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: ABBOTT VASCULAR, INC. XIENCE SIERRA; CORONARY DRUG-ELUTING STENT
  • 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
 

ABBOTT VASCULAR, INC. XIENCE SIERRA; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 1550275-15
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/12/2019
Event Type  malfunction  
Event Description
Wire and stent were snared and pulled back into patient right radial artery.Stent became lodged in right radial artery (located in forearm) unable to pull stent and distal end of wire through sheath.The stent had been deformed and could not enter the guide.The entire system was withdrawn, but the stent could not enter the sheath (still over the wire).The sheath was removed, but the wire and stent were stuck in the radial artery at the insertion site.Rather than risk serious damage to the radial artery, the wire was cut, and the last inch or two of wire plus the deformed stent were left in the distal right radial artery.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XIENCE SIERRA
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR, INC.
3200 lakeside dr
santa clara CA 95054
MDR Report Key8342993
MDR Text Key136273209
Report Number8342993
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1550275-15
Device Catalogue Number1550275-15
Device Lot Number8071141
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/09/2019
Event Location Hospital
Date Report to Manufacturer02/15/2019
Type of Device Usage N
Patient Sequence Number1
-
-