XIENCE Skypoint™ 1804275-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08717648233203), received between Jul 27, 2021 and Dec 16, 2025 — classified as 6 injuries, 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 2.75X38MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGING, THE PROTECTIVE SHEATH WAS REMOVED AND THE STENT WAS NOTED TO BE LOOSE ON THE BALLOON AND COMING OFF. 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 23815943 ↗
• InjuryOct 24, 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 HAD ONE XIENCE SKYPOINT (2.75X38 MM) STENT IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND UNSTABLE ANGINA. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY OF THE STENT WAS PERFORMED. PATIENT DISCHARGE TO HOME ON (B)(6) 2024. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina

  MAUDE report 20522079 ↗
• MalfunctionOct 3, 2024Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL ARTERY. THROUGH THE SAME GUIDE CATHETER A 2.75X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) AND AN UNSPECIFIED BALLOON. DURING ADVANCEMENT OF THE SDS RESISTANCE WAS NOTED WITH THE GUIDE CATHETER AND WHEN ATTEMPTING TO INFLATE THE BALLOON OF THE SDS, THE BALLOON FAILED TO INFLATE AND A BALLOON RUPTURE OF THE SDS WAS THOUGHT TO HAVE OCCURRED. THE STENT FAILED TO DEPLOY; THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. ANOTHER 2.75X38MM XIENCE SKYPOINT STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NOT ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363892 ↗
• InjurySep 11, 2024Patient-Device Incompatibility; Difficult to Advance; Patient-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE RIGHT CORONARY ARTERY (RCA) WAS CLOSED AND THE LEFT ANTERIOR DESCENDING (LAD) WAS HEAVILY CALCIFIED. A 2.5X12MM UNSPECIFIED BALLOON WAS USED; HOWEVER DID NOT PRODUCE RESULTS THEREFORE, SHOCKWAVE WAS PERFORMED AND WAS ABLE TO MOVE THE BALLOON MORE DISTAL. A 2.75X38MM XIENCE SKYPOINT WAS ADVANCED AND IT WAS NOTED PATIENT WAS ON IMPELLA. EJECTION FRACTION WAS WASN'T GOOD, PATIENT WAS VERY SICK. THE STENT WAS DEPLOYED; HOWEVER, DISTAL PORTION OF STENT WAS NOT FULLY APPOSED DUE TO THE HEAVY CALCIUM. A 2.5X15 NON-COMPLIANT BALLOON WAS USED TO TRY TO OPEN UP THE STENT WHERE IT DID NOT EXPAND, BUT WAS UNSUCCESSFUL. A 3.0 UNSPECIFIED BALLOON WAS USED WITH A HIGHER PRESSURE, AROUND 16 ATMOSPHERES (ATMS), THEN WENT WITH 3.5 NON-COMPLIANT BALLOON AND INFLATED TO 16 ATMS AGAIN AND STENT EXPANDED. PERFORATION WAS OBSERVED AND PRESSURE STARTED DROPPING, WHICH EPINEPHRINE AND LEVOPHED DRIPS WERE GIVEN. PATIENT STILL ON IMPELLA AND TOOK ANOTHER BALLOON FOR PERFORATION, DID TAMPONADE, HELD PRESSURE WITH BALLOON FOR A COUPLE MINUTES. THE UNSPECIFIED GUIDE CATHETER WITH UNSPECIFIED GUIDE WIRE SLIPPED OUT AS THE GUIDE CATHETER TILTED UPWARDS AND THE VESSEL WAS MORE DOWNWARD TRA

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 20192933 ↗
• MalfunctionFeb 7, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.75X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON DID NOT INFLATE TO 8 ATMOSPHERES (ATM). THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660578 ↗
• MalfunctionJan 8, 2024Difficult 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 DISTAL RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, HEAVILY TORTUOUS AND 90% STENOSED. THE XIENCE SKYPOINT DES 2.75 X 38 RX US FAILED TO CROSS EVEN WITH USE OF THE EXTENSION CATHETER, SO A NEW, DIFFERENT SIZE XIENCE WAS USED TO COMPLETE THE PROCEDURE. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. 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 18465404 ↗
• MalfunctionOct 30, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. DURING ATTEMPTED DEPLOYMENT OF THE 2.75X38MM XIENCE SKYPOINT STENT, PRESSURE WAS APPLIED, BUT THE STENT BALLOON COULD NOT BE EXPANDED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035914 ↗
• MalfunctionMay 12, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.75X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924388 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 2.75X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED WITHOUT ISSUE IN THE MILDLY CALCIFIED, MODERATELY TORTUOUS,100% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2023, THREE DAYS POST STENT IMPLANTATION, THE PATIENT PRESENTED WITH CHEST PAIN AND THROMBOSIS WAS NOTED AT THE SKYPOINT STENT VIA IMAGING. TWO ADDITIONAL, LARGER SKYPOINT STENTS WERE IMPLANTED AS TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 16560850 ↗
• InjuryOct 19, 2022Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE NON-CALCIFIED, NON TORTUOUS DIAGONAL CORONARY ARTERY. THREE GUIDE WIRES AND THE 2.75X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WERE ALL ADVANCED AT THE SAME TIME THROUGH A 7FR SHEATH; HOWEVER, THERE WAS NO RESISTANCE REPORTED. DEPLOYMENT OF THE STENT WAS ATTEMPTED AND THE DISTAL SHAFT SEPARATED. THERE WAS NO RESISTANCE DURING REMOVAL. A SNARE WAS USED TO RETRIEVE THE DISTAL PORTION OF THE SHAFT AND THE UNDEPLOYED STENT TOGETHER. THE LESION WAS RE-WIRED AND A NEW, SAME SIZE SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636094 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). ON (B)(6) 2021, THE PATIENT HAD 2.75X38MM XIENCE SKYPOINT IMPLANTED AT 16 ATMOSPHERES WITH NO ISSUES. IN (B)(6) 2022, V4,5 AND TERMINAL T INVERSION WAS NOTED ON THE CARDIAC ELECTROGRAM DURING HOSPITALIZATION. ON (B)(6) 2022, A 1 YEAR FOLLOW-UP CORONARY ANGIOGRAM WAS PERFORMED AND IN-STENT RESTENOSIS WAS NOTED. REVASCULARIZATION WAS PERFORMED TO TREAT THE RESTENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes; Stenosis

  MAUDE report 15224602 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH NO CALCIFICATION AND NO TORTUOSITY. ON (B)(6) 2021, TWO STENTS WERE IMPLANTED, A 2.75X38MM AND A 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS). ONE STENT WAS IMPLANTED ON THE RIGHT DISTAL RCA AND ANOTHER STENT ON THE MID TO PROXIMAL RCA. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL AND IT WAS OBSERVED THAT BOTH IMPLANTED STENTS HAD BECOME COMPLETELY OCCLUDED AND THROMBOSIS WAS CONFIRMED. TWO ADDITIONAL STENTS WERE USED TO TREAT THE OCCLUSION. ANGIOGRAPHY WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14288889 ↗
• MalfunctionApr 11, 2022Difficult to Remove; Failure to Advance; Material Twisted/Bent; Difficult to Remove; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 100% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.75X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM SOMETHING UNKNOWN. THE DES COULD NOT REACH THE TARGET LESION AND UPON REMOVAL FROM THE ANATOMY, DIFFICULTY WAS MET AND THE SHAFT WAS BENT UP. IT IS UNKNOWN WHAT MAY HAVE CAUSED THE DAMAGE TO THE SHAFT OR HOW IT BECAME DAMAGED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. TWO NON-ABBOTT STENTS WERE THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075141 ↗
• MalfunctionSep 17, 2021Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. A 2.75X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED PER THE INSTRUCTIONS FOR USE WITHOUT ISSUES. THE SDS WAS ADVANCED WITHOUT ISSUES; HOWEVER, BLOOD IN THE HYPOTUBE WAS NOTED POSSIBLY INDICATING A LEAK. THE SDS WAS REMOVED WITHOUT ISSUES. ONCE OUTSIDE THE PATIENT ANATOMY UNSPECIFIED PRESSURE WAS APPLIED AND A PINHOLE AT THE PROXIMAL BALLOON WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.75X38MM XIENCE SKYPOINT STENT. 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 12488687 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND NO TORTUOSITY. THE 2.75X38 MM XIENCE SKYPOINT STENT HAD BEEN DEPLOYED WITH 2 INFLATIONS TO 12 ATMOSPHERES (ATM) AND NEGATIVE PRESSURE WAS HELD FOR 3-5 SECONDS TO DEFLATE THE BALLOON. THE BALLOON OF THE DELIVERY SYSTEM WAS STUCK TO THE STENT. THE BALLOON WAS RE-INFLATED AND PULLED TO NEGATIVE AGAIN AND WIGGLED AGGRESSIVELY AND IT WAS ABLE TO DISENGAGE FROM THE STENT AND BE REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12226549 ↗