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: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
  • 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
 

BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/09/2020
Event Type  Injury  
Event Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment but could not cross the lesion.The physician decided to withdraw the stent to pre-dilate the lesion.However, after removing the device out of the sheath, it was noted that the stent was no longer attached to the stent delivery system balloon.Upon imaging, the stent was found lodged at the end of the sheath.The physician was not able to remove the stent from the artery.The physician advanced the stent near the lesion to fully deploy it.The stent was then fully deployed but not in the optimal location.Subsequently, a second stent was placed to fully cover the lesion.The procedure was completed successfully and there were no patient complications nor injuries reported.
 
Event Description
It was reported that stent dislodgement occurred.The stenosed target lesion was located in the iliac artery.A 7.0x30x75cm express ld iliac / biliary stent was advanced for treatment but could not cross the lesion.The physician decided to withdraw the stent to pre-dilate the lesion.However, after removing the device out of the sheath, it was noted that the stent was no longer attached to the stent delivery system balloon.Upon imaging, the stent was found lodged at the end of the sheath.The physician was not able to remove the stent from the artery.The physician advanced the stent near the lesion to fully deploy it.The stent was then fully deployed but not in the optimal location.Subsequently, a second stent was placed to fully cover the lesion.The procedure was completed successfully and there were no patient complications nor injuries reported.It was further reported that the target lesion was 90% stenosed, non-tortuous and mildly calcified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10547119
MDR Text Key207338243
Report Number2134265-2020-12875
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729579663
UDI-Public08714729579663
Combination Product (y/n)N
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/11/2022
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0023939666
Was Device Available for Evaluation? No
Date Manufacturer Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
-
-