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

Model Number 1804300-28

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 12/22/2023

Event Type  malfunction  

Event Description

Per cardiac catheterization note - i attempted to cross the blockage with xience skypoint¿ stent however it would not cross.While it was being retrieved, stent came off the balloon in the proximal circumflex.There was still thrombolysis in myocardial infarction (timi) 3 flow however at this point.I focused to cross the stent struts against the vessel wall.Multiple wires, balloon and support catheters were used including pilot, fielder, run-through, whisper along with turnpike versus small support balloons but i could not cross beyond this segment.Patient was having active pain for which i decided to stabilize left main into left anterior descending artery (lad).3.5 x 30 onyx stent was then deployed from mid left main into proximal lad.Same stent balloon was used for post dilation of this stented segment.Further postdilation was done using 4.0 noncompliant balloon in left main and proximal lad.I attempted to rewire the circumflex with the stent struts, and i was able to get through the proximal stent where i had a 2.0 balloon to open up stent struts.I could still not go beyond mid circumflex where stent had dislodged.I decided to accept this result as further attempts were likely going to be unsuccessful.Impella was weaned off.Brilinta had been loaded and will be continued.Impella was removed.Preclose's were deployed and patent hemostasis was achieved.The patient tolerated the procedure well and left the cardiac catheterization laboratory pain-free and stable condition where he was taken back to an electrocardiographic a monitored site.

• Brand Name: XIENCE SKYPOINT¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; one lillehei plaza; saint paul MN 55117
• MDR Report Key: 18685245
• MDR Text Key: 335125358
• Report Number: 18685245
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1804300-28
• Device Catalogue Number: 1804300-28
• Device Lot Number: 2101341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR