XIENCE Skypoint™ 1804275-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08717648233159), received between Apr 6, 2022 and Feb 10, 2026 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY BUT THE 2.75X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DEVICE BECAME STUCK IN THE LEFT MAIN. THERE WERE 2 UNSPECIFIED STENTS IN THE ANATOMY FROM A PREVIOUS PROCEDURE THAT THE DEVICE BECAME STUCK WITH. THE PHYSICIAN YANKED THE DEVICE AND THE STENT CAME OFF OF THE DELIVERY SYSTEM AND IS LODGED BETWEEN THE TWO PREVIOUSLY IMPLANTED STENTS. THE PATIENT EXPERIENCED CHEST PAIN DURING THE PROCEDURE. THE PATIENT WAS SENT TO BYPASS. THE PATIENT WAS DISCHARGED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Foreign Body In Patient

  MAUDE report 24307361 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  SUBSQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THE LESION WAS THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 23977058 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID (B)(6). IT WAS REPORTED THAT THE LEFT HEART CATHETERIZATION PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION, WITH SEVERE 70 TO 75% STENOSIS, IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. CIRCUMFERENTIAL 360 DEGREE CALCIFICATION WAS CONFIRMED BY OPTICAL COHERENCE TOMOGRAPHY. INTRAVENOUS LITHOTRIPSY (IVL) WAS PERFORMED WITH THE ABBOTT IVL DEVICE. THERE WAS VERY GOOD RESULT WITH SOME PLAQUE SHIFT INTO THE DISTAL DIAGONAL BRANCH, BUT TIMI 3 FLOW WAS STILL GOOD INTO THIS DIAGONAL. THE 2.75 X 15 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE LAD, RESULTING IN VERY GOOD ANGIOGRAPHIC RESULTS. THE CASE MOVED ON TO THE SMALL DIAGONAL BRANCH, BUT THE BALLOON DILATATION CATHETER WAS UNABLE TO CROSS. AT THIS TIME, THE LAD STENT APPEARED TO BE DEVELOPING THROMBUS. A SECOND 3.0 X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE FIRST STENT, RESULTING IN TIMI 3 FLOW. THERE WAS NO RESIDUAL STENOSIS; HOWEVER, THE SMALL DIAGONAL BRANCH WAS LOST (OCCLUDED). AT THIS TIME, THE PATIENT REPORTED CHEST PAIN. THROMBUS WAS AGAIN NOTED IN THE LAD STENT. A THIRD 3.0 X 23 MM XIENCE SKYPOINT STENT WAS PLACED, SUCCESSFULLY TREATING THE THROMBOSED STENT. THE PATIENT WAS DOING WELL AND THE PROCED

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 22651734 ↗
• MalfunctionMay 13, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREP OF THE 2.75X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WHEN ATTEMPTING TO REMOVE THE STYLET, IT REMAINED STUCK ON THE STENT. THE STENT WAS NOTED TO STILLY REMAIN ON THE DELIVERY SYSTEM. ANOTHER SAME SIZE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 22012517 ↗
• InjuryFeb 2, 2024Adverse 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 ELEVATION MYOCARDIAL INFARCTION (STEMI) AND CHRONIC ISCHEMIC HEART DISEASE, HAD 1 XIENCE SKYPOINT (2.75X15MM) STENT IMPLANTED. ON (B)(6) 2023, THE PATIENT WAS RE-ADMITTED WITH CORONARY THROMBOSIS AND CARDIAC DISTURBANCES. THROMBECTOMY WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18631661 ↗
• InjuryJul 17, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THAT THE TWO UNSPECIFIED XIENCE STENTS WERE A 2.25X28MM XIENCE SKYPOINT THAT WAS DEPLOYED IN THE DIAGONAL AND A 2.75X33MM XIENCE SKYPOINT THAT WAS DEPLOYED IN THE LEFT ANTERIOR DESCENDING ARTERY.

  Patient problems: Embolism/Embolus

  MAUDE report 17334861 ↗
• InjuryAug 11, 2022Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE LESION WAS PRE-DILATATED WITH A 3MM NON-ABBOTT BALLOON AND A 2.75X15MM XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DESS) WAS ADVANCED TO THE TARGET LESION. THE DELIVERY SYSTEM BALLOON WAS INFLATED ONE TIME TO 12 ATMOSPHERES (ATM), AND THE STENT WAS IMPLANTED; HOWEVER, DUE TO THE CALCIFICATION, THE DELIVERY SYSTEM BALLOON RUPTURED. DURING REMOVAL, THE STENT DELIVERY SYSTEM BALLOON WAS CAUGHT WITH THE ANATOMY AND COULD NOT BE REMOVED WHICH RESULTED IN EKG CHANGES (ST-SEGMENT ELEVATION) FOR THE PATIENT. A GUIDE CATHETER (GC) WAS ADVANCED TO REMOVE THE DELIVERY SYSTEM AND THE EKG CHANGES RESOLVED. ANOTHER BALLOON WAS USED TO POST-DILATATE THE STENT WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 15214895 ↗
• MalfunctionJul 29, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT 90% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.75X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION WITH DIFFICULTY DUE TO THE ANATOMY BUT THE SDS FAILED TO REACH THE LESION; THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. IT WAS NOTED THE STENT MOVED ON THE DELIVERY SYSTEM BALLOON BUT DID NOT COMPLETELY BECOME DISLODGED AND REMAINED ON THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136424 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. THE 2.75X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO CROSS THE LESION; HOWEVER, FAILED DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 14979133 ↗
• InjuryMay 9, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES, "AN ELDERLY MALE IN CATH LAB: ABBOTT XIENCE SKYPOINT 2.75X15 DRUG ELUTING STENT INSERTED WOULD NOT CROSS THE LESION. UPON REMOVING THE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM, AND LEFT IN THE BODY. A 1.5 EMERGE BALLOON WAS PLACED IN THE BODY, INFLATED AND REMOVED THE DISLODGED STENT. PATIENT TO PACU IN STABLE CONDITION. PREPARING PATIENT NOW FOR DISCHARGE 1 DAY-POST PROCEDURE. STENT PLACEMENT DUE TO CORONARY ARTERY DISEASE INVOLVING NATIVE CORONARY ARETERY OF NATIVE HEART WITH ANGINA PECTORIS." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336965 ↗
• MalfunctionApr 19, 2022Positioning Problem

  AN ELDERLY MALE IN CATH LAB: ABOTT XIENCE SKYPOIKNT 2.75X 15 DRUG-ELUTING STENT INSERTED WOULD NOT CROSS THE LESION. UPON REMOVING THE STENT DELIVERY SYSTEM IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM, AND LEFT IN BODY. A 1.5 EMERGE BALLOON WAS PLACED IN THE BODY, INFLATED AND REMOVED THE DISLODGED STENT. PATIENT TO PACU IN STABLE CONDITION. PREPARING PATIENT NOW FOR DISCHARGE 1 DAY-POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14141068 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6)2021 THE PATIENT HAD A 2.75X15 MM XIENCE SKYPOINT STENT IMPLANTED. ON (B)(6)2021 THE PATIENT WAS RE-HOSPITALIZED DUE TO CHEST PAIN. THERE WAS NO TREATMENT PERFORMED AND THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 14022853 ↗