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

Model Number 9600LDS29A

Device Problems Fracture (1260); Difficult to Remove (1528); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 09/21/2022

Event Type  Death  

Manufacturer Narrative

The investigation is ongoing.A voluntary medsun was received mw5112407.

Event Description

Per the field clinical specialist (fcs), after the successful insertion of the esheath plus via the left subclavian artery, the 29mm sapien 3 valve on the commander delivery system (ds) was inserted in the usual fashion.As the prosthesis reached the ostia of the left subclavian artery (lsc) and ascending aorta, resistance was noted in the system.The implanters were able to advance the system into the ascending aorta with manipulation of the system.At this time, valve alignment was attempted in the usual fashion.It was noted at this time that the balloon would not move despite the proper use of the fine adjustment wheel.The team decided to reposition the entire ds and continued to attempt the completion of valve alignment.Once the balloon was in the proper position, the team moved forward with pulling the pusher off the system per standard protocol.However, each time the implanters pulled the pusher off the balloon and prosthesis, the balloon would move forward off the prosthesis.This maneuver was completed several more times until the implanters were satisfied with the balloon position within the prosthesis.Under rapid pacing, the implanter attempted to deploy the valve, however, the balloon was noted to be ruptured and the prosthesis was not deployed.At this time, the decision was made to remove the entire system and valve through the esheath and to attempt the implant of a new valve immediately.While removing the unit, the system was unable to be obtained in the sheath for removal.The distal end of the ds with the prosthesis in place on the ruptured balloon, split into two parts injuring the lsc artery, and requiring both surgical and catheter-based interventions.No further tavr intervention was performed.Per voluntary medsun received, after the devices were removed, the patient became hypotensive, requiring intermittent chest compressions and intervention to stabilize the patient's condition.The patient was stabilized and transferred to the icu where he subsequently passed away.

Manufacturer Narrative

Correction to h6; component code, device code, type of investigation, investigation findings, investigation conclusion.Update to a2 and b2 for the date of death.The commander delivery system (ds) was not returned for evaluation.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.Imagery was provided and the following was observed: the nose tip with valve was partially crimped over the inflation balloon, and there was a balloon tear at the inflation/crimp balloon bond with the guidewire lumen cut and separated from the rest of the ds.Patient tissue was observed on the proximal shoulder of the inflation balloon.The proximal portion of the ds was observed with torn crimp balloon side of the inflation/crimp balloon bond.The ds was within the patient's left subclavian artery and aorta, and the flip tip was observed between the triple markers and the proximal end of the valve.Tortuosity was seen in the patient's vasculature with undersized access vessels.A video was provided that showed the valve in the patient's annulus although not aligned between the valve alignment markers.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint code.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u, device preparation manual, procedural training manual and the subclavian supplementary training manual.Based on this review, no ifu/training deficiencies were identified.During manufacturing, the commander delivery system is both visually inspected and tested several times throughout the process.During the final inspection, the device undergoes visual and functional inspections.Additionally, the delivery system is tested and inspected on sample devices from each lot during product verification (pv) testing.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.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 valve alignment difficulty, balloon tore, valve moves on balloon, withdrawal difficulty, and system components separating during use were confirmed based on the evaluation of returned imagery.No manufacturing non-conformances were identified during the engineering evaluation.A review of the dhr, lot history, complaint history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.As reported, "it was noted at this time, however, that the balloon would not move despite proper use of the fine adjustment wheel.The team decided to reposition the entire ds and continued to attempt the completion of valve alignment.Once the balloon was in the proper position, the team moved forward with pulling the pusher off the system per standard protocol.However, each time the implanters pulled the pusher off the balloon and prosthesis, the balloon would move forward off the prosthesis." it is possible that tension was introduced onto the delivery system and resulted in the observed compression on the flex shaft.The exact cause of the tension is unknown.However, it is possible that valve alignment was performed in a tortuous (non-straight section) vasculature, as observed in 3mensio of the patient's subclavian anatomy.This can cause the valve to become unseated (non-coaxial placement of valve in relation to the flex tip) and "dive"into the flex tip.If the thv is unseated from the flex tip during alignment, it can result in higher-than-normal alignment forces creating high tension in the system which can consequentially lead to the reported valve alignment difficulties.Under simulated conditions (simulated tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces.The study revealed that performing valve alignment in a curvature appears to increase the possibility of "diving" (thv become unseated from the flex tip), which in turn increases valve alignment force.Higher alignment force appeared to have a higher likelihood of occurrence at tighter radii.As reported, "each time the implanters pulled the pusher off the balloon and prosthesis, the balloon would move forward off the prosthesis." potential root causes for valve movement on balloon have been identified and documented in product risk assessment (pra).Attempting to track the delivery system through tortuous patient anatomy as observed can result in built-up tension.Similarly, performing valve alignment in a non-straight section of the anatomy can also result in tension."under rapid pacing, the implanter attempted to deploy the valve, however, the balloon was noted to be ruptured and the prosthesis was not deployed." evaluation of provided imagery from the field revealed a torn i/c bond.Potential root causes for the separation of the inflation balloon to crimp balloon bond have been identified and documented in pra.As identified in the pra, high forces on the system during valve alignment may result in crimp balloon tearing prior to thv deployment.As difficulty performing valve alignment was reported, it is possible that increased forces of performing valve alignment may have weakened the balloon and caused the balloon to tear and subsequent inability to deploy the thv."while removing the unit, the system was unable to be obtained in the esheath for removal.The distal end of the ds with the prosthesis in place on the ruptured balloon, split into two parts injuring the lsc artery, and requiring both surgical and catheter-based interventions." in the 3mensio provided by the field, tortuous access vasculature was observed.Tortuous patient anatomy could result in non-coaxial angles of withdrawal during system retrieval.It is possible that the non-coaxial withdrawal configuration may have resulted in the crimped thv interacting with patient vasculature and causing the reported withdrawal difficulty.Excessive force applied to overcome any resistance during withdrawal of the delivery system through vasculature could have caused the distal tip separation observed.Additionally, it is possible that the device was cut as part of the surgical intervention to remove the device.Imagery provided by the field shows a clean separation of the guidewire lumen that was likely due to the lumen being cut, resulting in a complete separation of the distal portion of the delivery system including inflation balloon, nose tip, and crimped thv.In this case, available information suggests that patient (tortuosity) and/or procedural factors (valve alignment in a non-straight section, excessive manipulation, non-coaxial withdrawal, withdrawal of a torn balloon/crimped valve) may have contributed to the reported event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.The complaints for (balloon torn) separation of the inflation balloon to crimp balloon bond and valve movement on the balloon have been identified and documented in a product risk assessment (pra) and capa.

• Brand Name: COMMANDER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492503865
• MDR Report Key: 15594300
• MDR Text Key: 301630259
• Report Number: 2015691-2022-08554
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240627(10)64457104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• Device Catalogue Number: 9600LDS29A
• Device Lot Number: 64457104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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
• Patient Age: 77 YR
• Patient Sex: Male