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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK RX PRIME
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Prolapse (2475); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Event Date 04/01/2014
Event Type  Injury  
Manufacturer Narrative
Attached article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs. Stable coronary artery disease. " event date: the date of occurrence is estimated. Udi: the udi number is ¿ni¿ as the catalog number was not provided. The xience xpedition is filed under a separate medwatch report number. 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. The reported patient effects of thrombosis and dissection are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures. Based on the information reviewed, a conclusive cause for the reported wall apposition and patient effects could not be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
The study investigated vascular response occurring at 3 months after xience prime and xience xpedition everolimus-eluting cobalt-chromium stent implantation in patients with st-segment elevation myocardial infarction versus stable coronary artery disease. The following complications were noted: uncovered stent struts and mal-apposed stent struts related to intrastent thrombus, irregular protrusion and edge dissection. Specific patient information is documented as unknown as this is from an article summary. Details are listed in the attached article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs. Stable coronary artery disease. ".
 
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Brand NameXIENCE PRIME 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 Key13831420
MDR Text Key287577154
Report Number2024168-2022-02881
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX PRIME
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
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: 03/20/2022 Patient Sequence Number: 1
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