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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

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ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070250-18
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that the procedure was to treat a lesion in the heavily calcified, moderately tortuous, 95% stenosed de novo, left anterior descending artery (lad). A 2. 5x18mm xience xpedition drug eluting stent (des) was advanced but was unable to cross the lesion. Upon removal of the stent system, the stent dislodged in the left main artery (lm). A wire was advanced and pushed the dislodged stent into the left circumflex (lcx) artery where a xience stent was implanted to embed the dislodged stent. There was no adverse patient sequela and no reported clinically significant delay in the procedure. No additional information was provided.
 
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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 Key11007647
MDR Text Key221487889
Report Number2024168-2020-10462
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeRP
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/11/2022
Device Catalogue Number1070250-18
Device Lot Number9020441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2019
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: 12/15/2020 Patient Sequence Number: 1
Treatment
HT BMW USL II 0.014" 190CM, 1009664 LOT 9071671.; MINI TREK 1.2 X 12, 1012268-12 LOT 90913G1.; MINI TREK 2.0 X 25, 1012270-25 LOT 90722G1.; TREK 2.25 X 15, 1012271-15 LOT 90724G1.; TREK 2.5 X 12, 1012272-12 LOT 90909G1.; XIENCE XPEDITION 3.5 X 28, 1070350-28 LOT 9042641.
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