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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT 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 Stroke/CVA (1770); Ischemia (1942); Myocardial Infarction (1969); Occlusion (1984); Stenosis (2263)
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative
Date of event and implant: estimated date. 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 effect(s) of myocardial infarction, cerebrovascular accident, occlusion, ischemia and stenosis are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effect(s) of coronary stenting procedures. A conclusive cause for the reported patient effect(s), 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.
 
Event Description
It was reported through a research article identifying xience and other non-abbott stents that may be related to the following; myocardial infarction, stroke, lesion occlusion, ischemia, stent restenosis, re-hospitalization, and target vessel revascularization (percutaneous intervention or coronary artery bypass grafting). Specific patient information is documented as unknown. Details are listed in the attached article, titled "long-term outcomes of three-vessel coronary artery disease after coronary revascularization by percutaneous coronary intervention using second-generation drug-eluting stents versus coronary artery bypass graft surgery".
 
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Brand NameXIENCE DRUG ELUTING CORONARY STENT
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 Key9862412
MDR Text Key187410505
Report Number2024168-2020-02751
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,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2020
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: 03/20/2020 Patient Sequence Number: 1
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