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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 1550300-18
Device Problems Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history did not indicate a lot specific quality issue. The investigation determined the reported difficulties appear to be related to the operational context of the procedure. In this case, it is likely the device interacted with the heavily tortuous lesion during advancement, as resistance was noted, resulting in the reported failure to advance. Further interaction with the challenging anatomy during advancement likely contributed to the reported material separation. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that this was a procedure to treat the radial artery with heavy tortuosity. A 3. 0x18mm xience sierra stent delivery system (sds) was advancing towards the target lesion; however, resistance met during advancement due to the heavy tortuosity. Prior to reaching the target lesion, the mid shaft became separated. Since the sds did not advance far enough (both parts still within reach outside the body), both separated parts were able to be simply removed. The target lesion was successfully treated with a new 3. 0x18mm xience sierra sds. 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 Key12303750
MDR Text Key266002703
Report Number2024168-2021-07045
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
Report Date 08/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/11/2022
Device Model Number1550300-18
Device Catalogue Number1550300-18
Device Lot Number0110641
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 Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No

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