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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070350-33
Device Problems Difficult to Remove ; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress
Event Date 12/13/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Exemption number e2019001. The device is not returning 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 performed to treat a de novo lesion in the heavily tortuous, mildly calcified, 90% stenosed distal left anterior descending coronary artery. A bmw universal guide wire crossed the lesion and a non-abbott balloon was used for pre-dilatation. A 3. 5x33mm xience xpedition stent delivery system (sds) failed to cross due to the anatomy and faced resistance with the anatomy during removal. Force was applied to removed the sds, and the shaft was noted to be kinked. A same size xience xpedition stent was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

 
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Brand NameXIENCE XPEDITION
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 Key9547875
Report Number2024168-2020-00227
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1070350-33
Device LOT Number7080141
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 Received01/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/14/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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