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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 1550300-38
Device Problems Leak/Splash (1354); Insufficient Information (3190)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
Event Type  malfunction  
Manufacturer Narrative
A visual, dimensional and functional inspection was performed on the returned device. The reported insufficient information (faulty hub/balloon) was confirmed as a side arm/hub leak. 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 identified no similar incidents from this lot. The investigation determined the reported and noted difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
It was reported that the box of the 3. 0x38 mm xience sierra stent delivery system had written "faulty hub, balloon" on the outside. Reportedly, the device had been used in the mid left anterior descending (lad) coronary artery. No adverse patient effects were reported and there was no reported clinically significant delay in the procedure. No additional information was provided. Returned device analysis identified a leak in the hub.
 
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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 Key10440279
MDR Text Key204000739
Report Number2024168-2020-07025
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 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2021
Device Model Number1550300-38
Device Catalogue Number1550300-38
Device Lot Number0031341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Is This a Reprocessed and Reused Single-Use Device? No

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