Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS ENDURANT DEVICE; SYSTEM, ENDOVASCULAR GRAFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PERFUSION SYSTEMS ENDURANT DEVICE; SYSTEM, ENDOVASCULAR GRAFT Back to Search Results
Model Number ETBF2816C145E
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Aneurysm (1708); Vascular System (Circulation), Impaired (2572)
Event Date 02/26/2018
Event Type  Injury  
Event Description
The patient has a type 3 endoleak at the flow divider of the medtronic endurant graft and it was definitively defined at the date above.The patient will now likely need to have the graft removed or converted to an aorto-uni endograft with a femoral to femoral graft.This is not the first patient i have seen with this problem and as the endovascular graft as placed in (b)(6) 2017, less than 1 year ago, this has to be considered a significant manufacturing problem.I have heard that this has been a problem and 2 of my colleagues have had patients have the same problem and this is something rather concerning for patient safety.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENDURANT DEVICE
Type of Device
SYSTEM, ENDOVASCULAR GRAFT
Manufacturer (Section D)
MEDTRONIC PERFUSION SYSTEMS
MN
MDR Report Key7391671
MDR Text Key104402229
Report NumberMW5076264
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Device Operator Health Professional
Device Expiration Date03/29/2019
Device Model NumberETBF2816C145E
Device Catalogue NumberSV07365490
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/02/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient Weight141
-
-