XIENCE Skypoint™ 1804325-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648233340), received between Jun 21, 2021 and Jul 9, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Difficult to Remove; Material Separation; Packaging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25764564 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) HAD ONE XIENCE SKYPOINT (3.25X28 MM) STENT IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND STEMI. BALLOON ANGIOPLASTY / THROMBECTOMY WAS PERFORMED TO TREAT THE CONDITION. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ON 05/03/2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 19924053 ↗
• InjuryDec 20, 2023Patient-Device Incompatibility; Device Damaged by Another Device; Material Deformation; Patient-Device Incompatibility; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SHORT LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE VERSATURN GUIDE WIRE WAS ADVANCED. PRE-DILATATION WAS PERFORMED USING A 2.5X12 TREK RX BALLOON DILATATION CATHETER (BDC) FOLLOWED BY THE FIRST OPTICAL COHERENCE TOMOGRAPHY (OCT) RUN IN THE LAD. THE 3.25X28MMMM XIENCE SKYPOINT STENT WAS THEN IMPLANTED. THE 3.25X15MM NC TREK NEO BDC WAS USED FOR POST DILATATION, HOWEVER, THERE WAS RESISTANCE FELT AT THE PROXIMAL EDGE OF THE XIENCE SKYPOINT STENT, DUE TO THE BDC NOT BEING ABLE TO BEND THE CURVE OF THE VESSEL AND AFTER PUSHING SLIGHTLY WAS ABLE TO ADVANCE TO THE DISTAL PORTION OF THE STENT AND DILATATION WAS PERFORMED WITHOUT ISSUES. ANOTHER OCT RUN WAS PERFORMED TO CHECK THE PLACEMENT OF THE STENT AND UPON EVALUATION OF THE OCT IMAGE, IT WAS NOTED THAT THERE WAS SIGNIFICANT MALAPPOSITION OF THE STENT AND AN ABSENCE OF STENT STRUTS ON THE OPPOSING WALL WHICH WAS CONFIRMED IN THE LONGITUDINAL MODE DISPLAY DEMONSTRATING THAT 2 OF THE PROXIMAL STENT STRUTS WERE PROLAPSED ON ONE ANOTHER. THE OPPOSING WALL OF THE STENT HAD LIFTED FROM THE WALL CAUSING A >300 MICRON MALAPPOSITION. THE PHYSICIAN THEN DECIDED TO INFLATE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369650 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT, WITH A HISTORY OF ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) AND CHRONIC ISCHEMIC HEART DISEASE, HAD ONE XIENCE SKYPOINT (3.25X28MM) STENT IMPLANTED. ON (B)(6) 2023 THE PATIENT WAS RE-ADMITTED WITH ABNORMAL BLOOD CHEMISTRY AND WAS DISCHARGED ON (B)(6) 2023. THE PATIENT WAS RE-ADMITTED ON (B)(6)2023, WITH CHRONIC ISCHEMIC HEART DISEASE AND STENOSIS OF THE CORONARY STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)WAS PERFORMED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 18073124 ↗
• MalfunctionSep 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 LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 3.25X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED. RESISTANCE WAS FELT WITH THE HEAVILY CALCIFIED ANATOMY AND THE BES FAILED TO CROSS. THE DEVICE WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT DEVICE 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 12503035 ↗
• MalfunctionJul 15, 2021Difficult to Remove; Difficult to Remove

  SUBSEQUENT TO THE INITIAL REPORT, THE ADDITIONAL INFORMATION WAS OBTAINED: THE ISSUE OCCURRED WITH THE FIRST TWO XIENCE SKYPOINT STENT DELIVERY SYSTEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12177658 ↗
• MalfunctionJun 21, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. A 3.25X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND FACED RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT DEVICE 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 12036923 ↗