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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 1804400-18
Device Problems Unintended System Motion (1430); Malposition of Device (2616); Difficult to Advance (2920)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/02/2021
Event Type  malfunction  
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. Additionally, a review of the complaint history identified no similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported unintended system motion/difficult to deploy and malposition of the stent; however, the reported difficult to advance appears to be related to the circumstances 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 tortuous proximal right coronary artery (prca). An unspecified guide catheter was advanced through the left radial; however, the device caused a dissection. The dissection was covered with an unspecified stent. The 4. 0x18mm xience skypoint was advanced even though resistance was met with anatomy. The stent was deployed, but watermelon seeded out of the lesion on the balloon and still on the wire to the aorta. The physician pulled back the stent delivery system with the stent to the radial artery and deployed the stent there. Access from the right groin was obtained and another 4x28mm unspecified stent was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay. 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 Key12849766
MDR Text Key283302950
Report Number2024168-2021-10669
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233487
UDI-Public08717648233487
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804400-18
Device Catalogue Number1804400-18
Device Lot Number1051941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
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: 11/20/2021 Patient Sequence Number: 1
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