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

Model Number 1804350-15

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

Stent went in the body in left main, not able to cross to circumflex, doctor pulled stent deployment system out, notices the stent was missing, under fluoro the stent was in the left main artery.Doctor was able to remove it under fluoro with a tulip snare.This caused the stent to pull out an existing left main stent that had been deployed early in the procedure.Stent went in the body, came out undeployed.Doctor noticed a stent defect.No patient harms was noted.

• Brand Name: XIENCE SKYPOINT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez road; temecula CA 92591
• MDR Report Key: 15713672
• MDR Text Key: 302839158
• Report Number: 15713672
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1804350-15
• Device Catalogue Number: 1804350-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2022
• Date Report to Manufacturer: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Male