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

Model Number 9750CM23A

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Separation (1562)

Patient Problems Unspecified Vascular Problem (4441); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported by a field clinical specialist (fcs), during valve deployment of a 23 mm sapien 3 ultra valve in the aortic valve via transfemoral approach, the balloon dislodged from nosecone as soon as the operator began inflating.The balloon stayed in normal position.The valve did not expand.There was no tortuosity and no tension in the system.The devices were surgically removed from body at the access site.A second valve was successfully implanted.The patient is alive and was discharged the next day.

Manufacturer Narrative

Corrections to sections b1 and b2.Investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 clinical code, device code, investigation conclusions and investigation findings.Added new information to h.6 component codes and type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Inflation balloon observed separated from the distal nose tip, no abnormalities observed on the crimp balloon to balloon shaft bond and no other abnormalities observed on the balloons or i/c bond.Imagery was provided from the site and revealed the following: inflation balloon observed separated from the distal nose tip.3mensio revealed calcification observed within the patient's aortic arch and calcification observed within the patient's arterial anatomy.During manufacturing, the device undergoes multiple inspections.In addition, the work order underwent functional product verification testing as a requirement for lot release.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint for balloon leak was confirmed based on evaluation of the returned complaint device and provided imagery.However, the complaint for difficulty or inability to withdraw system with valve through vasculature was unable to be confirmed as no applicable imagery was provided for evaluation.A review of the dhr and lot history revealed a potential manufacturing non-conformance issue that could have contributed to the complaint event.Additionally, a review of the ifu and training manuals revealed no deficiencies.Balloon leak: as reported, ''during valve deployment of a 23 mm sapien 3 ultra valve in the aortic valve via transfemoral approach, the balloon dislodged from nosecone as soon as the operator began inflating.The balloon stayed in normal position.The valve did not expand''.Evaluation of the returned complaint device revealed a separation between the inflation balloon and the distal nose tip.During manufacturing process, balloon catheters are visually inspected and 100% leak tested.Although this device passed inspection and was prepped with no abnormalities, this bond separation seen on the complaint unit indicates that the manufacturing process was potentially done incorrectly.Difficulty or inability to withdraw system with valve through vasculature.As reported, ''there was withdrawal difficulties and the devices were surgically removed from body at the access site''.Per 3mensio review, calcification was present in the vasculature.The presence of calcification can create suboptimal angles for delivery system withdrawal.Suboptimal anatomy can cause the crimped thv to get caught on patient vasculature or sheath tip and contribute to withdrawal difficulties.However, without applicable procedural imagery, a definitive root cause is unable to be determined.Available information suggests that patient factors (calcification) and/or procedural factors (withdrawal of crimped valve) may have contributed to the complaint 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.No ifu/labeling/training manual inadequacies were identified.A product risk assessment (pra) and a corrective action preventative action (capa) were previously initiated to capture the investigation of these type of events and drive any potential corrective/preventative actions.

• 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: 16011746
• MDR Text Key: 305786723
• Report Number: 2015691-2022-10158
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9750CM23A
• Device Catalogue Number: 9750CM23A
• Device Lot Number: 64367924
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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): Required Intervention
• Patient Sex: Male