XIENCE Skypoint™ 1804225-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648233012), received between Jun 14, 2021 and Jul 20, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2026Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25873308 ↗
• MalfunctionAug 25, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 2.25X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS ATTEMPTED TO BE ADVANCED INTO THE LESION; HOWEVER, FAILED TO CROSS. UPON REMOVING THE DES FROM THE ANATOMY, IT WAS OBSERVED THAT THE STENT HAD BECOME DISLODGED AND LOOSE FROM THE BALLOON. THEREFORE, THE DES WAS REPLACED WITH A NON-ABBOTT DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885620 ↗
• InjuryMay 16, 2025Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. AFTER AN INITIAL UNSPECIFIED STENT WAS IMPLANTED, THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCE TO THE TARGET LESION; HOWEVER, THE SDS FAILED TO ADVANCE TO THE MID RCA DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED WITH RESISTANCE DUE TO THE ANATOMY AND THEN THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. A NON-COMPLIANT BALLOON WAS USED TO IMPLANT THE STENT IN THE PROXIMAL RCA PARTIALLY IN THE INITIALLY IMPLANTED STENT. THIS ENDED THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038402 ↗
• InjuryMar 6, 2024Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST DIAGONAL BRANCH ARTERY LESION. A 2.25X23 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE PLACED VIA RADIAL APPROACH BUT WAS UNSUCCESSFUL. DURING REMOVAL THE SDS GOT CAUGHT ON A PREVIOUS IMPLANTED STENT AND THE STENT WAS STRIPPED OFF THE DELIVERY SYSTEM. THERE WAS AN ATTEMPT TO SNARE THE DEVICE OUT BUT WAS UNSUCCESSFUL. A SEMI COMPLAINT 1.5X15MM BALLOON WAS USED TO PULL THE STENT BACK TO THE PROXIMAL ARTERY AND THE STENT WAS CRUSHED AGAINST THE ARTERY WALL. A 3.0X23MM XIENCE SKYPOINT WAS THEN DEPLOYED ACROSS IT. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18846106 ↗
• MalfunctionNov 28, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS. THE 2.25 X 23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. THERE WAS ALSO RESISTANCE FELT WITH THE ANATOMY DURING REMOVAL OF THE SDS. THE SDS WAS ABLE TO BE REMOVED INDEPENDENTLY. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223101 ↗
• MalfunctionAug 25, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. AFTER PRE-DILATATION, THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE ANATOMY AND RESISTANCE WAS ALSO NOTED DUE TO THE ANATOMY. A NON-ABBOTT 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 17628462 ↗
• InjuryJun 28, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). THE 2.25X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE ANATOMY. THERE WAS A POSSIBLE DISSECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 17221227 ↗
• MalfunctionFeb 27, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.25X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. UPON REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 16446255 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO CROSS THE LESION; HOWEVER, FAILED DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 14978869 ↗
• MalfunctionMay 24, 2022Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SECOND DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANATOMY AND THE STENT STRUT BECAME FLARED. ONCE REMOVED, IT WAS NOTED THAT THE DISTAL EDGE STENT STRUT WAS BROKEN [FRACTURE]. ANOTHER 2.25X23MM XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488757 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS ADMITTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THREE XIENCE SKYPOINT STENTS (2.25X23MM, 2.5X18MM, 2.75X23MM) WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND STEMI. PERCUTANEOUS CORONARY ANGIOPLASTY WAS PERFORMED IN TWO PLACES, RESOLVING THE EVENT AND THE PATIENT WAS DISCHARGED HOME WITH NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 14190851 ↗
• MalfunctionApr 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT POSTERIOR DESCENDING CORONARY ARTERY (RPDA). THE 2.25 X 23 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 14168142 ↗
• MalfunctionApr 7, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION, THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED AFTER REMOVING THE PROTECTIVE SHEATH/STYLET REMOVAL, HOWEVER, THE STENT WAS REMOVED FROM THE SUPPORT STYLET [PROTECTIVE SHEATH] WITH A LITTLE UNUSUAL RESISTANCE NOTED. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT 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 14045300 ↗
• MalfunctionMar 24, 2022Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED AT THE TARGET LESION WITHOUT ISSUE. DURING REMOVAL OF THE DEVICE FROM THE ANATOMY, THE BALLOON DID NOT RE-WRAP AS EXPECTED AND WAS DIFFICULT TO PULL BACK INTO THE GUIDING CATHETER, IN ORDER TO REMOVE THE DELIVERY SYSTEM FROM THE ANATOMY; HOWEVER, IT WAS REMOVED SUCCESSFULLY APPLYING A LITTLE FORCE. 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 13879860 ↗
• MalfunctionMar 3, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A GREATER THAN 80% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH THE GUIDING CATHETER HOWEVER, IT WOULD NOT ADVANCE EVEN WHEN FORCE WAS APPLIED AND THERE WAS RESISTANCE DURING REMOVAL. THE SDS AND THE GUIDING CATHETER WERE RETRIEVED TOGETHER AS ONE UNIT. IT WAS NOT UNTIL THE DEVICE WAS ON THE TABLE AND THE STENT WAS PULLED FROM THE GUIDING CATHETER THAT THE SHAFT WAS NOTED TO BE KINKED. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. 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 13661595 ↗
• MalfunctionJan 19, 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 HEAVY TORTUOUS LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 2.25 X 23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THEN RESISTANCE WAS FELT UPON REMOVAL OF THE SDS DUE TO ANATOMICAL CHALLENGES AND THE STENT EDGE WAS OBSERVED TO BE FLARED. THE TARGET LESION WAS TREATED WITH AN UNSPECIFIED XIENCE SKYPOINT. THERE WAS 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 13290219 ↗
• MalfunctionDec 18, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND THE STENT MOVED ON THE BALLOON. THE SDS WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 13040118 ↗
• InjuryDec 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A CORONARY INTERVENTION. THE LESION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS) AND THE 2.25X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED AT 12 ATMOSPHERES IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS MORE THAN 20MM, ECCENTRIC, MILD TORTUOSITY, MILD CALCIFICATION, NO-ENTRANCE LOCATION, NO BRANCHES, NO THROMBOSIS, NON CHRONIC TOTALLY OCCLUDED (CTO) LESION. A BALLOON WAS USED FOR POST DILATATION PER STANDARD PRACTICE. THE NEXT DAY, ON (B)(6) 2021, THE PATIENT WAS STILL IN THE HOSPITAL AND THEY EXPERIENCED A MYOCARDIAL INFARCTION IN THE LAD. HEMATOMA WAS ALSO FOUND 5 MM DISTAL TO THE DISTAL PART OF THE STENT. IMPAIRED FLOW OF BLOOD WAS NOTED ON THE MAIN TRUNK. THERE WAS NO REMARK OF STENT THROMBOSIS AND BLOOD CIRCULATION DID NOT IMPROVE. AT OCCURRENCE OF THE EVENT, THREE ANTI-PLATELETS (PRASUGREL, ASPIRIN, AND DOAC) WERE PRESCRIBED (ONE FOR EACH). THERE WAS NO OTHER TREATMENT PERFORMED. IT IS UNKNOWN IF THE HOSPITALIZATION WAS INCREASED DUE TO THE ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hematoma; Myocardial Infarction

  MAUDE report 13040113 ↗
• MalfunctionDec 8, 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 POSTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 2.25X23MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY, AND RESISTANCE WITH ANATOMY WAS ALSO MET DURING REMOVAL. A 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 12960714 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT POSTERIOR ATRIO-VENTRICULAR ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS DUE TO RESISTANCE WITH THE LESION. THE STENT GOT CAUGHT IN THE CALCIFIED LESION AND BECAME FLARED. THERE WAS ALSO RESISTANCE WITH THE LESION DURING REMOVAL. A SAME SIZE XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. 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 12235266 ↗
• MalfunctionJun 14, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY WITH 80% STENOSIS. THE 2.25X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED. UPON INFLATION IT WAS NOTED THAT THE BALLOON OF THE SDS HAD RUPTURED; HOWEVER, THE STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED AT THE INTENDED SITE. 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 11996552 ↗