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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT CORONARY DRUG-ELUTING STENT

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ABBOTT VASCULAR INC. XIENCE SKYPOINT CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 1804225-18
Device Problems Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 11/10/2021
Event Type  malfunction  
Event Description
First stent deployed in rca (right coronary artery), attempted to deploy 2nd stent distal to first. Stent came off wire inside of first stent. 2nd stent left undeployed inside.
 
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Brand NameXIENCE SKYPOINT
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara CA 95054
MDR Report Key12868211
MDR Text Key281218929
Report Number12868211
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804225-18
Device Catalogue Number1804225-18
Device Lot Number1032441
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2021
Event Location Hospital
Date Report to Manufacturer11/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/24/2021 Patient Sequence Number: 1
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