XIENCE Skypoint™ 1804300-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648231285), received between Apr 8, 2024 and Mar 4, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION, WHEN ATTEMPTING TO PLACE THE 3.00X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) ON THE GUIDE WIRE, THE STENT WAS TOUCHED AND THEN THE STENT DISLODGED FROM THE SDS. 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 24514357 ↗
• MalfunctionJan 29, 2026Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.00X48MM XIENCE SKYPOINT DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO CROSS DUE TO THE ANATOMY. UPON REMOVAL, RESISTANCE WAS MET WITH THE GUIDING CATHETER; THEREFORE, THE SDS AND GUIDING CATHETER WERE REMOVED AS ONE UNIT. A NEW UNSPECIFIED GUIDING CATHETER AND NEW 3.00X48MM XIENCE SDS WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. UPON TESTING OF THE REMOVED XIENCE SDS WITH BOTH GUIDING CATHETERS OUTSIDE THE ANATOMY, IT WAS NOTED THAT ONLY THE FIRST GUIDING CATHETER HAD AN ISSUE. 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 24213189 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI), HAD ONE XIENCE SKYPOINT (3.0X48 MM) STENT IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE (A PRE-EXISTING CONDITION) AND THROMBOSIS OF THE CARDIAC PROSTHESIS. THROMBUS WAS IN THE RIGHT CORONARY ARTERY. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21949881 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT MAIN (LM) TO LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5X38MM XIENCE SKYPOINT WAS IMPLANTED IN THE LAD TO LM. A 3.0X48MM XIENCE SKYPOINT STENT WAS IMPLANTED FOLLOWED BY INTRAVASCULAR LITHOTRIPSY (IVL) TREATMENT. UPON POST DILATATION OF THE SKYPOINT STENT WITH A 4.5MM NC BALLOON, IT WAS NOTED THE VESSEL RUPTURED. THE PHYSICIAN STATED THAT THE VESSEL WAS HIGHLY CALCIFIED, AND THE DIAMETER OF THE NC BALLOON WAS TOO LARGE. HEMOSTASIS WAS ATTEMPTED WITH NON-ABBOTT BALLOON CATHETER AND COVERED STENT BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO SURGERY. CORONARY ARTERY BYPASS GRAFT (CABG) WAS PERFORMED ALONGSIDE AN AORTIC STENOSIS (AS) AND AORTA ASCENDENS (AA) REPLACEMENT OPERATION. THE SURGERY WAS COMPLETED WITH NO ISSUES AND THE PATIENT IS CURRENTLY STABLE AND HOSPITALIZED IN THE ICU. THE PHYSICIAN STATED THAT THE POST-DILATION OF STENT IS LIKELY THE DIRECT CAUSE OF THE VESSEL PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 20941051 ↗
• MalfunctionSep 23, 2024Leak/Splash; Activation Failure; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE 3X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE IMPLANTED AT THE TARGET LESION; HOWEVER, THE STENT WAS NOT ABLE TO BE COMPLETELY DEPLOYED. THEREFORE, THE SDS WAS REMOVED AND BLOOD AND AIR WAS NOTED TO BE LEAKING FROM THE PROXIMAL SHAFT. 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 20281177 ↗
• MalfunctionApr 8, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTEYR THAT WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. WHEN THE XIENCE SKYPOINT DES 3.00 X 48 RX STENT WAS ATTEMPTED TO BE DEPLOYED, THE STENT WAS NOT EXPANDED WELL AT THE TARGET LESION DESPITE 12 ATM PRESSURE THAT WAS APPLIED. WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED (APPOSED), THE STENT BECAME PARTALLY BENT, SO THE STENT WAS NOT APPOSED CORRECTLY. THEREFORE, THE STENT WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER XIENCE STENT TO COMPLETE THE PROCEDURE. 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 19067954 ↗