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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1125275-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Atrial Fibrillation (1729); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Ischemia (1942); Heart Failure (2206); Test Result (2695)
Event Date 11/08/2019
Event Type  Injury  
Manufacturer Narrative
The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that a percutaneous coronary intervention was performed on (b)(6) 2019. A 2. 75x18mm xience alpine stent was implanted in the proximal-mid left anterior descending (lad) coronary artery lesion and a 2. 5x12mm xience alpine stent was implanted in the mid lad. The procedure was performed without complications. Starting on (b)(6) 2019, the patient experienced acute on chronic heart failure. The patient was admitted to the hospital with dyspnea, orthopnea, and angina. Elevated troponin and the ejection fraction was observed at 50-55%. Reportedly, the elevated troponin was related to demand ischemia secondary to heart failure and atrial fibrillation. Medications were provided. On (b)(6) 2019, a non-abbott stent was implanted in the stenosed proximal lad, more proximal and slightly overlapping the previously implanted mid-proximal lad 2. 75x18mm xience alpine stent. Medications were also provided. Per physician, the events were unrelated to the xience alpine stents and unrelated to the index procedure. There was no device malfunction. The event resolved without sequela. There was no additional information provided regarding this issue.
 
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Brand NameXIENCE ALPINE 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 # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9935627
MDR Text Key187392697
Report Number2024168-2020-03476
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2020
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 Expiration Date05/04/2020
Device Model Number1125275-18
Device Catalogue Number1125275-18
Device Lot Number7041761
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 Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/05/2017
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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