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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 Insufficient Information (3190)
Patient Problems Myocardial Infarction (1969); Thrombosis (2100)
Event Date 08/01/2014
Event Type  Injury  
Manufacturer Narrative
Estimate date of event. Estimated date of implant. The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The malfunctions referenced are being filed under a separate medwatch report number. The additional absorb device referenced is being filed under a separate medwatch report number. Literature: the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trial.
 
Event Description
It was reported through a research presentation identifying absorb bvs and xience stents that may be related to the following: myocardial infarction, thrombosis, revascularization, rehospitalization. Deployment difficulty was also noted for both absorb bvs and xience stents. This article summarizes clinical outcomes of 1,845 patients that were treated with xience stents. Specific patient information is documented as unknown. Details are listed in the article, titled "the relationship of pre-procedural dmax based sizing to lesion level outcomes in absorb bvs and xience ees treated patients in the aida trial. ".
 
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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 Key10780326
MDR Text Key214428296
Report Number2024168-2020-09192
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,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
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 Received11/09/2020
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: 11/03/2020 Patient Sequence Number: 1
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