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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE V 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)
Event Date 12/17/2017
Event Type  Injury  
Manufacturer Narrative
Event estimated dates. Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. The device was not returned for evaluation. A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided. The reported patient effects of myocardial infarction, thrombosis and ischemia are listed in the xience v everolimus eluting coronary stent systems instructions for use 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. However, the treatment appears 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. The additional adverse patient effect of death is being filed under a separate medwatch report #. Attachment: 2-year clinical outcomes of an abluminal groove¿filled biodegradable-polymer sirolimus-eluting stent compared with a durable-polymer everolimus-eluting stent.
 
Event Description
Details are listed in the attached article, titled ¿2-year clinical outcomes of an abluminal groove¿filled biodegradable-polymer sirolimus-eluting stent compared with a durable-polymer everolimus-eluting stent". It was reported through a research article identifying xience stents that may be related to the following: target vessel myocardial infarction, ischemia, very late stent thrombosis, target vessel/lesion revascularization, and non-cardiac/cardiac deaths. No additional information was provided.
 
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Brand NameXIENCE V 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 Key9924696
MDR Text Key189360204
Report Number2024168-2020-03377
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
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
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 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: 04/03/2020 Patient Sequence Number: 1
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