XIENCE Skypoint™ 1804225-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648233005), received between Aug 9, 2021 and Mar 12, 2026 — classified as 2 deaths, 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Difficult to Remove; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE SAPHENOUS VEIN GRAFT (SVG) TO DIAGONAL CORONARY ARTERY ANASTOMOSIS WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. THE LESION WAS PRE-DILATED WITH AN NC BALLOON AND A GUIDE EXTENSION CATHETER WAS USED TO DELIVER THE 2.25X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS). THE STENT WAS DEPLOYED AND UPON REMOVAL OF THE DELIVERY SYSTEM BALLOON. THE STENT WAS PULLED BACK FROM THE LESION SITE INTO THE SVG WHERE IT REMAINS AND IT IS PARTIALLY INSIDE THE TARGET LESION. THE STENT WAS POST-DILATED AND APPEARS TO MATCH THE VESSEL SIZE. THE PATIENT REMAINED STABLE AND PAIN FREE THROUGHOUT THE PROCEDURE AND THEY WERE MONITORED OVERNIGHT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580203 ↗
• MalfunctionJun 18, 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 90% STENOSED, HEAVILY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25X18MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS ATTEMPTED TO BE ADVANCED INTO THE LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. SUBSEQUENTLY FOLLOWING THE WITHDRAWAL OF THE DES THE STENT WAS NOTED TO HAVE MOVED BUT REMAINED TIGHTLY CRIMPED ON THE BALLOON. THEREFORE A NEW 2.25X28MM XIENCE DES WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22288280 ↗
• MalfunctionJun 16, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) ARTERY WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS INITIALLY FAILED TO CROSS DUE THE ANATOMY. ADDITIONAL PRE-DILATATION WAS PERFORMED AND THE SDS WAS ABLE TO BE SUCCESSFULLY ADVANCED TO THE TARGET LESION. THE DELIVERY SYSTEM BALLOON OF THE SDS WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. A NON-ABBOTT STENT WAS USED TO CONTINUE 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 22212673 ↗
• DeathJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). ON (B)(6) 2024 PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT LESIONS IN THE LEFT MAIN TRUNK (LMT) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. PRIOR TO STENT IMPLANTATION, THE LESIONS WERE TREATED WITH INTRAVASCULAR LITHOTRIPSY (IVL) AND PRE-DILATED WITH A NON-COMPLIANT BALLOON. THEN, A 2.25X18MM, 3X33MM AND 3.5X28MM XIENCE SKYPOINT STENTS WERE IMPLANTED FOLLOWED BY POST DILATATION. AT SOME POINT DURING THE PROCEDURE A CORONARY ARTERY DISSECTION OCCURRED; HOWEVER WAS COVERED WITH STENTS. THEN, ON (B)(6) 2024 THE PATIENT EXPERIENCED DIFFICULTY WALKING AND WAS HOSPITALIZED. AN MRI REVEALED ISCHEMIC STROKE. ON (B)(6) 2024 THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, WHERE ON (B)(6) 2024 AN ABLATION PROCEDURE WAS PERFORMED DURING WHICH REPORTED BLEEDING OCCURRED IN THE RIGHT FEMORAL PUNCTURE SITE. THE PATIENT WAS DISCHARGED A FEW DAYS LATER. DURING THE 1 YEAR FOLLOW-UP CALL IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT DIED DURING HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA; Vascular Dissection

  MAUDE report 22170979 ↗
• InjuryApr 25, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MILDY CALCIFIED, MILDLY TORTUOS LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING ADVANCEMENT OF A 2.25X18MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES), RESISTANCE WAS MET WITH A PREVIOUSLY IMPLANTED UNSPECIFIED XIENCE SKYPOINT DES AND THE 2.25X18MM XIENCE SKYPOINT STENT DISLODGED IN THE LEFT MAIN CORONARY ARTERY AND WAS RETRIEVED VIA SNARE. AN UNSPECIFIED XIENCE DES WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911210 ↗
• MalfunctionFeb 7, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, FURTHER REVIEW OF THE REPORTED INFORMATION FOUND THAT RESISTANCE DURING REMOVAL WAS WITH THE ANATOMY. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660576 ↗
• MalfunctionDec 27, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE RX XIENCE SKYPOINT 2.25 X 18 MM STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE LESION. THE PATIENT EXPERIENCED NO UNTOWARD EFFECTS AS A RESULT OF THE FAILURE TO CROSS 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 18401433 ↗
• InjuryJul 24, 2023Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE CIRCUMFLEX (CX) CORONARY ARTERY. THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED AT 9 ATMOSPHERES AND THE STENT REACHED THE INTENDED SIZE DESPITE THE BALLOON LOSING PRESSURE. A NON-COMPLIANT (NC) BALLOON WAS USED FOR POST-DILATATION. AFTER REMOVAL, THE BALLOON WAS TESTED AND A LEAK WAS NOTED. ANOTHER NON-ABBOTT 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 17378948 ↗
• InjuryAug 3, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE INVOLVED THE USE OF A 6 FR SHEATH IN A RADIAL APPROACH TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS THE LESION. THERE WAS RESISTANCE WITH THE ANATOMY UPON REMOVAL. A 5.5 FR GUIDELINER WAS USED TO AID WITH ADVANCEMENT OF THE SDS, HOWEVER, THERE WAS STILL RESISTANCE WITH THE ANATOMY WHEN THE SDS WAS RE-ADVANCED. THE STENT DISLODGED BEFORE REACHING THE TARGET LESION AND REMAINED ON THE WIRE. A 1.5MM BALLOON WAS USED TO EXPAND AND IMPLANT THE STENT WHERE IT WAS WHICH WAS OUTSIDE THE TARGET LESION. THE PROCEDURE ENDED AT THIS POINT AND THE TARGET LESION WAS NOT TREATED. THE PROCEDURE WILL BE COMPLETED IN ABOUT 4-6 MONTHS WHEN THE PATIENT HAS HEALED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15161122 ↗
• InjuryJul 25, 2022Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, HOWEVER, FAILED TO CROSS THE LESION. THERE WAS NO RESISTANCE DURING REMOVAL OF THE SDS. ONCE REMOVED FROM THE PATIENT, IT WAS NOTED THE PROXIMAL END OF THE STENT LOOKED LIKE IT WAS LIFTED OFF THE BALLOON. ANOTHER XIENCE SKYPOINT OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. A DISSECTION WAS NOTED POST DEPLOYMENT/POST DILATATION BUT WAS NOT VISIBLE FOLLOWING REMOVAL OF THE DEVICE. THE DISSECTION WAS THOUGHT TO HAVE OCCURRED WHEN THE FIRST XIENCE SKYPOINT WAS ADVANCED AND FAILED TO CROSS BUT WAS NOT NOTICED UNTIL AFTER USE OF THE SECOND XIENCE SKYPOINT. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 15093734 ↗
• MalfunctionJul 8, 2022Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. A 2.75X18MM XIENCE STENT WAS IMPLANTED MID LAD, FOLLOWED BY A 3.00X28MM XIENCE STENT IMPLANTED PROXIMAL MID LAD AND THEN A 3.00X12MM XIENCE STENT WAS DEPLOYED TO OVERLAP THE 2 IMPLANTED STENTS. THE 2.50X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCE TO THE TARGET LESION; HOWEVER THE SDS GOT STUCK AND COULD NOT ADVANCE OR BE REMOVED FROM THE IMPLANTED 3.00X28MM XIENCE STENT; THEREFORE, THE STENT WAS DEPLOYED AT THE PROXIMAL/MID LAD, WHICH WAS NOT THE INTENDED LOCATION. ADDITIONALLY, THE SDS CATHETER BECAME KINKED. AFTER THE STENT WAS DEPLOYED, THE SDS WAS REMOVED FROM THE PATIENT. AT AN UNKNOWN POINT DURING THE PROCEDURE A 2.25X18MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO BE ADVANCED IN THE GUIDE CATHETER, BUT THE SHAFT BROKE WHILE ADVANCING THROUGH THE GUIDE CATHETER. THE 2.25X18MM XIENCE SKYPOINT SDS WAS SIMPLY REMOVED FROM THE PATIENT, WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF 2 NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14964403 ↗
• MalfunctionJun 1, 2022Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A MODERATELY CALCIFIED, MID LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, THE XIENCE SKYPOINT STENT SYSTEM DID NOT CROSS THE LESION AND THE SHAFT KINKED. RESISTANCE WAS NOTED DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SAME SIZE XIENCE SKYPOINT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569862 ↗
• DeathApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT POSTERIOR ATRIO-VENTRICULAR AND RIGHT POSTERIOR DESCENDING LESIONS ON 5/20/2021. PRE-DILATATION WAS PERFORMED WITH SEMI-COMPLIANT BALLOON. A 2.25X18MM XIENCE SKYPOINT WAS DEPLOYED AT 10 ATMOSPHERES WITHOUT POST DILATATION. THEN A 2.25X12MM XIENCE SKYPOINT WAS DEPLOYED AT 16 ATMOSPHERES WITH POST DILIATATION. NO ISSUE WAS NOTED DURING THE PROCEDURE. ON (B)(6) 2021 AND (B)(6) 2022, THE PATIENT CAME TO THE HOSPITAL BUT NO ISSUE WAS NOTED ON THE PATIENT'S CONDITION DURING THOSE VISITS. ON (B)(6) 2022, THE PATIENT DIED. RELATION BETWEEN THE INCIDENT AND THE STUDY IS NOT DETERMINED. PER THE PHYSICIANS CLINICAL DECISION THE CAUSE OF DEATH WAS DUE TO ACUTE MYOCARDIAL INFARCTION. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ANGIOGRAPHY WAS PERFORMED. PRESCRIBED ANTI-PLATELET DRUGS (CLOPIDOGREL, ASPIRIN) WERE STOPPED BEING APPLIED BY THE TIME THE PATIENT WAS RELEASED FROM HOSPITAL AFTER PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. NO ADDITIONAL INFORMATION.

  Patient problems: Myocardial Infarction

  MAUDE report 14160929 ↗
• MalfunctionMar 22, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE POSTERIOR DESCENDING ARTERY THAT WAS HEAVILY CALCIFIED, HEAVILY TORTUOUS, AND 90% STENOSED. A 2.25X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. DURING REMOVAL, DIFFICULTY WAS MET WITH THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13848141 ↗
• MalfunctionDec 13, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY (LCX) THAT IS 90% STENOSED. THE 2.25X18MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. IT WAS NOTED RESISTANCE WAS MET DURING REMOVAL WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988284 ↗
• InjuryNov 29, 2021Improper or Incorrect Procedure or Method; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE RIGHT CORONARY ARTERY (RCA). THE PROXIMAL RCA HAD AN UNSPECIFIED STENT IMPLANTED WITHOUT ISSUES. THE 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO TREAT THE DISTAL RCA, HOWEVER, THE STENT GOT CAUGHT WITH THE PREVIOUSLY IMPLANTED UNSPECIFIED STENT DAMAGING IT AND FAILED TO CROSS THE LESION. THE XIENCE SKYPOINT STENT THEN DISLODGED FROM THE BALLOON AND REMAINED EMBEDDED IN THE ARTERY. THE PROCEDURE WAS DISCONTINUED. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WERE NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12883495 ↗
• MalfunctionAug 9, 2021Difficult to Insert; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Insert; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 99% STENOSED, MODERATELY TORTUOUS, AND MILDLY CALCIFIED DE NOVO LESION IN THE DISTAL CIRCUMFLEX ARTERY. FOLLOWING PRE-DILATATION AND INTRAVASCULAR ULTRASOUND, A 2.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THE SDS WAS REMOVED AND RESISTANCE WAS FELT WITH THE EXTENSION CATHETER. AN ATTEMPT TO RE-ADVANCE THE SDS TOGETHER WITH AN EXTENSION CATHETER WAS PLANNED, BUT IT WAS NOTED THAT THE DISTAL TIP WAS COLLAPSED AND IT DID NOT ENTER THE EXTENSION CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 2.25X15MM XIENCE SKYPOINT STENT AND A 2.5X23MM XIENCE SKYPOINT STENT. 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 12294555 ↗