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

Model Number 9600LDS29A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Udi: unknown.The investigation of this event is ongoing.

Event Description

Per medical records review, the patient underwent a right side transeptal tmvr procedure for a 29mm sapien 3 valve in a mitral surgical valve.The implant was a success with no lvot obstruction, no paravalvular leak and mean gradient of 3 mmhg.Post deployment, during removal of the delivery system, the atrial lead of a pre-existing permanent pacemaker was dislodged.However, the patient was in controlled atrial-fibrillation post procedure with plan to consult ep.The patient tolerated the procedure very well overall.The patient was discharged home in stable condition on post-operative day 3.

Manufacturer Narrative

At the time of this report, the information available does not reasonably suggest there was a malfunction of the edwards delivery system or that the use or miss-use of the device caused or contributed to the event.In this case, the exact cause for the pacer lead dislodgement cannot be determined.However, there is no indication or allegation that a product deficiency or device malfunction contributed to the event.Per the information provided, the atrial permanent pacemaker lead was noticed upon removal of the delivery system balloon from the septum; however, it was not seen exactly when or how the lead became dislodged because there was a lot of manipulation of devices.Additionally, the medical records did not mention a delivery system or thv device malfunction or interaction.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.

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; 1 edwards way; irvine CA 92614
• MDR Report Key: 9447310
• MDR Text Key: 170662951
• Report Number: 2015691-2019-04580
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600LDS29A
• 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 Outcome(s): Other
• Patient Age: 90 YR