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U.S. Department of Health and Human Services

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

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EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number COMMANDER DELIVERY SYSTEM UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation (2001); Cardiac Tamponade (2226)
Event Date 03/25/2020
Event Type  Death  
Manufacturer Narrative
Exemption number e2016006, this report summarizes 2 death events of perforation with or w/o tamponade 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 deaths for the sapien 3.February 2020 data extract includes data provided by acc for q3 2019 (july 1 - september 30).  this report summarizes 2 death events of perforation with or w/o tamponade for the sapien 3 for (b)(6) february 2020.The age range for these events are from 78 to 89.The breakdown for gender is as follows: 1 male and 1 female.
 
Event Description
This report summarizes 2 death events of perforation with or w/o tamponade for the sapien 3 for (b)(6) 2020.
 
Manufacturer Narrative
Supplemental report to add noe statement in b5 section.
 
Manufacturer Narrative
Supplemental report to resubmit h6 codes.
 
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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 Key9988980
MDR Text Key188645160
Report Number2015691-2020-11577
Device Sequence Number1
Product Code NPU
Combination Product (y/n)N
PMA/PMN Number
P140031
Number of Events Reported2
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 03/25/2020
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 Model NumberCOMMANDER DELIVERY SYSTEM UNKNOWN
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/25/2020
Initial Date FDA Received04/22/2020
Supplement Dates Manufacturer Received03/25/2020
07/16/2020
Supplement Dates FDA Received04/24/2020
07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age84 YR
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