivery system was withdrawn.During withdrawal, the delivery system became stuck in the esheath just below the skin.Additional force was used during the attempt to withdrawal the delivery system, resulting in the separation of the balloon/nose cone/hypotube.The delivery system and separated balloon/nose cone remained fully contained inside the sheath.The esheath, delivery system and separated balloon/nose cone were removed as a unit.Following the withdrawal of the devices, a liner dissection was noted in the proximal femoral artery.A balloon was inflated to resolve the dissection.The valve remains implanted in the patient.At the time of the report, the patient was in stable condition.
Additional Manufacturer Narrative
The commander delivery system and esheath were returned to edwards lifesciences for evaluation.Visual inspection revealed the inflation balloon to the crimp balloon was torn.The inflation balloon wings were flared out.The sheath distal tip was opened as designed, with minor damage on the tip.The inflation balloon was bunched, and the distal tip had minor stretching.Review of the provided case imagery revealed inflation balloon bunching.Functional testing and dimensional analysis could not be performed due to the condition of the returned device.Device history review (dhr) was performed for the components most relevant to the reported event.The work orders did not reveal any manufacturing non-conformances that could have contributed to the reported event.Lot history review revealed no other complaints related to the complaint codes.Complaint history review from february 2020 to january 2021 for the commander delivery system (all models and sizes) revealed other reported events for similar events and codes.Available information suggests that procedural factors (withdrawal of burst/torn balloon, excessive force, non-coaxial withdrawal) and patient factors (calcification/tortuosity) may have contributed to the complaint events.The instructions for use (ifu), device preparation manual, and procedural training manual were reviewed for instructions/guidance on device preparation/usage.The operator is instructed to use caution in tortuous or calcified vessels that would prevent safe entry of the introducer set.Additionally, push for can vary due to angle of insertion, thv size, vessel diameter, tortuosity, and degree of calcification.If push force is high, the operator is instructed to slightly pull back the sheath while advancing the delivery system 1-2cm.Delivery system removal: completely unflex the delivery system, ensure the flex tip is still over the triple marker, ensure balloon lock is locked, ensure the balloon is completely deflated, pull the entire delivery system through the sheath, maintain guidewire position in the aorta.Caution: patient injury could occur if the delivery system is not completely unflexed prior to removal.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.In this case, the complaints were able to be confirmed based on the evaluation of the returned device.However, a manufacturing nonconformances was not identified.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.As per the complaint description, 'upon pulling out the commander delivery system, the delivery system became stuck in the esheath just below the skin'.Also, balloon was separate and inflation balloon wings were flared out and that could further lead to difficulty retrieving the delivery system.Patient had tortuosity and calcification present.Tortuosity and calcification in the access vessel can create non-coaxial withdrawal angles, resulting in the distal end of the delivery system catching onto the sheath tip.Potential root causes for separation 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).That the inflation balloon was able to be fully inflated during valve deployment suggests that the crimp balloon tore afterwards (i.E.During device retrieval).Factors such as residual fluid in the inflation balloon, or vessel calcification/tortuosity may cause non-coaxial retrieval of the delivery system into the sheath.This can result in an altered balloon profile that is not suitable for retrieval into the sheath tip, leading to withdrawal difficulty.Additionally, complaint notes indicated that there was mild tortuosity and calcification present.In this case, the delivery system withdrawal difficulty and balloon torn were likely due to calcification and tortuosity in access vessels, which could potentially impact coaxiality with the sheath, thereby potentially constraining retrieval of the delivery system.So, if excessive force was applied, it could lead to balloon torn.Although a definite root cause was not able to be confirmed, the available information suggests in addition to procedural factors (excessive device manipulation), patient factors (vessel tortuosity) may have contributed to the withdraw difficulty and subsequent torn balloon.As a result of the balloon torn, the balloon's altered profile and flared balloon legs likely led to difficulties encountered with withdrawing the delivery system into the sheath.The altered balloon profile and distal portion of delivery system could have got caught in the sheath tip.Subsequently, this may have required excessive manipulation of the devices to overcome the withdrawal difficulties, which may have resulted in separation of the components (distal nose tip).The reported withdrawal difficulties and manipulation of the devices, in addition to the vessel characteristics may have contributed to the femoral artery dissection.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.There were no ifu, labeling, or training manual inadequacies, and no manufacturing non-conformances were identified during this evaluation.Therefore, no corrective or preventative actions are required at this time.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11301718
• Report Number: 2015691-2021-01178
• Device Sequence Number: 14289593
• Product Code: NPT
• UDI-Device Identifier: 00690103193954
• UDI-Public: (01)00690103193954(17)221209(10)63566165
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: 9600LDS26A
• Device Lot Number: 63566165
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0835-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR