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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 1550400-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Hypersensitivity/Allergic reaction (1907)
Event Date 03/24/2019
Event Type  Injury  
Event Description
It was reported the 4. 0x28mm xience sierra stent was implanted in the left anterior descending on (b)(6) 2019, to treat a st-elevation myocardial infarction stemi. Soon after the procedure, sometime in (b)(6) 2019, (date not provided), the patient was re-hospitalized with strong heart palpitations, no treatment was performed. The patient continued with palpitations and continued to return to the hospital 7-8 times. No treatment was performed. Berlinta was continued to be taken for more than two years after the procedure. A cardiac catheterization was performed about a year ago; the stent appeared clear, with no obstruction. The patient obtained a second opinion with a new cardiologist. The cardiologist instructed the patient to stop taking berlinta and to take aspirin. Recently the patient had a right foot wound in which surgical tape was used. The tape caused a second-degree burn to the foot. An allergy test was performed. The results came back the patient is allergic to nickel sulfate hexahydrate, potassium dichromate, and chrome/chromium metal. The patient is concerned that the palpitations he has been experiencing have been due to the sierra stent, because he is allergic to chromium metal. No additional information was provided.
 
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. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent 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; therefore, no product-related corrective action will be implemented in this case. Estimated date of event: (b)(6) 2019.
 
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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 Key13930326
MDR Text Key288044244
Report Number2024168-2022-03236
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227523
UDI-Public08717648227523
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/11/2019
Device Model Number1550400-28
Device Catalogue Number1550400-28
Device Lot Number8062641
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/28/2022 Patient Sequence Number: 1
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