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

Model Number 9600LDS26A

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

Patient Problem Perforation (2001)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Exemption number e2016006, this report summarizes 1 event of perforation with or w/o tamponade serious injury event for the sapien 3 in the mitral position.The ¿time to event¿ (tte, in days) for this event was 0.Per the instructions for use, 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 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, specific procedural details are not available to determine potential contributing factors to the event.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.The device identification (di) numbers for edwards commander delivery system are: (b)(4).

Event Description

(b)(6) registry alternative summary reporting (asr) adverse event submission for february 2020 data extract for mitral serious injuries for the sapien 3.February 2020 data extract includes data provided by acc for q3 2019 (july 1 - september 30).  this report summarizes 1 event of perforation with or w/o tamponade serious injury event for the sapien 3 for february 2020.The age for this event was 81.The breakdown for gender is as follows: 1 female.

Manufacturer Narrative

Supplemental report to add noe statement.

Event Description

This report summarizes 1 event of perforation with or w/o tamponade serious injury event for the sapien 3 for february 2020.

Manufacturer Narrative

Supplemental report to resubmit codes.

Manufacturer Narrative

Additionally, at the time the initial report for this mitral event was submitted, the event did not meet the tvtr criteria for summary reporting under exemption e2016006.

Event Description

Per the information received from the thv/tvt registry for february 2020 data extract for mitral serious injuries for the sapien 3 transcatheter heart valve, a perforation with or w/o tamponade occurred.No additional information is available for this event.

• 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 LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: rene dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 9988947
• MDR Text Key: 194115435
• Report Number: 2015691-2020-11569
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600LDS26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR