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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 1550300-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Prolapse (2475)
Event Date 09/14/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. It should be noted that the reported patient effect of prolapse is listed in the xience sierra, everolimus eluting coronary stent system, instructions for use, as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, a percutaneous intervention was performed on the distal right coronary artery (rca), 95% stenosed lesion. Pre-dilatation was performed and a 3. 0x28mm xience sierra stent was implanted in the distal rca, without a device issue reported. Following, intra-stent plaque protrusion in the distal stent segment was observed, treated with additional dilatation. Timi flow iii and 0% residual stenosis was observed. Elevated cardiac enzymes were observed post-procedure. There was no myocardial infarction, no treatment, and no serious association with the elevated enzymes. The patient was discharged home the same day the elevation was observed. No additional information was provided regarding this issue.
 
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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 Key11679143
MDR Text Key245809456
Report Number2024168-2021-03208
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/02/2021
Device Model Number1550300-28
Device Catalogue Number1550300-28
Device Lot Number0052741
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 Received03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/16/2021 Patient Sequence Number: 1
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