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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1804350-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Thrombosis/Thrombus (4440)
Event Date 09/08/2021
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 effects of angina and thrombosis are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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; however, the reported 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
It was reported that the procedure was to treat a heavily calcified, 100% stenosed lesion in the left anterior descending (lad) artery. One-hour post deployment of a 3. 5x28mm xience skypoint drug eluting stent (des), the patient was on the recovery floor when he experienced chest pain. The patient was taken to the cath lab and imaging was performed showing a thrombosis at the implanted stent. A device was used to aspirate the in-stent thrombosis. When the device was removed from the anatomy, it was noted that it did not remove the clot but pushed it distally. Subsequently, the patient was fine and moved back to the recovery floor with no further intervention required. There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy. No additional information was provided.
 
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Brand NameXIENCE SKYPOINT DRUG ELUTING CORONARY 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 Key12529977
MDR Text Key273312782
Report Number2024168-2021-08579
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1804350-28
Device Catalogue Number1804350-28
Device Lot Number1051741
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 Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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