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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number TA DELIVERY SYSTEM UNKNOWN
Device Problems Difficult to Remove (1528); Failure to Advance (2524)
Patient Problem Perforation of Vessels (2135)
Event Date 02/08/2022
Event Type  Death  
Manufacturer Narrative
The investigation is ongoing.The device is not returning.
 
Event Description
As reported, during a subclavian/axillary tavr procedure of a 23 mm sapien 3 ultra valve in the native aortic valve, the valve got stuck at the ostium of the left subclavian and the aortic arch outside of the sheath.The subclavian artery was avulsed from the arch.Some resistance was felt when the sheath was inserted.The patient expired during procedure.
 
Manufacturer Narrative
A supplemental mdr is being submitted for correction and additional information base on the field clinical specialist's (fcs) response.The following sections of this report have been updated: corrected h.6 device code and h10.Additional information, per the fcs, the anatomy was tortuous.Unappreciated calcification at ostium of subclavian.There was difficulty noted and the injury occurred during withdrawal.
 
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 component codes and investigation conclusions.Added new information to h.6 type of investigation and investigation findings.The commander delivery system 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.The imagery provided by the site includes the patient's 3mensio imagery which shows the following: calcification and tortuosity are present in the patient's access vessel and both the right and left subclavian arteries are undersized.Additionally, images of the devices after the procedure were provided, the following was observed: a piece of tissue can be noted on inflation balloon, with the delivery system fully inserted through the sheath.During manufacturing, the device undergoes multiple 100% inspections.In addition, the work order underwent functional product verification testing on a sampling basis 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.The instructions for use/training manuals were reviewed for guidance/instruction involving the delivery system usage.Based on the review of the ifu/training manuals, no deficiencies were identified.A review of the risk management documentation was performed, and 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 complaints were confirmed through the provided imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Without the work order information, a review of the device history record and lot history was unable to be performed and is unable to confirm that a manufacturing non-conformance contributed to the complaint.A review of the 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.In this case, ''the valve got stuck at the ostium of the left subclavian and the aortic arch outside of the sheath.The subclavian artery was avulsed from the arch.'' the provided imagery revealed the patient's subclavian arteries were calcified, tortuosity, and undersized.As such, it is possible that the patient factors contributed to the tracking and withdrawal difficulties noted.Obstructive calcification, in addition to an undersized vessel, may have prevented the advancement of delivery system and contributed to withdrawal difficulties by reducing the vessel lumen diameter and may increase restriction and friction.Additionally, tortuosity may result in a non-coaxial insertion, further contributing to withdrawal difficulties.While a definitive root cause is unable to be determined due to lack of returned device and procedural imagery, available information suggests that patient factors (calcification, tortuosity, vessel size) may have contributed to the complaint events.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 (capa) nor product risk assessment (pra) is required at this time.
 
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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 Key13698015
MDR Text Key286834021
Report Number2015691-2022-04321
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140031
Number of Events Reported1
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 05/04/2022
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 Model NumberTA DELIVERY SYSTEM UNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/08/2022
Initial Date FDA Received03/08/2022
Supplement Dates Manufacturer Received03/15/2022
05/03/2022
Supplement Dates FDA Received03/30/2022
05/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient SexFemale
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