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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 1550250-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/17/2021
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 infection 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 treatments appear 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.
 
Event Description
It was reported that on (b)(6) 2021 the patient presented with a st-elevation myocardial infarction and a 2. 5x12mm xience sierra stent was implanted. On (b)(6) 2021, the patient was re-admitted with unspecified cardiovascular symptoms and acute pericarditis. Unspecified treatment was provided and the final patient outcome is not known. 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 Key12395309
MDR Text Key269767717
Report Number2024168-2021-07725
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,other
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1550250-12
Device Catalogue Number1550250-12
Device Lot Number1030841
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 Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
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