XIENCE Skypoint™ 1804450-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648233579), received between Aug 3, 2022 and Mar 31, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Leak/Splash; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS A 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.5 X 23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, BUT RESISTANCE WAS MET WITH THE ANATOMY. THEREFORE, A GUIDE EXTENSION CATHETER WAS USED. HOWEVER, AS THE GUIDE EXTENSION CATHETER WAS NOT IN SPECIFICATION FOR COMPATIBILITY WITH THE SDS, FORCE WAS APPLIED THE PUSH THE STENT THROUGH THE GUIDE EXTENSION CATHETER. THEN AT THE TARGET LESION, THE BALLOON WAS ATTEMPTED TO BE INFLATED TO DEPLOY THE STENT; HOWEVER, THE BALLOON WOULD NOT INFLATE, AND NO PRESSURE WAS ABLE TO BE HELD. A LEAK WAS NOTED TO BE AT THE PROXIMAL END. THE SDS WAS REMOVED FROM THE PATIENT AND A 4.0 MM XIENCE SKYPOINT STENT WAS USED TO CONTINUE THE PROCEDURE. 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 24747065 ↗
• MalfunctionAug 12, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). REPORTEDLY A 1.33MM NON-ABBOTT GUIDING CATHETER (GC) WAS USED TO DELIVER A UNKNOWN BALLOON DILATATION CATHETER (BDC). FOLLOWING DILATION OF THE LESION, A 4.50X23MM XIENCE SKYPOINT RX DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER IT BECAME STUCK IN THE GC. BOTH THE GC AND DES WERE REMOVED INDEPENDENTLY, AND A NEW SKYPOINT DES WAS USED TO 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 19962074 ↗
• MalfunctionAug 3, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN OSTIAL LEFT MAIN TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.5X23MM XIENCE SKYPOINT WAS ATTEMPTED TO BE DELIVERED BUT FAILED TO CROSS DUE TO THE STENT IMPLANT GETTING CAUGHT ON THE PROXIMAL EDGE OF A JAILED BALLOON IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY. RESISTANCE MET WITH THE BALLOON DURING REMOVAL. THE DEVICE WAS REPLACED WITH A NON-ABBOTT 4.0MM STENT TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161131 ↗