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

Model Number 9750CM20A

Device Problem Inflation Problem (1310)

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

Event Date 03/07/2024

Event Type  malfunction  

Event Description

As reported by an edwards lifesciences affiliate, regarding a 20mm sapien 3 ultra resilia valve in the aortic position, while deploying the valve, the 20mm commander delivery system balloon filled at the outflow first and then the inflow.The inflow of the valve appeared to pop open at the end of deployment when it usually smooth and fluid.No harm to patient.No pvl, minimal gradient by echo.

Manufacturer Narrative

Investigation is underway.

Manufacturer Narrative

Additional information: h6 the device was not returned for evaluation.Imagery was provided for review.The 3mensio report was evaluated and the following was observed: calcification present in the landing zone and access vessels.Video of procedure under fluoro was evaluated and the following was observed: prior to deployment, the crimped valve appears to be located between the alignment markers.During initial deployment, the proximal side of the balloon is observed to inflate first.Once near full inflation, the balloon is observed to inflate evenly across the balloon including on the distal side.Post deployment, the valve appears to be fully expanded and deployed successfully.The reported event was confirmed based on evaluation of the provided imagery.A review of the dhr, lot history, and manufacturing mitigations did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manuals revealed no deficiencies.The provided video revealed the valve initially deployed asymmetrically but was eventually able to fully deploy.While a review of the dhr, lot history, manufacturing mitigations, ifu and training manuals did not provide any indication that a manufacturing and/or labeling non-conformance would have contributed to the complaint, investigation showed the definitive cause of the event could not be determined.Although the sheath was not returned for evaluation and imagery of the sheath was not provided for review, based on previous investigations of similar events, the reported event may be related to device interactions resulting from a potential sheath distal tip torn.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 (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: 18989168
• MDR Text Key: 338737739
• Report Number: 2015691-2024-02361
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103207811
• UDI-Public: (01)00690103207811(17)250924(10)65344991
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM20A
• Device Lot Number: 65344991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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 Sex: Female