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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 Intimal Dissection (1333); Thrombosis (2100); Prolapse (2475)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
Date of event: date is estimated. The unique device identifier (udi) is unknown because the part and lot numbers were not provided. Date of implant is estimated. The devices were not returned for analysis. A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided. The reported patient effects of intimal dissection, thrombosis and prolapse are listed in the xience everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The malposition of the stent referenced and in the attached article is filed under another mfr report number. Attachment: literature: early vascular responses to everolimus-eluting cobalt¿chromium stent in the culprit lesions of st-elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (mechanism-ami 2-week follow-up study).
 
Event Description
It was reported through a research article identifying xience family stents that may be related to the following: thrombosis, plaque prolapse, dissection and malposition of the stent. This article summarizes clinical outcomes of 52 patients that were treated with unspecified xience family stents. Specific patient information is documented as unknown. Details are listed in the attached article, titled "early vascular responses to everolimus eluting cobalt¿chromium stent in the culprit lesions of st elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (mechanism ami 2 week follow up study)".
 
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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 Key11174795
MDR Text Key227005759
Report Number2024168-2021-00466
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
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 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
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 Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/14/2021 Patient Sequence Number: 1
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