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

Model Number 9610TF26U

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Intraoperative Pain (2662)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing.

Event Description

As reported from our affiliates in france, it was a case of an implant of a 26mm sapien 3 ultra valve, in aortic position by transfemoral approach.The native valve was not pre-dilated.During the procedure, valve alignment was performed in a straight section of the aorta without any difficulty.Nominal volume was used for inflation of the balloon of the commander delivery system, but it burst at the end of valve deployment.The valve was implanted in the correct position without embolization.As the balloon burst circumferentially, it was not possible to reintroduce it in the sheath, leading to withdrawal difficulties.This event was painful for the patient.It was tried to use a snare with cross lateral femoral but without success.It was decided to call a vascular surgeon to remove the yellow nosecone and the balloon of commander delivery system that were separated, by cutdown.The valve was post-dilated to be sure to avoid an incomplete valve expansion.After the procedure, the patient outcome was good, but gradient was high (26mm hg) detected by echography.A new scan was requested.As per medical opinion, the root cause of this event was a material defect.

Manufacturer Narrative

H10: updated sections h6- component code, type of investigation, findings, and conclusions.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The returned device was visually examined, and the following was observed: the flex shaft and balloon shaft were received cut, separated from the remaining part of the delivery system.There was a balloon radial and longitudinal burst.The nose tip and distal part of the balloon were separated.Distal part of the balloon was bunched towards the nose tip.Balloon wings were flared.The spring coil was stretched at the proximal part (square).All measurements taken of the balloon single wall thickness met the specification.Imagery was provided by the site and revealed the following: what appears to be a snared/separated part of balloon material withdrawn from patient.Flex shaft and balloon are cut, separated from the remaining part of the delivery system.The nose tip and distal part of the balloon were separated.The distal part of the balloon was bunched towards the nose tip.Balloon wings were flared.There was a balloon radial and longitudinal burst.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaints for delivery system balloon burst, inability to withdraw system through sheath, and distal tip separation were confirmed based on evaluation of the returned device and provided imagery.Available information suggests that patient factors (calcification) likely contributed to the delivery system balloon burst as provided information indicated presence of calcification in patient's annulus/leaflets.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst 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.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the inability to withdraw system through sheath as the balloon was burst circumferentially, potentially forming an umbrella shape during withdrawal.As the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of sheath tip, which would have then led to the experienced retrieval difficulty.Available information suggests procedural factors (excessive manipulation / pull force) likely contributed to the distal tip separation as stretching was observed on the spring coil of the returned delivery system.Additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

Manufacturer Narrative

Updated section h6- device codes.The event reported is an anticipated in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The returned device was visually examined, and the following was observed: the flex shaft and balloon shaft were received cut, separated from the remaining part of the delivery system.There was a balloon radial and longitudinal burst.The nose tip and distal part of the balloon were separated.Distal part of the balloon was bunched towards the nose tip.Balloon wings were flared.The spring coil was stretched at the proximal part (square).All measurements taken of the balloon single wall thickness met the specification.Imagery was provided by the site and revealed the following: what appears to be a snared/separated part of balloon material withdrawn from patient.Flex shaft and balloon are cut, separated from the remaining part of the delivery system.The nose tip and distal part of the balloon were separated.The distal part of the balloon was bunched towards the nose tip.Balloon wings were flared.There was a balloon radial and longitudinal burst.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.The complaints for delivery system balloon burst, inability to withdraw system through sheath, and distal tip separation were confirmed based on evaluation of the returned device and provided imagery.Available information suggests that patient factors (calcification) likely contributed to the delivery system balloon burst as provided information indicated presence of calcification in patient's annulus/leaflets.The presence of calcification can create a challenging anatomy for balloon inflation.While the balloons are sufficiently designed and tested to ensure the burst pressure is at or above the rated burst 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.Available information suggests procedural factors (withdrawal of burst balloon) likely contributed to the inability to withdraw system through sheath as the balloon was burst circumferentially, potentially forming an umbrella shape during withdrawal.As the balloon was burst, the altered balloon profile could have made it more susceptible to catch on the distal end of sheath tip, which would have then led to the experienced retrieval difficulty.Available information suggests procedural factors (excessive manipulation / pull force) likely contributed to the distal tip separation and balloon separation as stretching was observed on the spring coil of the returned delivery system.Additional pull force/excessive device manipulation could have been applied to overcome the withdrawal difficulty which then led to the reported separation.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• 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
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18842714
• MDR Text Key: 336956865
• Report Number: 2015691-2024-01617
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103208078
• UDI-Public: (01)00690103208078(17)250724(11)230725
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Model Number: 9610TF26U
• Device Catalogue Number: N/A
• Device Lot Number: 65207222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 05/14/2024; 05/14/2024
• Supplement Dates FDA Received: 05/14/2024; 05/15/2024
• Date Device Manufactured: 07/25/2023
• 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 Age: 57 YR