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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 1500350-33
Device Problem Unintended System Motion (1430)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
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 the procedure was to treat a heavily calcified, de novo lesion in the left anterior descending (lad) artery. A 3. 5x33mm xience sierra drug eluting stent (des) was advanced to the target lesion, and upon inflation to 2 atmospheres (atm) the delivery system slipped back into the guiding catheter (gc) and the guiding catheter slightly disengaged from the target lesion. The balloon was slightly opened (inflated) and the physician was concerned of the possibility of the stent dislodging from the delivery system into the aorta. The delivery system and the stent were removed without issue and another same size xience sierra des 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 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 Key12708199
MDR Text Key280084667
Report Number2024168-2021-09680
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSN
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 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500350-33
Device Lot Number1060341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2021
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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