XIENCE Skypoint™ 1804275-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648233197), received between Jan 13, 2021 and Oct 18, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionOct 18, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. PRE-DILATATION WAS PERFORMED USING A 2.5X12MM NON-ABBOTT SEMI COMPLIANT BALLOON. THE 2.75X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AND WAS NOTED TO HAVE A FRACTURED AND LIFTED PROXIMAL EDGE OF THE STENT THAT REMAINED IN ONE PIECE. A 2.75X38MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15629370 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2022, TREATING A TARGET LESION IN THE MILDLY TORTUOUS LEFT CIRCUMFLEX (CX) ARTERY. A 2.75 X 33 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE DISTAL CX TO 2ND-3RD MARGINAL ARTERY. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED WITH EXERTIONAL CHEST PAIN. IN-STENT RESTENOSIS WAS NOTED IN THE CX ARTERY. TARGET LESION REVASCULARIZATION WAS PERFORMED, WITH INFLATION OF A DRUG COATED BALLOON AT THE IN-STENT RESTENOSIS IN THE DISTAL CX AND IMPLANT OF A DRUG ELUTING STENT IN THE CX ARTERY, OVERLAPPING THE 2.75 X 33 MM XIENCE SKYPOINT STENT. THE PATIENT WAS DISCHARGED TO HOME ON ANTICOAGULATION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 15255540 ↗
• MalfunctionFeb 22, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PACKAGING OF A 2.75X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS OPENED; HOWEVER, THE DEVICE IN THE PACKAGING WAS A 2.75X38MM XIENCE SKYPOINT INSTEAD OF A 2.75X33MM XIENCE SKYPOINT. A NEW 2.75X33MM XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL MDR, THE FOLLOWING INFORMATION WAS RECEIVED: THE DATE OF EVENT IS 01/28/2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13579407 ↗
• MalfunctionDec 7, 2021Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER UNPACKING, UNSPECIFIED FOREIGN MATERIAL WAS NOTED ON THE TIP OF A 2.75X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AN UNSPECIFIED XIENCE STENT WAS USED TO SUCCESS FULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS FOUND THAT THE FOREIGN MATERIAL IS A MANUFACTURING COMPONENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952606 ↗
• MalfunctionJul 16, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID TO DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75X3MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WITH THE ANATOMY WAS ALSO NOTED. A 2.75X33MM NON-ABBOTT STENT 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 12181210 ↗
• MalfunctionJan 13, 2021Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED:THE REPORTED BALLOON RUPTURE WAS ACTUALLY AN INNER MEMBER TEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11163956 ↗