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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 1550300-33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dizziness (2194)
Event Date 10/27/2020
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. The reported patient effect of dizziness is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures. Based on the information reviewed, there is no indication of a product quality issue. A conclusive cause for the reported patient effects, 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 of the device. Na.
 
Event Description
It was reported that a 3. 0x33mm xience sierra stent was implanted on (b)(6) 2020. The patient had previously presented with atherosclerotic heart disease. On (b)(6) 2020, the patient was readmitted with other cardiovascular symptoms including dizziness. Treatment performed was unspecified and the final patient outcome is unknown. 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 Key11445599
MDR Text Key238642121
Report Number2024168-2021-01849
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 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/29/2021
Device Model Number1550300-33
Device Catalogue Number1550300-33
Device Lot Number0032341
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 Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/09/2021 Patient Sequence Number: 1
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