XIENCE Skypoint™ 1804325-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648233364), received between Sep 22, 2021 and Apr 18, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND THE PROCEDURE WAS TO TREAT A LESION IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIUM AND MODERATE TORTUOSITY. LITHOTRIPSY WAS PERFORMED. TWO XIENCE SKYPOINT STENTS, 3.25X38MM (DISTAL PART OF THE LAD) AND THEN 4.0X38MM (MID PORTION OF THE LAD), WERE IMPLANTED. STENTS WERE POST DILATATED PER STANDARD PROCEDURE AND INTRAVASCULAR ULTRASOUND (IVUS) IMAGING WAS OBTAINED POST STENT DILATATION. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS TAKEN BACK TO THE ROOM; HOWEVER, ABOUT 30-45 MINUTES LATER, THE PATIENT COMPLAINED ABOUT CHEST PAIN. AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED AND SHOWED ANTERIOR MYOCARDIAL INFARCTION (MI) ON THE EKG. THE PATIENT WAS BROUGHT BACK TO THE LAB AND AFTER PERFORMING THE ANGIOGRAM THE 3.23X38 STENT WAS NOTED TO BE BLOCKED OFF. IT WAS DETERMINED THAT THE STENT 100% THROMBOSED AND HAD TO BE OPENED. IN THE LAB, THE PATIENT NEEDED CPR SO THE PATIENT WAS INTUBATED AND IMPELLA DEVICE WAS INSERTED TO PROVIDE SUPPORT. A COUPLE DAYS LATER THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. NO ADDITIONAL

  Patient problems: Angina; Cardiac Arrest; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 19139866 ↗
• MalfunctionFeb 7, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED SUCCESSFULLY, HOWEVER, POST PROCEDURE,IT WAS NOTED THAT THE STENT WAS EXPIRED. THERE WAS NO ADVERSE PATIENT EFFECT 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 18664296 ↗
• MalfunctionJul 5, 2023Difficult 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 CIRCUMFLEX (LCX) ARTERY THAT WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. A 3.25X38MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE LESION IN LCX, BUT IT FAILED TO CROSS. THERE WAS ALSO RESISTANCE DURING REMOVAL OF THE DEVICE. AFTER ADDITIONAL PRE-DILATATION OF THE LESION, A NEW STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. 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 17262760 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED DE NOVO DISTAL RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. A 3.25X38MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY, AND DURING REMOVAL RESISTANCE WAS ALSO MET WITH ANATOMY. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO 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 12955984 ↗
• InjurySep 22, 2021Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED VESSEL IN THE LEFT CIRCUMFLEX (LCX) ARTERY. THE 3.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND JAMMED [ADVANCED AGAINST RESISTANCE] SEVERAL TIMES AGAINST THE HEAVY CALCIFICATION, CAUSING THE STENT TO DISLODGE. THE STENT WAS HANGING IN THE SHEATH; THE STENT [SDS] WAS MANIPULATED AND THE STENT CAME OFF THE SHEATH AND INTO THE FEMORAL ARTERY. THE STENT WAS RETRIEVED BY A SNARE DEVICE INTO THE GUIDING CATHETER AND THE STENT AND GUIDING CATHETER WERE REMOVED TOGETHER. THE LESION WAS PRE-DILATATED WITH A 3.0X25 NC TREK AND ANOTHER SAME SIZE XIENCE SKYPOINT COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12515695 ↗