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

Model Number 9600LDS29A

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Material Separation (1562); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)4).Per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.The device was unavailable to be returned for evaluation.Transcatheter delivery balloon burst complaints have been previously investigated by edwards and documented in a technical summary written by edwards lifesciences.  a detailed root cause analysis revealed that it is very unlikely that a product defect contributes to this type of event.There are extensive manufacturing inspections in place to prevent this type of malfunction (visual and dimensional inspections, leak testing, and functional balloon burst testing performed to every manufactured lot).The thv delivery system balloons are subject to increased risk of burst due to contact with a highly calcified annulus.Analysis revealed that these types of ruptures are typically caused by puncture from calcium on the native aortic valve when the inflated delivery system balloon comes in contact with the native annular calcification at full inflation/deployment.In addition, the balloon burst increases the possibility of an obstacle (i.E.Patient's anatomy or sheath tip) interfering with retraction of the balloon/balloon material.The physician training manual provides the following instruction: if the inflation balloon leaks or bursts, do not use excessive force when removing the balloon.In this case, the exact cause of the balloon burst cannot be confirmed; however, it was likely due to patient factors (severely calcified annulus).  although the exact cause cannot be determined, it is possible that the retrieval of the ruptured balloon through the esheath may have resulted in the balloon material separation.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required at this time.

Event Description

As reported by a field clinical specialist, upon deploying a 29 mm sapien 3 valve in the aortic position via transfemoral approach in a heavily calcified native annulus, the balloon burst.The valve was already fully deployed when the balloon burst, and post dilatation was not required.The delivery system had been prepped with nominal volume.No difficulty was encountered when withdrawing the delivery system from the esheath (the esheath was left in place).Upon removal, it was observed that a piece of balloon material (approximately 2 inches long and 1 inch wide) was missing.It was unclear if it happened at the time of the burst or upon removal of system through the sheath.Interventional radiology was consulted and ¿shot angios of head vessels, abdominal aorta and femoral arteries¿ were taken to locate the piece, but it remained missing.The esheath was also inspected by being flushed and cut open, but the balloon piece remained missing.The patient was doing well post procedure and discharged in stable condition.

Manufacturer Narrative

Additional information g3 updated and stated this report is related to medwatch number: (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• 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
• MDR Report Key: 10038784
• MDR Text Key: 194931353
• Report Number: 2015691-2020-11812
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 9600LDS29A
• Device Lot Number: 62743591
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/08/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 07/23/2020
• Supplement Dates FDA Received: 06/24/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR