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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK RX XPEDITION
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)
Event Date 04/26/2016
Event Type  Injury  
Manufacturer Narrative
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 number was not provided. The reported patient effect(s) of stenosis, thrombosis, ischemia and myocardial infarction are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures. A conclusive cause for the reported stenosis, thrombosis, ischemia and myocardial infarction, and the relationship to the product, if any, cannot be determined. The treatment(s) 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. Attachment: " biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with st-segment elevation myocardial infarction (biostemi): a single-blind, prospective, randomised superiority trial¿.
 
Event Description
It was reported through a research article identifying the xience xpedition and xience alpine that may be related to target lesion failure, defined as a composite of cardiac death, target vessel myocardial reinfarction (mi) (q wave and non q-wave), clinically indicated target lesion revascularization, ischemia, and stent thrombosis within 12 months of the index procedure. Specific patient information is documented as unknown. Details are listed in the attached article, titled: " biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with st-segment elevation myocardial infarction (biostemi): a single-blind, prospective, randomised superiority trial. ¿.
 
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Brand NameXIENCE XPEDITION 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 Key9914119
MDR Text Key189077166
Report Number2024168-2020-03238
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSZ
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,Followup
Report Date 07/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK RX XPEDITION
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: 04/01/2020 Patient Sequence Number: 1
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