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

Model Number 9600LDS29A

Device Problem Difficult to Remove (1528)

Patient Problem Perforation of Vessels (2135)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Edwards received notification from a field clinical specialist that a patient underwent a right sided transfemoral viv tmvr in a surgical valve.As reported, post deployment of a 29mm s3 valve, the 16 fr esheath plus seam split (liner torn) as the commander delivery system was withdrawn through it.The right common iliac vein was perforated and ballooned.Ultimately a stent was implanted to repair the vessel perforation.A new esheath was used to fracture the previous non-edwards surgical valve.

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be completed upon completion.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted/discarded.Therefore, a no product return engineering evaluation was performed.Imagery was provided and the following was observed: 3mensio report; calcification was present in the patient's annulus.However, there was no relevant imagery of access vessel provided.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 of difficulty to withdraw delivery system through sheath was unable to be confirmed as neither the complaint device nor applicable imagery was provided for evaluation.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined.A review of the dhr and lot history did not provide any indications that a manufacturing non-conformance would have contributed to the complaint.Additionally, a review of the ifu and training manuals revealed no deficiencies.Per the complaint description, ''it was learned that there was coaxial alignment of the delivery system upon re-entry into the distal end of the sheath''.Difficulty removing the delivery system through the esheath was encountered.The 3mensio provided did not have any imagery related to the access vessel; therefore, no patient factors could be identified as contributing to the event.The delivery system was said to be withdrawn coaxially through the sheath tip.It's possible the balloon profile of the delivery system was altered due to residual fluid, or the system still retained some flex prior to its retrieval.If so, these factors could have contributed to the reported withdrawal difficulty, ''there was difficulty on withdrawal of delivery system''.It is possible excessive manipulation was used when pulling the delivery system through the sheath tip resulting in the alleged torn liner.However, due to the lack of relevant patient/procedural imagery, a definitive root cause is unable to be determined.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment (pra) is required at this time.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.

• 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: 15396807
• MDR Text Key: 299662961
• Report Number: 2015691-2022-07820
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103193961
• UDI-Public: (01)00690103193961(17)240615(10)64395604
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

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 Expiration Date: 06/15/2024
• Device Model Number: 9600LDS29A
• Device Catalogue Number: N/A
• Device Lot Number: 64395604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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: Female