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

Model Number 9600LDS26A

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported, during a mitral valve in valve procedure (26mm s3 in 25mm surgical valve) via transseptal approach, the commander delivery system balloon burst once it reached full inflation.The valve was deployed as intended with mild to moderate pvl noted post deployment.Upon removal of the delivery system, the balloon was unable to inserted back into the esheath.The delivery system and esheath were then removed as a unit and a second esheath was inserted into the patient.A non ew balloon was used to dilate the valve, which reduced the pvl grade to none-trace.The patient left the room in stable condition.

Manufacturer Narrative

Despite multiple attempts, additional information regarding the case and device status was not provided.  the delivery system was not returned to edwards for evaluation.  information regarding the disposition of the device was not provided.  no relevant imagery of the event was provided per the instructions for use (ifu), balloon rupture is a potential risk of the tavr procedure.  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 this case, per report, patient factors (moderate-severe mac) contributed the balloon burst.The cause of the withdrawal difficulties is attributed to the difficulties experienced while retrieving the delivery system with a balloon burst through the sheath.  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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS COMMANDER DELIVERY SYSTEM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8522749
• MDR Text Key: 142665886
• Report Number: 2015691-2019-01343
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 9600LDS26A
• Device Lot Number: 61757101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR