XIENCE Skypoint™ 1804325-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648233333), received between Jan 29, 2021 and Feb 11, 2026 — classified as 1 death, 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A XIENCE SKYPOINT 3.25X23 WAS INSERTED. HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT THROUGH THE GUIDE EXTENSION. THEREFORE, THE STENT WAS REMOVED. UPON REMOVAL, IT WAS OBSERVED THE STENT WAS NOT IN THE BALLOON. THE GUIDE EXTENSION WAS THEN REMOVED, AND THE STENT WAS FOUND INSIDE. AN ADDITIONAL XIENCE SKYPOINT WAS INSERTED AND DEPLOYED WITHOUT ISSUES. THERE WERE 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 24318704 ↗
• DeathMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5 TREK BALLOON DILATATION CATHETER (BDC) AND A NON-ABBOTT INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WERE USED TO PREPARE THE VESSEL, AFTER WHICH A 3.5X23MM SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED. VIA IMAGING, THE DISTAL END LOOKED HAZY. THROMBOSIS WAS NOTED. A 3.0 NC TREK BDC WAS USED. CARIOPULMONARY RESUSCITATION WAS STARTED BUT WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16569563 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.25 X 23 MM XIENCE SKYPOINT STENT WAS IMPLANTED. AFTER STENT IMPLANTATION, A PROXIMAL DISSECTION WAS SUSPECTED. AN ADDITIONAL XIENCE SKYPOINT STENT WAS IMPLANTED TO TREAT THE DISSECTION. AFTER THE PROCEDURE, A PERCLOSE PROGLIDE VESSEL CLOSURE DEVICE WAS USED TO CLOSE THE ACCESS SITE; HOWEVER, A CUFF MISS OCCURRED. HEMOSTASIS WAS ACHIEVED WITH USE OF A SECOND PROGLIDE. THERE WAS NO ADVERSE PATIENT SEQUALA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 15574739 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ON (B)(6) 2022 A 3.5X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE TO AN ACUTE MYOCARDIAL INFARCTION AND UNSPECIFIED SEPSIS. MEDICATION WAS PROVIDED AND NO ADDITIONAL PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Sepsis

  MAUDE report 15043509 ↗
• MalfunctionFeb 24, 2022Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND A 3.25X23MM XIENCE SKYPOINT WAS ATTEMPTED TO CROSS HOWEVER, FAILED TO CROSS AS IT MET RESISTANCE WITH A PREVIOUS IMPLANTED STENT WITH RESTENOSIS IN THE PROXIMAL END OF THE STENT. DURING REMOVAL RESISTANCE WAS MET WITH THE PREVIOUS IMPLANTED STENT AND THE XIENCE SKYPOINT STENT WAS NOTED TO BE FLARED. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON. THERE WAS 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 13595789 ↗
• MalfunctionJan 27, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. PRE-DILATATION WAS PERFORMED AND A 3.25X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TOWARDS THE TARGET LESION BUT COULD NOT CROSS THE ANATOMY. THE DEVICE WAS REMOVED, AND ADDITIONAL BALLOON DILATATION WAS PERFORMED; HOWEVER, THE DES STILL COULD NOT CROSS THE ANATOMY AFTER IT WAS RE-INSERTED AND ATTEMPTED TO CROSS AGAIN. THE DES WAS REMOVED A SECOND TIME, WITH RESISTANCE MET AND A NON-ABBOTT DEVICE WAS USED TO CROSS THE ANATOMY AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374586 ↗
• MalfunctionJul 20, 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 OBTUSE MARGINAL (OM) ARTERY THAT IS 100% STENOSED. A 3.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED DURING REMOVAL THE DEVICE MET RESISTANCE WITH ANATOMY. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197052 ↗
• MalfunctionJun 11, 2021Difficult 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 RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE MET WITH THE LESION DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987943 ↗
• MalfunctionJan 29, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX). A 3.25X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) AND A 3.0X23MM XIENCE SKYPOINT DES WERE ADVANCED AT THE SAME TIME INSIDE THE GUIDING CATHETER; HOWEVER, THE DEVICES BECAME STUCK. BOTH DES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11253267 ↗