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

Model Number 9880CM29CL

Device Problem Inflation Problem (1310)

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

Event Date 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The device is not returning.

Event Description

From encircle study, during the procedure of a 29 mm sapien m3 valve in the mitral position via transfemoral approach, the valve was not inflated all the way due to use error.The operator unintentionally did not bottom out the atrion.No change on patient outcome.The valve was deployed and a post-dilation inflation adding 4 cc to atrion 4cc.The valve was implanted with great results.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.Imagery was provided from the site and revealed the following: after balloon expansion, there appears to be a waist on valve.Valve appears to be fully expanded after post-dilation.A review of the risk management documentation was performed, and the reported event is an anticipated risk of the transcatheter heart valve procedure.No evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was confirmed from imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals revealed no deficiencies.As reported, ''the valve was not inflated all the way due to use error.The operator unintentionally did not bottom out the atrion.No change on patient outcome.The valve was deployed and a post-dilation inflation adding 4 cc to atrion 4cc.The valve was implanted with great results.'' per ifu, ''deploy the valve by inflating the balloon with the entire volume in the inflation device, hold for 3 seconds, and confirm that the barrel of the inflation device is empty to ensure complete inflation of the balloon''.In this case, the valve or balloon was not fully inflated due to the operator not emptying the inflation device.As such, available information suggests procedural factors (operator did not use entire volume on inflation device) may have contributed to the reported 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.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: COMMANDER M DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 14519600
• MDR Text Key: 300354592
• Report Number: 2015691-2022-05932
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103214321
• UDI-Public: (01)00690103214321(17)220901(10)63962481
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 9880CM29CL
• Device Lot Number: 63962481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• 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