XIENCE Skypoint™ 1804300-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648233210), received between Jan 4, 2022 and Feb 25, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  SUBSEQUENT TO THE INITIAL FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2022. THE DATE THE PATIENT RETURNED TO THE HOSPITAL WITH SUDDEN ONSET ANGINA IS (B)(6) 2022. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AS TREATMENT. THE DRAGONFLY DEVICE WAS AN OPTIS AND NOT AN OPSTAR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 21462611 ↗
• MalfunctionApr 2, 2024Stretched; Device Dislodged or Dislocated; Material Deformation; Stretched; Device Dislodged or Dislocated; Material Deformation

  USER FACILITY MEDWATCH REPORT [MW5152005] RECEIVED THAT STATES: CATHETER DEFECTIVE AT JUNCTION OF RX. IT WAS REPORTED PRIOR TO THE PROCEDURE, THE 3.0X08MM XIENCE SKYPOINT STENT WAS NOTED TO BE DEFECTIVE AND STARTED TO UNRAVEL. THE DEVICE WAS NOT USED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19026965 ↗
• InjurySep 1, 2023Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure; Material Rupture; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX CORONARY ARTERY WITH NO CALCIFICATION AND NO TORTUOSITY. THE 3.0X08 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND THEN PREPPED, AND THEN INFLATION WAS ATTEMPTED. THE BALLOON WAS ABLE TO GET TO 16 ATMOSPHERES AFTER ONE INFLATION; HOWEVER, THE DEVICE WAS NOT HOLDING PRESSURE AND A RUPTURE WAS NOTED. THE STENT WAS 90% DEPLOYED. A NON-COMPLIANT (NC) BALLOON WAS USED FOR POST-DILATATION TO COMPLETE DEPLOYMENT OF THE STENT. THERE WERE NO ADVERSE PATIENT EFFECTS 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 17671692 ↗
• InjuryDec 22, 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 EXPERIENCED A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND 2 XIENCE SKYPOINT STENTS (3.0X08MM, 2.5X15MM) WERE IMPLANTED. ON (B)(6) 2022, THE PATIENT EXPERIENCED POST-PROCEDURAL CARDIAC DISTURBANCES AND AN ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS HOSPITALIZED. THROMBUS MAY HAVE BEEN NOTED IN ONE OF THE STENTS, SO PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. ON (B)(6) 2022, THE PATIENT EXPERIENCED A NON-ST ELEVATION MYOCARDIAL INFARCTION. STENOSIS WAS NOTED IN AN UNSPECIFIED STENT, UNRELATED TO THE XIENCE SKYPOINT STENTS AND A NON-ABBOTT STENT WAS IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 16038023 ↗
• MalfunctionNov 17, 2022Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY (RCA). THE 3.0X08MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS; HOWEVER, THE CAUSE IS UNKNOWN. RESISTANCE WAS NOTED DURING REMOVAL AND THE STENT BECAME BENT AS THE PROXIMAL EDGE BECAME CAUGHT ON SOMETHING. ANOTHER UNSPECIFIED XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811719 ↗
• InjuryJul 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 3X8MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED THROUGH A XIENCE STENT THAT WAS IMPLANTED 2 DAYS EARLIER. WHEN PULLING BACK TO POSITION THE STENT AT THE TARGET LESION, THE 3X8MM XIENCE SKYPOINT STENT INTERACTED WITH THE PREVIOUSLY IMPLANTED STENT AND DISLODGED FROM THE BALLOON, DISTAL TO THE IMPLANTED STENT. A SNARE WAS USED, AND THE DISLODGED STENT WAS SUCCESSFULLY REMOVED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. THE LESION WAS BALLOONED WITH AN UNSPECIFIED BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136368 ↗
• MalfunctionJul 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND MODERATE CALCIFICATION. THE 3.0X8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE LESION DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. THE SDS WAS REMOVED INDEPENDENTLY. THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION OR STENT DISLODGEMENT. A NON-ABBOTT STENT 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 14991154 ↗
• MalfunctionJun 29, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 3.0X8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THERE WAS NO DEVICE INTERACTION AND THERE WERE NO OTHER DEVICE ISSUES SUCH AS SHAFT SEPARATION OR STENT DISLODGEMENT. THE SDS WAS REMOVED INDEPENDENTLY; HOWEVER, THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. 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 14855904 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance; Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 3.8X08MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANATOMY AS WELL AS DURING REMOVAL OF THE SDS. IN THE PHYSICIAN'S OPINION THE NO CROSS WAS ALSO DUE TO THE STENT NOT BEING AS FLEXIBLE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14793410 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 99% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX (CX) CORONARY ARTERY. THE 3.0 X 8 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION BUT COULD NOT CROSS THE LESION AND DURING REMOVAL OF THE SDS THERE WAS RESISTANCE WITH THE LESION. A NEW NON-ABBOTT SDS 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 13154372 ↗