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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
Model Number 1074300-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Cardiac Enzyme Elevation (1838); Occlusion (1984); Ventricular Fibrillation (2130); Prolapse (2475)
Event Date 09/16/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. 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 effect(s) of ventricular fibrillation and occlusion are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. However, the treatment 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.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, the patient presented with in-stent restenosis with a chronic, total occlusion (100%) within the proximal right coronary artery (rca) lesion. Pre-dilatation was performed. Three 3. 0x38mm xience xpedition stents were implanted and a 3. 0x18mm xience xpedition stent was implanted without a device issue reported. Timi flow 3 and 0% residual stenosis was observed. Plaque shift had occurred within a xience stent and the side branch was lost. The side branch was attempted to be re-crossed unsuccessfully. The patient had gone into ventricular fibrillation, treated with cardioversion. During oct imaging, the patient went into cardiac arrest. The patients rhythm returned to normal sinus and the event resolved. Elevated cardiac enzymes were also observed without any treatment reported and without any new myocardial infarction (mi) diagnosed. Reportedly, the elevated enzymes were likely due to cardiac arrest along with loss of a side branch. The patient was kept overnight for observation. There was no device malfunction. No additional information was provided regarding this issue.
 
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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 Key10656302
MDR Text Key210650735
Report Number2024168-2020-08433
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCA
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
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1074300-38
Device Catalogue Number1074300-38
Device Lot Number9080141
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 Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/09/2020 Patient Sequence Number: 1
Treatment
3 IMPLANTED XIENCE XPEDITION STENTS
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