XIENCE Skypoint™ 1804500-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648233661), received between Feb 24, 2023 and May 3, 2023 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 5.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED WITHOUT ISSUE. AFTER DEPLOYMENT, THE SDS BALLOON ONLY PARTIALLY DEFLATED. DURING REMOVAL, RESISTANCE WAS MET; THEREFORE, THE SDS WAS REMOVED WITH THE GUIDE LINER AND GUIDEWIRE AS A UNIT. ANOTHER GUIDE LINER AND GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 16862066 ↗
• DeathFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN POOR CONDITION WITH AN EJECTION FRACTION OF 10% (NORMAL 50-65%), FRIABLE VESSELS, CHEST PAIN AND A HISTORY OF CORONARY HEART DISEASE. DURING THE PROCEDURE, THE 5.00X28MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE LESION IN THE SAPHENOUS VEIN GRAFT (SVG), AND DEPLOYED AT 12 ATMOSPHERES; AFTER WHICH, A LARGE PERFORATION WAS NOTED, DUE TO THE FRIABLE VESSEL. THREE NON-ABBOTT COVERED STENTS WERE IMPLANTED TO SUCCESSFULLY SEAL THE PERFORATION; HOWEVER, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND THE AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) DEFIBRILLATED THE PATIENT A COUPLE OF TIMES. ADDITIONALLY, THE PATIENT WAS DEFIBRILLATED MULTIPLE TIMES WITH AN EXTERNAL DEFIBRILLATOR, BUT COULD NOT BE RESUSCITATED AND DIED. IN THE PHYSICIAN'S OPINION, THE XIENCE STENT DID NOT CAUSE THE PERFORATION. THE PERFORATION WAS DUE TO THE PATIENT HAVING A FRIABLE VESSEL. THE XIENCE STENT HAD NO DEVICE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels; Ventricular Fibrillation

  MAUDE report 16436961 ↗