XIENCE Skypoint™ 1804450-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648233593), received between Mar 4, 2024 and Jan 6, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Difficult to Remove; Stretched; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE TORTUOSITY OF THE VESSEL. ON PULL BACK, THE SDS CAUGHT ON A PREVIOUSLY IMPLANTED STENT IN THE ILIAC ARTERY. THE XIENCE SDS WAS ABLE TO BE REMOVED FROM THE ILIAC STENT BUT IT WAS STRETCHED AND PULLED PAST THE BALLOON BUT REMAINED ON THE SYSTEM. THE STENT WAS REMOVED ON THE SYSTEM WHEN THE SDS WAS REMOVED. A NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 23977682 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT STENTING IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE 4.5X33MM XIENCE SKYPOINT STENT. UPON THE STENT ENTERING THE ANATOMY, THE PATIENT EXPERIENCED HYPOTENSION AND AFTER THE STENT WAS IMPLANTED THE PATIENT HAD BRADYCARDIA. MEDICATION AND INTRAVENOUS FLUIDS WERE GIVEN FOR HYPOTENSION AND FOR BRADYCARDIA. THE CONDITION RESOLVED ON (B)(6) 2023. THERE WAS NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 18827904 ↗