XIENCE Skypoint™ 1804300-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648233227), received between May 5, 2021 and Jan 28, 2026 — classified as 1 death, 7 injuries, 9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), HAD TWO XIENCE SKYPOINT (3.0X12, 4.0X38 MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE AND THROMBUS ON A CARDIAC DEVICE. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS DISCHARGED TO HOSPICE ON (B)(6) 2025. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24201971 ↗
• MalfunctionOct 27, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 3.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COMPLETELY FAILED TO INFLATE AND COULD NOT BE DEPLOYED. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER SAME SIZE 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 23397518 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN OCTOBER 2022, ONCE 2.5X08MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL, 3.5X23MM, 3.5X12MM, 3.5X15MM XIENCE SKYPOINTS IMPLANTED IN PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). ANOTHER 3.0X23, 3.0X12MM AND 3.5X08MM XIENCE SKYPOINTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITHOUT ISSUE. HOWEVER, IN (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN AND DIZZINESS. THEREFORE, A STRESS TEST AND ANGIOGRAM REVEALED THE MID RCA AND MID LAD ARE OCCLUDED. PATIENT IS AWAITING BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Obstruction/Occlusion

  MAUDE report 23270332 ↗
• MalfunctionSep 4, 2025Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND AIR REMOVAL WAS ATTEMPTED PRIOR TO POSITIONING AT THE LESION. NEGATIVE PRESSURE COULD NOT BE PROPERLY APPLIED AND BLOOD RETURNED INTO THE SYSTEM. THE DEVICE WAS NOT USED AND WAS REPLACED WITH A NEW SAME SIZE XIENCE SKYPOINT SDS. 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 22964356 ↗
• MalfunctionDec 3, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THERE WAS RESISTANCE IN THE GUIDING CATHETER WHEN THE 4.0X8 MM BALLOON WAS ADVANCED. WHEN RESISTANCE WAS FELT DURING REMOVAL, FORCE WAS APPLIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20836894 ↗
• MalfunctionDec 8, 2023Inflation Problem; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation; Inflation Problem; Deformation Due to Compressive Stress; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFIED, MILDLY TORTUOUS AND 85% STENOSED. REPORTEDLY, WHEN IMPLANTING THE XIENCE SKYPOINT, THE STENT BALLOON WAS PARTIALLY INFLATED BUT WAS NOT IMPLANTED SUCCESSFULLY AS THE STENT SHAFT WAS BENT. THE DELIVERY SYSTEM, WITH THE STENT WERE REMOVED AND A NEW STENT WAS USED AND IMPLANTED. THE PROCEDURE WAS COMPLETED. 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 18293377 ↗
• InjuryOct 20, 2023Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS PROVIDED WHICH STATED THAT A CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED BUT THE PATIENT EXPIRED SINCE A DO-NOT-RESUSCITATE ORDER (DNR) WAS REQUESTED. THE PHYSICIAN STATED THE XIENCE SKYPOINT STENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17977512 ↗
• MalfunctionMay 4, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 90% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL, HOWEVER, THE DEVICE WAS REMOVED INDEPENDENTLY. 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 16872577 ↗
• InjuryMar 24, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON 1/31/2022, A 3.0X23MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. A SECOND 3.0X12MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL WITH NO ISSUES. DURING THE WINTER TIME THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN, SHORTNESS OF BREATH AND PAIN IN THE ARM. ON 2/28/2023, IT WAS CONFIRMED BOTH STENT'S HAD COLLAPSED AND A NEW UNSPECIFIED STENT WAS IMPLANTED FOLLOWED BY ADDITIONAL ANGIOPLASTY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dyspnea; Obstruction/Occlusion; Pain

  MAUDE report 16612500 ↗
• InjuryDec 6, 2022Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE 1ST OBTUSE MARGINAL ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. A 2.50X23MM XIENCE SKYPOINT STENT WAS IMPLANTED; HOWEVER, THE STENT WAS NOT LONG ENOUGH FOR THE LESION, SO A 3.00X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT MET RESISTANCE DUE TO THE TORTUOSITY OF THE VESSEL. THE DEVICE WAS RE-POSITIONED AND ATTEMPTED AGAIN TO ADVANCE TO THE LESION. A FALSE LUMEN MAY HAVE BEEN CREATED AND THE VESSEL APPEARED DAMAGED. THE 3.0 X 12 MM XIENCE SKYPOINT WAS REMOVED FROM THE PATIENT. UPON REMOVAL, THE DISTAL EDGE STENT STRUTS WERE NOTED TO BE FLARED AND THE PROXIMAL STENT WAS NOTED TO BE DEFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO FURTHER TREATMENT TO THE PATIENT WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15926322 ↗
• MalfunctionNov 29, 2022Difficult 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 LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.0X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED HOWEVER IT FAILED TO CROSS THE ANATOMY TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY 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 15882959 ↗
• InjuryOct 31, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO RESISTANCE WITH ANATOMY. HOWEVER, DURING REMOVAL THE SDS MET RESISTANCE WITH A PREVIOUSLY IMPLANTED STENT IN THE PROXIMAL RIGHT CORONARY ARTERY. THE STENT DISLODGED AND AN UNSPECIFIED BALLOON WAS USED TO FULLY EXPAND THE STENT IN PROXIMAL RIGHT CORONARY ARTERY. PHYSICIAN DID NOT ATTEMPT TO SNARE, DECISION WAS MADE TO IMPLANT STENT WHERE IT HAD DISLODGED IN THE PROXIMAL RCA AS IT WAS BELIEVED THAT THE PREVIOUSLY IMPLANTED STENT WAS FRACTURED PRIOR TO THE START OF THE PROCEDURE AND WAS INITIALLY ALSO GOING TO GET TREATED. NO OTHER DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15703912 ↗
• DeathJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, AFTER LESION PREPARATION WITH A CUTTING BALLOON, A 3.00 X 12 MM XIENCE SKYPOINT DRUG ELUTING STENT WAS SUCCESSFULLY IMPLANTED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY. ON (B)(6) 2022, THE PATIENT EXPERIENCED SUDDEN CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS INITIATED; HOWEVER, THE PATIENT AND FAMILY DID NOT WANT FURTHER TREATMENT, SO ALL LIFE SAVING TREATMENT WAS STOPPED AND THE PATIENT DIED. THE PHYSICIAN COMMENTED THAT IT IS DIFFICULT TO SAY IF THE XIENCE SKYPOINT CAUSED OR CONTRIBUTE TO THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 14945926 ↗
• InjuryMay 3, 2022Difficult 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 A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.75X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED WITHOUT ISSUE AT THE PROXIMAL LAD. A DECISION WAS MADE TO IMPLANT A SECOND 3.0X28MM XIENCE SKYPOINT (SDS) DISTAL TO THE FIRST PREVIOUSLY IMPLANTED STENT AS THE LESION WAS LONGER THAN EXPECTED. A THIRD 3.0X12MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO BE IMPLANTED DISTAL TO BOTH PREVIOUSLY IMPLANTED STENTS; HOWEVER, THE STENT COULD NOT CROSS BOTH STENTS. EXCESSIVE FORCE WAS APPLIED. THERE WAS RESISTANCE PULLING BACK DUE TO THE PREVIOUSLY IMPLANTED STENTS. WHEN THE STENT DEVICE WAS PULLED BACK, THE STENT DISLODGED OFF THE BALLOON. THE DISLODGED STENT REMAINED ON THE WIRE AND A NON-ABBOTT DEVICE WAS USED TO OPEN UP THE STENT. A LARGER BALLOON A 3.0 NC TREK WAS USED TO HELP DEPLOY THE STENT. THE STENT WAS DEPLOYED IN BOTH HEALTHY TISSUE AND IN THE TARGET LESION AT THE PROXIMAL END OF THE FIRST IMPLANTED STENT. NO FURTHER DEVICES WERE USED AS THE PROCEDURE WAS COMPLETE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270070 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED DE NOVO DISTAL RIGHT CORONARY ARTERY THAT WAS 100% STENOSED. A 3X12MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY, AND DURING REMOVAL RESISTANCE WAS ALSO MET WITH ANATOMY. 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 12955847 ↗
• MalfunctionSep 2, 2021Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.00X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) CROSSED THE LESION; HOWEVER, STRONG RESISTANCE WAS NOTED WITH THE ANATOMY AND THE DEVICE WAS REMOVED. AFTER REMOVAL FROM THE ANATOMY, THE STENT DISLODGED. AN UNSPECIFIED NON-ABBOTT DEVICE 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 12418111 ↗
• MalfunctionMay 5, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED CONCENTRIC LESION IN THE RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. SEVERAL ATTEMPTS WERE MADE TO CROSS, BUT WERE UNSUCCESSFUL. DURING REMOVAL OF THE SDS RESISTANCE WITH THE ANATOMY WAS FELT. AN UNSPECIFIED DRUG-COATED BALLOON CATHETER 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 11780786 ↗