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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK XIENCE V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Myocardial Infarction (1969); Thrombosis (2100); Sudden Cardiac Death (2510)
Event Date 06/18/2013
Event Type  Death  
Manufacturer Narrative
Date of death estimated. Date of event estimated. Implant date estimated. The device was not returned for evaluation. A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided. The reported patient effect of death is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures. A conclusive cause for the reported death 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. Literature title : five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients.
 
Event Description
It was reported through a research article identifying xience v stents that may be related to the following: thrombosis, myocardial infarction (mi), target lesion failure (tlf), target lesion revascularization (tlr), target vessel revascularization (tvr), and cardiac death. The article summarizes outcomes of 694 patients treated with a xience v stents. Specific patient information is documented as unknown. Details are listed in the article, titled "five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients".
 
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Brand NameXIENCE 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 Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11368652
MDR Text Key233240554
Report Number2024168-2021-01392
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeNL
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK XIENCE V
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 Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
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