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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
Model Number 1550250-12
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
Event Type  malfunction  
Manufacturer Narrative
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 this was a percutaneous coronary intervention in the heavily calcified mid left circumflex coronary artery. The 2. 5x12 mm xience sierra stent delivery system (sds) was advanced without resistance when the proximal shaft separated in two pieces outside the body. The separated segment was removed from the sheath using a hemostat. The entire sds was removed without incident. Another xience sierra was inserted and used without further incident. There were no adverse patient effects and no clinically significant delay in the procedure. There was no additional information provided.
 
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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 Key12288461
MDR Text Key265407556
Report Number2024168-2021-06903
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
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 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1550250-12
Device Catalogue Number1550250-12
Device Lot Number1020241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
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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