XIENCE Skypoint™ 1804250-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648233067), received between Feb 1, 2021 and Feb 20, 2025 — classified as 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL CORONARY ARTERIES. A 2.5X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IN THE DIAGONAL ARTERY PRIOR TO DEPLOYMENT AND THEY WERE TRYING TO KEEP THE PLAQUE FROM SHIFTING FROM THE DIAGONAL TO THE LAD. THE 3.0X15 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) COULD NOT ADVANCE AND GOT SNAGGED ON THE UNDEPLOYED STENT IN THE DIAGONAL AND SEPARATED AT THE DISTAL SHAFT. EVERYTHING WAS ABLE TO BE REMOVED ON THE GUIDE WIRE DESPITE DIFFICULTY AND SOME FORCE WAS USED. THE PROCEDURE WAS COMPLETED WITH A NEW STENT AND BALLOON. 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 21425649 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.5X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS IMPLANTED IN THE MID CIRCUMFLEX, FOLLOWED BY A 2.5X12MM XIENCE SKYPOINT IN THE OSTIAL CIRCUMFLEX AND CONCLUDING WITH A 2.75X28 XIENCE SKYPOINT IN THE LEFT MAIN. ALL THREE XIENCE SKYPOINT'S WERE IMPLANTED SUCCESSFULLY WITHOUT ISSUE. POST PROCEDURE THE PATIENT BECAME UNRESPONSIVE AND PULSELESS VENTRICULAR FIBRILLATION WAS NOTED. ANGIOGRAM CONFIRMED THROMBOSIS IN ALL THREE IMPLANTED STENTS. THE PATIENT WAS BROUGHT BACK INTO THE CATH LAB AND CPR WAS PERFORMED BUT THE PATIENT EXPIRED. A CLINICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 20619844 ↗
• MalfunctionJul 15, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TO MODERATE CALCIFICATION. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET WITH RESISTANCE DURING ADVANCEMENT DUE TO THE ANATOMY AND THE PROXIMAL SHAFT BROKE IN 2 PIECES. HOWEVER, THE BREAK OCCURRED OUTSIDE THE ANATOMY; THEREFORE, THE SDS WAS SIMPLY REMOVED. ANOTHER 2.5X12MM XIENCE SKYPOINT STENT WAS USED TO COMPLETE 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 19741823 ↗
• MalfunctionJun 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MODERATELY STENOSED LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY. THE 2.50X12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER DURING THE FIRST INFLATION TO 6 ATMOSPHERES, THE BALLOON RUPTURED. THE SDS WITH THE STENT WAS REMOVED WITHOUT ISSUE. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556425 ↗
• InjuryNov 10, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE AN ATTEMPT WAS MADE TO DIRECT STENT A HEAVILY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE LESION, BUT RESISTANCE WAS MET AND THE SDS WAS PUSHED TOO HARD, RESULTING IN THE STENT DISLODGING FROM THE BALLOON. A 3.5 NON-ABBOTT STENT WAS DEPLOYED AND USED TO EMBED THE DISLODGED STENT IN THE PROXIMAL CIRCUMFLEX. THERE WAS NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18112121 ↗
• MalfunctionOct 9, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN CIRCUMFLEX (CX) ARTERY. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED; HOWEVER THE SDS WAS NOTED TO BE EXPIRED. THE WAS NO ISSUE WITH THE IMPLANTATION OF THE STENT. 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 17900516 ↗
• MalfunctionOct 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY. POST STENT IMPLANTATION OF A NON-ABBOTT STENT A DISSECTION WAS NOTED. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO TREAT THE DISSECTION; HOWEVER, WHEN PRESSURE WAS APPLIED TO THE INDEFLATOR, PRESSURE DID NOT INCREASE AND CONTRAST WAS OBSERVED LEAKING FROM THE SDS BALLOON. THE PRESSURE WAS ABLE TO BE RAISED TO 9 ATMOSPHERES AND THE STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED PER STANDARD 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 17881824 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED OSTIAL RIGHT CORONARY ARTERY. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE SDS WAS REMOVED TO ADD A GUIDELINER. WHEN THE SDS WAS REMOVED THE STENT WAS NOTED TO BE DISLODGED AND UNDER FLUOROSCOPY WAS NOTED TO BE IN THE GUIDING CATHETER. THE STENT THEN TRAVELED TO THE DESCENDING AORTA. THE DISLODGED STENT WAS ABLE TO BE RETRIEVED VIA SNARE. ANOTHER XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725823 ↗
• MalfunctionFeb 20, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS, 75% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) ARTERY. A 2.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE ANATOMY. RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NON-ABBOTT DEVICE OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406171 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND ON (B)(6) 2022 A 2.5X12 MM AND A 3.0X38 MM XIENCE SKYPOINT STENT WERE IMPLANTED. ON (B)(6) 2022 THE PATIENT WAS RE ADMITTED TO THE HOSPITAL DUE TO TIETZE SYNDROME [CHEST PAIN] AND ACUTE MYOCARDIAL INFARCTION. SURGERY AND CARDIAC "SANPL" WERE PERFORMED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 15043417 ↗
• InjuryJun 22, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS RIGHT CORONARY ARTERY. THREE XIENCE SKYPOINT STENT DELIVERY SYSTEMS (2.5X15MM, 2.5X12MM, AND 2.5X08MM) FAILED TO CROSS THE LESION; HOWEVER, A DISSECTION WAS NOTED. IT IS UNKNOWN IF THERE WAS ANY TREATMENT PROVIDED FOR THE DISSECTION. AN UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14776159 ↗
• InjuryJun 7, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LESION IN THE MID RAMUS. A 2.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS BEING ADVANCED TO THE TARGET LESION WHEN A DISSECTION OCCURRED. THE DES WAS NOT IMPLANTED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE AN UNKNOWN TREATMENT WAS PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14621821 ↗
• MalfunctionJun 1, 2022Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE WITH AN UNSPECIFIED GUIDE CATHETER. THE DISTAL EDGE OF THE STENT BECAME FLARED. RESISTANCE DURING REMOVAL WITH THE GUIDING CATHETER WAS NOTED. ANOTHER UNSPECIFIED DEVICE 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 14565890 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 TWO XIENCE SKYPOINT DRUG ELUTING STENTS (DES) WERE IMPLANTED, A 2.5X12MM AND A 3X18MM, WITHOUT ISSUE. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH CORONARY ARTERY DISSECTION, AND MYOCARDIAL INFARCTION. MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Vascular Dissection

  MAUDE report 14045518 ↗
• MalfunctionMar 31, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. A 2.50X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED HOWEVER, IT FAILED TO CROSS. THE XIENCE SKYPOINT WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS INSERTED AGAIN, BUT AGAIN FAILED TO CROSS THE LESION. DURING REMOVAL, THE DISTAL STENT EDGE WAS NOTED TO BE FLARED AND RESISTANCE WAS NOTED WITH THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE DEVICE WAS REPLACED WITH A XIENCE SKYPOINT 2.25X12MM TO CONTINUE, FOLLOWED BY STENT DEPLOYMENT. AFTER POST DILATATION WAS PERFORMED, THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13958082 ↗
• MalfunctionMar 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 2.5X12MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY AND IT WAS NOTED RESISTANCE WAS FELT WITH ANATOMY DURING REMOVAL OF THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13750626 ↗
• MalfunctionMar 9, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED UNSPECIFIED LESION. THE HT BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE BECAME STUCK WITH THE 2.5X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DURING ADVANCEMENT. THE GUIDE WIRE AND THE SDS WERE REMOVED AS ONE UNIT. ANOTHER XIENCE SKYPOINT AND BMW ELITE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13711287 ↗
• MalfunctionDec 6, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. A 2.5X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND THE DES COULD NOT REACH THE TARGET LESION TO BE TREATED. THE DES WAS REMOVED WITH RESISTANCE AND A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933704 ↗
• MalfunctionFeb 1, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) THAT IS 90% STENOSED. TWO DIFFERENT SIZE XIENCE SKYPOINT STENT DELIVERY SYSTEMS (2.5X15MM AND 2.5X12MM) WERE ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO ANATOMY. IT WAS NOTED THERE WAS RESISTANCE DURING REMOVAL WITH ANATOMY. A THIRD NON-ABBOTT STENT WAS ATTEMPTED TO ADVANCE, BUT FAILED. THE PROCEDURE WAS ABANDONED WITHOUT FURTHER TREATMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258791 ↗