XIENCE Skypoint™ 1804400-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648233456), received between Jul 19, 2021 and Oct 22, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Migration; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT MAIN CORONARY ARTERY WITH MILD CALCIFICATION AND WHERE A PREVIOUSLY IMPLANTED, UNSPECIFIED STENT, WAS LOCATED. THE 4.0X8MM XIENCE SKYPOINT STENT WAS DEPLOYED TO OVERLAP THE IMPLANTED STENT; HOWEVER, THE OVERLAP WAS MISSED BY 1MM. THE IMPLANTED STENT REMAINED WITHIN THE TARGET LESION AND NOT IN HEALTH TISSUE. POST-DILATION WAS PERFORMED WITH AN UNSPECIFIED 4.5X08 NON-COMPLIANT BALLOON WITHOUT ISSUE. INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN USED, NOTING THAT THE STENT HAD MIGRATED OVER THE TOP OF THE GUIDING CATHETER AND INTO THE FEMORAL ARTERY WHERE IT REMAINED. AN UNSPECIFIED STENT WAS IMPLANTED IN THE TARGET LESION. ADDITIONAL HOSPITALIZATION OCCURRED FOR VASCULAR SURGERY TO REMOVE THE MIGRATED STENT BY CUT DOWN. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507179 ↗
• MalfunctionJul 15, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 4.00X08MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED, BUT MET RESISTANCE AND FAILED TO REACH THE LESION. DURING REMOVAL OF THE DEVICE, RESISTANCE WAS MET, BUT THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032908 ↗
• MalfunctionApr 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 4.0 X 8 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) , WHEN THE STYLET WAS PULLED OUT OF THE SDS, THE STYLET WAS NOTED TO BE BROKEN IN TWO PIECES. THEREFORE, THE SDS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207421 ↗
• MalfunctionJul 19, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 100% STENOSED. A 4.0X08MM XIENCE SKYPOINT WAS ATTEMPTED TO BE ADVANCE; HOWEVER, MET RESISTANCE WITH ANATOMY. IT WAS NOTED DURING REMOVAL RESISTANCE WAS ALSO MET WITH ANATOMY. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. SUBSEQUENTLY AFTER INITIAL WAS FILED IT WAS CONFIRMED THE DEVICE FAILED TO CROSS DUE TO ANATOMY AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193207 ↗