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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)
Event Date 07/18/2017
Event Type  Injury  
Manufacturer Narrative
The majority of patients were over or equal to 63 years of age. The majority of patients were male. The device was implanted and will not return for analysis. Investigation is not complete. A follow-up report will be submitted with all relevant information. Literature : "2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy". The additional patient effects and the absorb scaffold referenced are being filed under a separate medwatch report number.
 
Event Description
It was reported through a research article identifying the absorb scaffold and xience stent may be related to target vessel myocardial infarction (mi), mi, device thrombosis, cardiac death, death, ischemia-driven target lesion revascularization, and restenosis specific patient information is documented as unknown. Details provided in the article titled: "2-year outcomes with the absorb bioresorbable scaffold for treatment of coronary artery disease: a systematic review and meta-analysis of seven randomised trials with an individual patient data substudy¿.
 
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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 (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 Key10094152
MDR Text Key192379973
Report Number2024168-2020-04539
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
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,Followup,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK XIENCE
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 Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/27/2020 Patient Sequence Number: 1
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