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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE XPEDITION 48 STENT DELIVERY SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070350-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100); Test Result (2695)
Event Date 09/03/2020
Event Type  Injury  
Manufacturer Narrative
The stent remains implanted and will not return for evaluation. The 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 on (b)(6) 2020, the patient presented with elevated cardiac enzymes and a proximal left anterior descending (lad), 90% stenosed lesion. Predilatation was performed in the lad and a 3. 5x48mm xience xpedition stent was implanted more distal and a 4. 0x18mm xience sierra stent was implanted more proximal in the lad. Stent placement was deemed acceptable, with 0% diameter stenosis and no complications. On (b)(6) 2020, the patient had a subarachnoid hemorrhage after a fall. Due to the hemorrhage, the patient's antiplatelet medications xarelto and aspirin were held. Per physician, the fall and hemorrhage was unrelated to the xience device and index procedure. On (b)(6) 2020, the patient had chest pain, elevated cardiac enzymes were noted and a new st elevated myocardial infarction (stemi) was diagnosed. Late stent thrombosis with 100% occlusion was observed in the xience xpedition 3. 5x48mm stent in the lad reportedly, there was no thrombosis in the xience sierra 4. 0x18mm stent. As treatment for the thrombus, a new percutaneous coronary intervention was performed in the lad. Aspirin and heparin were started. On (b)(6) 2015, a left atrial appendage closure was performed to avoid long term anticoagulation after the intracranial hemorrhage. On (b)(6) 2020, per echocardiogram, the patient's left ventricular ejection fraction was down to 20%. Reportedly, there was no device malfunction. No additional information was provided regarding this issue.
 
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Brand NameXIENCE XPEDITION 48 STENT DELIVERY 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 Key10645396
MDR Text Key210382154
Report Number2024168-2020-08359
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 foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1070350-48
Device Lot Number9072441
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 Received10/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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: 10/07/2020 Patient Sequence Number: 1
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