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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 1070400-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Hypersensitivity/Allergic reaction (1907)
Event Date 10/15/2021
Event Type  Injury  
Event Description
It was reported that the patient had a xience xpedition stent implanted in the left anterior descending (lad) coronary artery on (b)(6) 2021.The patient returned the week of (b)(6) 2021 to further assess the downstream bifurcation lesion but now has aneurysmal vessel around the stent.On intravascular ultrasound (ivus), there is a black echo-lucent space between the stent struts and the adventitia.This extends throughout the length of the stent, not just the aneurysmal section.There is potential the patient has an allergy to polymer.No treatment has been performed but the aneurysm will be monitored.No additional information was provided.
 
Manufacturer Narrative
Estimated date.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of aneurysm and hypersensitivity are listed in the xience xpedition 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG 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 Key12759437
MDR Text Key282772952
Report Number2024168-2021-10019
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeNZ
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/06/2022
Device Catalogue Number1070400-15
Device Lot Number9053041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/15/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received11/08/2021
Supplement Dates FDA Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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