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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 1070250-15
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The additional device referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat the moderately calcified, heavily tortuous left circumflex coronary artery. Pre-dilatation was performed with a non-abbott 2. 00x15 mm balloon and the 2. 5x15 mm xience xpedition stent delivery system (sds) was attempted but could not cross the lesion after a few attempts due to the anatomy. When the sds was removed from the anatomy, the proximal shaft was separated outside the anatomy. A 2. 5x18 mm xience xpedition sds was then attempted but again could not cross the lesion due to resistance during advancement due to the anatomy. The sds was removed and a non-abbott sds was used to complete the procedure. There were no other device issues noted. There were no adverse patient effects and there was 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 Key12689264
MDR Text Key278139078
Report Number2024168-2021-09561
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMY
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 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070250-15
Device Lot Number1020141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
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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