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

Model Number 9600LDS26J

Device Problems Deflation Problem (1149); Inflation Problem (1310); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.Device was discarded.

Event Description

A trans subclavian transcatheter aortic valve replacement procedure with a 26mm sapien 3 valve was performed.The valve was inflated with nominal volume after rapid pacing.More resistance than usual was encountered, however valve expansion was successful.The physician tried to deflate the balloon, but its speed was very slow.After deflation succeeded to some extent, rapid pacing stopped.The procedure was completed with no valve dysfunction.After checking the commander delivery system that was withdrawn, a kink at the triple marker was observed.There was no abnormality during device prep.The patient was stable at the end of the procedure.

Manufacturer Narrative

Update to d9 (device availability), g6, h3 (device evaluated by manufacturer), h6 (component code, device code, type of investigation, investigation findings, and investigation conclusions) and h10 to reflect device evaluation.The 26mm commander delivery system was returned to edwards for evaluation.Visual inspection revealed the following: minor bend on guidewire lumen near triple markers and inflation balloon returned unpleated.Functional testing was performed, and the balloon was inflated and deflated with the returned inflation device and the balloon was fully inflated with no balloon leakage, rotation or abnormalities observed.In addition, the inflation/deflation time met specifications.Dimensional testing was not performed due to the nature of the complaint.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 record review was performed and did not reveal any related complaints.The commander delivery system ifu, device preparation training manual, device procedural training manual and procedural manual supplemental for subclavian and axillary approach have been reviewed for instructions and guidance.The device procedure manual provides guidance on tortuosity of degree and location.Sharp angles are responsible for potential sheath kinking, subclavian/axillary dissection and aortic arch damage and left axillary approach limited to left subclavian takeoff angle approximately <90 degrees from the aortic arch.In addition, the device procedure manual provides guidance on delivery system insertion and tracking and valve alignment when crossing and pulling back the flex catheter.Insert delivery system until delivery system tip crosses annulus in order to have enough length to do valve alignment in ascending aorta.Do not use any flexing during tracking.The sheath can bend and does not necessarily represent an obstacle for valve insertion, and retrieve system (delivery system, valve and sheath) together as one unit if substantial resistance is encountered.For right side approach, insert delivery system upside down to utilize flex during valve positioning, retract the sheath while keeping the delivery system in place until the valve is exposed, and perform valve alignment in straight section of the vasculature (not inside sheath).Tapered tip of the delivery system will come back across the aortic valve into aorta, continue to track and cross without flexing and pull back flex catheter.There were no ifu/training deficiencies 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.The complaint for excessive inflation and deflation duration was unable to be confirmed.However, the complaint for component damaged was confirmed based on evaluation of the returned complaint device.However, a manufacturing non-conformance was unable to be determined.A review of dhr, lot history, and complaint history 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, 'the valve was inflated with nominal volume after rapid pacing.Resistance that the operator had never felt before was encountered.The valve expansion was managed to be succeed.The operator tried to be deflated the balloon, but its speed was very slow.After deflation had succeeded to some extent, rapid pacing stopped.It increased 10 atm during inflation.The procedure was completed as no valve dysfunction' and 'after checking commander delivery system that was withdrew, kink at triple marker was confirmed.There was no abnormality during device prep.No adverse event occurred'.Evaluation of the returned complaint device revealed a minor bend on the guidewire lumen near the triple markers.Additionally, device evaluation revealed the inflation/deflation time met specification.It is possible that during the transaxillary approach, the patient's anatomy presented difficult bend angles or constrained condition resulting in higher resistance for the delivery system to overcome during tracking and subsequently affecting inflation and deflation.It is possible that excessive manipulation was used to overcome this resistance and kinked the distal end of the delivery system potentially constraining the fluid pathway during thv deployment.These factors can potentially lead and contribute to the reported difficulty felt when attempting to deploy the valve in the target location.In this case, available information suggests that patient (tortuosity) and/or procedural factors (excessive manipulation, inflation with kinked delivery system) contributed to the reported event.However, without applicable procedural imagery, a conclusive root cause is unable to be determined.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.No corrective or preventative action nor product risk assessment is required.

• Brand Name: EDWARDS COMMANDER DELIVERY
• 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: 14859129
• MDR Text Key: 302122225
• Report Number: 2015691-2022-06450
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194876
• UDI-Public: (01)00690103194876(17)231104(10)64073093
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2023
• Device Model Number: 9600LDS26J
• Device Lot Number: 64073093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2021
• 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 Age: 86 YR
• Patient Sex: Male