XIENCE Skypoint™ 1804325-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648233319), received between Nov 10, 2021 and Mar 10, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 11/09/2022, THE PATIENT WITH A HISTORY OF ST ELEVATION MYOCARDIAL INFARCTION (STEMI) HAD 1 XIENCE SKYPOINT (3.25X15MM) STENT IMPLANTED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED WITH AN STEMI, CHEST PAIN AND IN STENT THROMBOSIS. THE PATIENT WAS NOT COMPLIANT WITH TICAGRELOR. A MEASURE OF CARDIAC SAMPLE WAS PERFORMED OF THE LEFT HEART THROUGH A PERCUTANEOUS APPROACH. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2022 NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 16525382 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT HAD A 3.25X15MM XIENCE SKYPOINT STENT IMPLANTED. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE CHEST PAIN, HYPERTENSIVE HEART/HEART FAILURE. THERE WAS NO TREATMENT REPORTED AND THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Heart Failure/Congestive Heart Failure

  MAUDE report 14149509 ↗
• MalfunctionFeb 1, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). THE 3.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE SDS WAS REMOVED AND RE-INSERTED. RESISTANCE WAS FELT WITH AN UNSPECIFIED GUIDE EXTENSION DURING ADVANCEMENT OF THE SDS AND THE STENT DISLODGED. THE ENTIRE SYSTEM WAS REMOVED AS ONE UNIT INCLUDING THE DISLODGED STENT. ANOTHER 3.0X12MM XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416418 ↗
• MalfunctionNov 10, 2021Loose or Intermittent Connection; Activation Failure; Noise, Audible; Loose or Intermittent Connection; Activation Failure; Noise, Audible

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THERE WAS NOTED DIFFICULTY (RESISTANCE) CONNECTING THE XIENCE SKYPOINT TO THE INDEFLATOR AND AN ABNORMAL NOISE WAS NOTED; HOWEVER, IT WAS ABLE TO BE ULTIMATELY CONNECTED. THE STENT DELIVERY SYSTEM WAS THEN ADVANCED TO THE LESION BUT COMPLETELY FAILED TO DEPLOY. THE DEVICE WAS REPLACED WITH ANOTHER 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 12790908 ↗