• 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 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

  • 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 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070400-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Hypersensitivity/Allergic reaction (1907)
Event Date 10/15/2021
Event Type  Injury  
Event Description
It was reported that the patient had a xience xpedition stent implanted in the left anterior descending (lad) coronary artery on (b)(6) 2021. The patient returned the week of (b)(6) 2021 to further assess the downstream bifurcation lesion but now has aneurysmal vessel around the stent. On intravascular ultrasound (ivus), there is a black echo-lucent space between the stent struts and the adventitia. This extends throughout the length of the stent, not just the aneurysmal section. There is potential the patient has an allergy to polymer. No treatment has been performed but the aneurysm will be monitored. No additional information was provided.
 
Manufacturer Narrative
Estimated date. The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12759437
MDR Text Key282772952
Report Number2024168-2021-10019
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeNZ
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/06/2022
Device Catalogue Number1070400-15
Device Lot Number9053041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
-
-