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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1500350-18
Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a heavily tortuous, moderately calcified left anterior descending artery (lad) with a previous coronary artery bypass graft using the mammary artery. The 3. 5x18mm xience sierra stent delivery system (sds) was advanced and met resistance with anatomy; however, the sds was re-inserted and resistance was noted with the use of an unspecified microcatheter and anatomy during advancement and withdrawal. The sds shaft separated in the microcatheter. All the separated portions were removed with the removal of the microcatheter. Another non-abbott stent and new microcatheter were used to successfully complete the procedure. There was no adverse patient effect reported and no clinically significant delay reported. No additional information was reported.
 
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Brand NameXIENCE SIERRA 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 Key13011155
MDR Text Key285741905
Report Number2024168-2021-11622
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeBE
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 02/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500350-18
Device Lot Number1022341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2021
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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