XIENCE Skypoint™ 1804450-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648233562), received between Feb 16, 2023 and Dec 30, 2025 — classified as 3 injuries, 2 malfunctions.

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

• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2023 ONE 4.5X18 MM XIENCE SKYPOINT LV (LOT 2030141) WAS IMPLANTED IN THE LEFT MAIN CORONARY ARTERY AND ONE 3.0X33 MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2023, THE PATIENT, WHO HAS A HISTORY OF CONGESTIVE HEART FAILURE, WAS RE-ADMITTED TO THE HOSPITAL WITH ACUTE ON CHRONIC HEART FAILURE. AFTER THE PATIENT WAS OBSERVED, THE PATIENT WAS DISCHARGED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23921344 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON 12/05/2022 THE PATIENT HAD A 4.5X18 MM XIENCE SKYPOINT LV STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2024 DURING A CARDIO WORKOUT, THE PATIENT BEGAN EXPERIENCING CHEST PAIN. THE PATIENT CAME TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND WAS ADMITTED FOR OBSERVATION. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. ALTHOUGH THE LABS, ELECTROCARDIOGRAM AND ECHOCARDIOGRAM WERE NORMAL, THE PATIENT WAS TOLD TO FOLLOW UP WITH PRIMARY CARDIOLOGY. CARDIAC CATHETERIZATION PERFORMED ON (B)(6) 2024 SHOWED MILD STENOSIS (20%) IN THE LAD. THE PATIENT WAS TOLD TO CONTINUE MEDICAL MANAGEMENT WITH PRIMARY CARE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 21208309 ↗
• InjuryApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS SAPHENOUS VEIN GRAFT TO OBTUSE MARGINAL (SVG TO OM). THE 4.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DISLODGED WHEN ADVANCING THROUGH AN UNSPECIFIED GUIDE CATHETER. THE STENT WAS RETRIEVED VIA SNARE WITH AN UNSPECIFIED BALLOON. A SECOND 4.5X18MM XIENCE SKYPOINT (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY. THEREFORE A 4.0 NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE 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 19092985 ↗
• MalfunctionMay 11, 2023Break; Activation Failure; Break; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.50X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE TARGET LESION; HOWEVER, THE DELIVERY SYSTEM BALLOON WOULD NOT INFLATE, AND THE STENT COULD NOT BE DEPLOYED. ONCE OUTSIDE THE PATIENT ANATOMY, THE DELIVERY SYSTEM WAS INSPECTED, AND THE HUB APPEARED TO BE CRACKED, HOWEVER THERE WERE NO DEVICE LEAKS OR SEPARATIONS THAT OCCURRED. A NEW 4.5X18MM XIENCE SKYPOINT DES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913493 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). TWO STENTS, A 4.50X18MM, AND A 4.0X18MM XIENCE SKYPOINT DRUG ELUTING STENTS (DES) COULD NOT BE ADVANCED THROUGH THE NON-ABBOTT GUIDE EXTENSION CATHETER AND DISLODGED OUTSIDE THE PATIENT ANATOMY INSIDE OF THE GUIDE EXTENSION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW, 4.5X18MM SKYPOINT DES WAS ABLE TO BE DELIVERED THROUGH A NEW NON-ABBOTT GUIDE EXTENSION CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391603 ↗