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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 Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)
Event Date 12/14/2013
Event Type  Injury  
Manufacturer Narrative
The udi is unknown because the part number and lot number were not provided. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. It should be noted that the reported patient effect(s) of myocardial infarction, thrombosis, and ischemia are listed in the xience v everolimus eluting coronary stent systems instructions for as a known patient effect(s) of coronary stenting procedures. A conclusive cause for the reported patient effect(s) of myocardial infarction, ischemia and thrombosis, 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. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. Literature: ¿safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the target ii trial. ¿.
 
Event Description
It was reported through a research article identifying the xience v may be related to death, target vessel myocardial infarction (mi), ischemia driven target lesion revascularization, and stent thrombosis. Specific patient information is documented as unknown. Details are listed in the article, titled: ¿safety and efficacy of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent for the treatment of de novo coronary lesions: 12-month results from the target ii 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 Key9939060
MDR Text Key189476367
Report Number2024168-2020-03512
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
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 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
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 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: 04/08/2020 Patient Sequence Number: 1
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