XIENCE Skypoint™ 1804500-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648233630), received between Aug 2, 2022 and Nov 27, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS. AFTER IMPLANTING A 4.5X23MM XIENCE SKYPOINT STENT, A 5.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH A NON-ABBOTT GUIDE CATHETER; HOWEVER, BECAME STUCK IN THE GUIDING CATHETER AND COULD NOT BE REMOVED. THEREFORE, THE XIENCE SKYPOINT AND GUIDING CATHETER WERE REMOVED TOGETHER AS ONE UNIT. A 4.5X15MM XIENCE SKYPOINT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213185 ↗
• MalfunctionMay 24, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE MID AND PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH SEVERE CALCIFICATION. THE LESIONS WERE PRE-DILATED. A 5X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE PROXIMAL RCA LESION DUE TO THE ANATOMY AND THE STENT WAS DISLODGED BUT REMAINED ON THE SDS. THE DEVICE WAS REMOVED WITH RESISTANCE WITH A NON-ABBOTT GUIDE EXTENSION CATHETER. A SAME SIZED SDS WAS USED TO TREAT THE LESION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994764 ↗
• MalfunctionAug 2, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN (LM) ARTERY WITH 75% STENOSIS, NO CALCIFICATION AND NO TORTUOSITY. THE 5.0X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE AND FAILED TO CROSS DUE TO DEVICE INTERACTION WITH THE GUIDE WIRE. AFTER REMOVAL, AN ATTEMPT WAS MADE AND FAILED TO CROSS THE LESION AGAIN. THERE WAS RESISTANCE DURING REMOVAL WITH THE GUIDE WIRE. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION AND STENT DISLODGEMENT. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15148168 ↗