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

Model Number 9610TF29

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 10/28/2021

Event Type  Injury  

Event Description

As reported by our affiliate in (b)(6), during a mitral valve in valve (viv) procedure, a 29mm sapien 3 valve was implanted in a failing mitral surgical valve by the transfemoral-transseptal approach.After a successful transseptal (ts) puncture, the commander delivery system was advanced via a lunderquist guidewire and positioned for implantation.Due to a sudden pressure drop, a pericardial effusion was suspected and determined to be probably caused by the guidewire manipulation.It was determined that the pericardial effusion was caused by a left ventricular (lv) perforation close to the apex.The patient was resuscitated, and the pericardial effusion puncture site was sutured by the full sternotomy approach.The commander system was successfully recovered and removed from patient.Immediately after the patient was stabilized, a 29mm sapien 3 valve was successfully implanted viv in mitral position by the transapical approach while the chest was still open.At the time of the report, the patient was okay and sent to emergency care.

Manufacturer Narrative

Per the instructions for use (ifu), cardiovascular injuries, including perforation or dissection of vessels, ventricle, myocardium or valvular structures, are potential adverse events associated with standard cardiac catheterization, balloon valvuloplasty and the transcatheter aortic valve replacement (tavr) procedure.There are several potential etiologies for ventricular perforation during a tavr procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest in addition to procedural factors (manipulation of the guidewire, devices), patient factors (advanced age - 84 years) may have contributed to the lv perforation during the mitral viv procedure.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.

• 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
• 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: 12828180
• MDR Text Key: 282904585
• Report Number: 2015691-2021-06335
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2022
• Device Model Number: 9610TF29
• Device Catalogue Number: N/A
• Device Lot Number: 63435183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• 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 Age: 84 YR
• Patient Sex: Male