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

Model Number 9750CM26A

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device has not been returned.

Event Description

During deployment of a 26 mm sapien 3 ultra valve in the aortic position via transfemoral approach, the balloon ruptured when the valve was 90-100% deployed.During removal of the ruptured balloon and nose cone was retracted to tip of esheath and both were attempted to remove as one unit.The ruptured balloon & nose cone became caught on the distal end of right iliac stent.The commander delivery system was removed, however, the nose cone with part of the ruptured balloon detached.An attempt to snare the commander nose cone from the right side with no success.Non-edwards esheath inserted in the contralateral side to attempt to snare commander nose cone/sheared balloon.Several snares were attempted with no success.The nose cone & ruptured balloon was ultimately snared from right side.The right common iliac stent came out during removal.New right iliac stent deployed with no complications.Tee revealed mild-mod pvl, post dilation with 26mm non-edwards balloon resulting in mild pvl.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the device evaluation.The commander delivery system was returned and revealed inflation balloon burst, distal tip is separated, no missing balloon pieces, balloon spring is stretched out and separated and adhesive present on distal portion of gwl.Imagery was provided and revealed the patient annulus with calcification present and the delivery system post procedure with the distal portion of the inflation balloon separated and the spring stretched out.During manufacturing of the commander delivery system, the delivery system and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A device history record review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A review of the lot history revealed no other similar returned complaints for the trend categories.However, no manufacturing non-conformances were identified during the investigations of the similar complaints.The instructions were reviewed instruction for use (ifu) for commander delivery system with s3u, device preparation manual, device training manual and no ifu/training deficiencies were identified.The procedural training manual provides guidance on balloon burst.If the delivery system balloon bursts or leaks during deployment without thv embolization, do not use excessive force, take care when crossing the thv, tracking back over the arch and removing the delivery system (through the tip of the sheath), maintain guidewire position, check for pv leaks under echo and if post-dilation needed, use a new delivery system and sheath.Take care when crossing the deployed valve to prevent potential embolization.Additional guidance for balloon burst.If a balloon burst is suspected, do not attempt to pull back the delivery system into the sheath until you are prepared to conduct the following steps: attempt to visualize location of tear either in tee or via angio through the pigtail or catheter/delivery system, when removing, ensure the catheter/delivery system and wire are coaxial with the sheath tip, watch under fluoro with every movement, be patient and pull gently especially near tear and balloon shoulder transitions and do not force if resistance is met near or at the sheath tip (force could result in additional tearing of the balloon material and the balloon material or tip coming off).If successful in pulling the entire balloon and delivery system tip into the tip of the sheath, withdraw the delivery system and sheath as a single unit completely from the arteriotomy while maintaining guidewire position, do not attempt to pull the delivery system through the remaining length of the sheath.If unable to pull the entire balloon into the sheath, do not attempt to remove the exposed balloon through the entire peripheral vasculature, as there is risk of major complications, conversion to surgery is recommended to remove the system and a surgeon should be in a position to be able to evaluate the situation, based on a medical assessment of the size, tortuosity, and extent of calcification of the peripheral vessels, evaluate the risks and tradeoffs of carefully withdrawing the system into a more peripheral anatomy in order to allow a more localized surgical procedure, consider use of an occlusion balloon to mitigate bleeding risks, especially if there is resistance encountered during withdrawal.If resistance is unacceptably high, convert to surgery rather than using excessive force to pull the sheath/delivery system to a different position, ensure the valve is well opposed.If it is not, you must post dilate immediately with another balloon or delivery system and sheath and take care when crossing the deployed valve to prevent potential embolization.A review of the risk management documentation was performed, and 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 complaint for balloon burst, distal tip and difficulty or inability to withdraw system through sheath were confirmed by visual inspection of the returned device as well as returned imagery.However, no manufacturing non-conformance was identified during the evaluation.Dimensional inspection of the returned balloon revealed that the balloon wall thickness was within specification.No visual abnormalities were observed on the returned sample.An existing technical summary has been documented for root cause analysis on balloon bursts in a calcified landing zone.A detailed root cause analysis for similar returned balloon burst complaints has been summarized in technical summary.The technical summary provides a rationale as to why it is unlikely that a product defect or manufacturing non-conformance contributed to this type of event, including factors on why deployment of balloons on thv delivery systems are subject to increased risk of burst in a calcified landing zone.Severely calcified annulus with severely calcified & narrow stj.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested for rated burst pressures well above their inflation pressure, calcified nodules can compromise the structure of the balloon wall via following mechanisms such as puncture, local overstretching, open cell impingement, or stress concentration.As the balloon was burst, the altered balloon profile can be more susceptible to catch on the distal end of sheath tip which would have then led to the experienced retrieval difficulty.As a result, additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.In addition, the technical summary outlines the extensive manufacturing mitigations in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing that occurs with every manufactured lot).These inspections and testing further support that it is unlikely that a defect present in manufacturing contributed to the complaint.The technical summary also outlines the instructions for valve deployment.It should be noted that these mitigations are still in place.Review of available information suggests that patient factors (calcification) contributed to the balloon burst while procedural factors (withdrawal of burst balloon, excessive manipulation) contributed to the withdrawal difficulty and separation.Technical summary is applicable to this complaint.As such, an engineering evaluation is not required.Control limits are managed and assessed through.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.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action (capa) nor product risk assessment (pra) is required at this time.In this case, an unspecified vascular injury occurred.The operators experienced withdrawal difficulty of the devices through the sheath.This was likely caused by device manipulation during withdrawal and/or patient factors (calcification and possibly challenging anatomy) that may have contributed to the complaint event resulting in an unexpected medical intervention and a vascular stent deployment.

• 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 ; 9492506385
• MDR Report Key: 12447508
• MDR Text Key: 270569622
• Report Number: 2015691-2021-05078
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207835
• UDI-Public: (01)00690103207835(17)230520(10)63789349
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: 9750CM26A
• Device Catalogue Number: 9750CM26A
• Device Lot Number: 63789349
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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): Required Intervention
• Patient Sex: Male