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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 1550300-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 07/13/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as the stent remains implanted. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of hypersensitivity/allergic reaction is listed in the xience sierra, everolimus eluting coronary stent systems, as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the patient has a history of shortness of breath with exertion. A cta (computed tomography angiography) was performed which found some occlusion with hemodynamic significance. On (b)(6) 2021 the patient underwent a percutaneous coronary intervention in the mid (lad) left anterior descending coronary artery. The 3. 0x23 mm xience sierra stent was implanted in the mid lad. She has a nickel allergy but did not disclose this allergy to the hospital and physician until after the stent was implanted. She was given prednisone medication prior to the procedure as she is allergic to many things such as iodine, lidocaine, contrast, latex, pollen, and animals. When she took the prednisone on (b)(6) 2021, her blood sugar went to the 340s, so she reduced the prednisone dose. The next day, on (b)(6) 2021, she started feeling flushed and itchy on her face and trunk. This is a common reaction for her when she is allergic to something. On 07/15/2021 the itching on her trunk had resolved, but her face was still flushed. The flushed face is not as intense though. 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 Key12228788
MDR Text Key263559162
Report Number2024168-2021-06492
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227271
UDI-Public08717648227271
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1550300-23
Device Catalogue Number1550300-23
Device Lot Number0091741
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 Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/27/2021 Patient Sequence Number: 1
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