XIENCE Skypoint™ 1804275-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648233180), received between Oct 14, 2021 and Dec 5, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER PRE-DILATATION, THE 2.75X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED. THE DELIVERY SYSTEM BALLOON WAS USED FOR POST DILATION, WHEN DURING THE SECOND INFLATION AT 16 ATMOSPHERES (ATM) THE DELIVERY SYSTEM BALLOON RUPTURED. THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON 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 23724193 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.75X28MM XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2024. PATIENT BEGAN TAKING 3 CARDIOLOGIST-PRESCRIBED DRUGS: (1) BRILINTA ON (B)(6) 2024 - 2 90MG TABLETS DAILY; (2) EZETIMIBE ON (B)(6) 2024 - 1 10MG TABLET DAILY; AND (3) METOPROLOL ER SUCCINATE 25 MG TABLETS ON (B)(6) 2024 - 1 25MG TABLET DAILY. ON (B)(6) 2024, THE PATIENT DEVELOPED A RASH ON THE ARMS AND LEGS AND INTENSE ITCHING BEGAN. WITH PHYSICIAN'S GUIDANCE, PATIENT TRIED ELIMINATING CERTAIN DRUGS, RECEIVED STEROID TREATMENTS, BOTH INJECTIONS AND PREDNISONE PILLS. THE RASHES ARE STILL PERSISTING AND INTENSE ITCHING ON BOTH ARMS AND BOTH LEGS. IN THE PHYSICIAN'S OPINION, ONE OF THE THREE NEW DRUGS IS LIKELY CAUSING OR CONTRIBUTING TO THE RASH AND ITCHINESS. THE PATIENT IS NOT AWARE OF HAVING ANY ALLERGIES TO MEDICATIONS OR METALS AND HAS AN APPOINTMENT WITH THE ALLERGIST ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 19096635 ↗
• MalfunctionDec 21, 2023Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER PRE-DILATATION, THE 2.75X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS ATTEMPTED TO BE IMPLANTED; HOWEVER, THE BALLOON OF THE SDS RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED FROM THE PATIENT, AND ADDITIONAL PRE-DILATATION WAS PERFORMED. A 2.5X28MM XIENCE SKYPOINT STENT WAS SUCCESSFULLY DEPLOYED AND POST-DILATED 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 18374823 ↗
• MalfunctionJul 12, 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 LEFT CIRCUMFLEX (LCX) ARTERY. THE 2.75X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION FOR DIRECT STENTING, HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WAS ALSO NOTED DURING REMOVAL OF THE SDS DUE TO THE ANATOMY. AN ATTEMPT WAS THEN MADE TO CROSS WITH AN UNSPECIFIED BALLOON, BUT IT ALSO FAILED TO CROSS; THEREFORE THE PROCEDURE ENDED WITH NO TREATMENT PERFORMED. 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 17307890 ↗
• InjuryMay 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  SUBSEQUENT TO REPORTS BEING FILED, IT WAS REPORTED THAT THE PATIENT DIED OF HEART FAILURE ON (B)(6) 2024; HOWEVER, IN THE PHYSICIANS OPINION, THE XIENCE SKYPOINT STENT DID NO CAUSE OR CONTRIBUTE TO THE DEATH OR HEART FAILURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Enzyme Elevation; Diaphoresis; Myocardial Infarction; Nausea; Thrombosis/Thrombus

  MAUDE report 16899462 ↗
• MalfunctionMar 9, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). A 2.75X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16514028 ↗
• InjuryOct 7, 2022Device Damaged by Another Device; Device Damaged by Another Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15566697 ↗
• MalfunctionSep 19, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DISTAL RIGHT CORONARY ARTERY. AFTER PRE-DILATATION TO THE TARGET LESION, THE XIENCE SKYPOINT WAS ADVANCED, BUT THE STENT STRUT WAS GOT CAUGHT ON THE CALCIFICATION. THEREFORE, THE STENT SLID (DISLODGED) ON THE DELIVERY CATHETER BUT REMAINED ON THE DELIVERY SYSTEM. ANOTHER XIENCE 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 15451820 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB. TWO LESIONS WERE NOTED. ONE IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX) AND ONE IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.75 X 28MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED TO THE NON-CALCIFIED, MILDLY TORTUOUS 100% OCCLUDED LESION IN THE PLCX AND IMPLANTED, THEN A 2.5X18MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE DRCA.. POST ANGIOGRAPHY PICTURES LOOKED ACCEPTABLE; HOWEVER, BEFORE THE PATIENT WAS TAKEN OFF OF THE TABLE, THE PATIENT EXPERIENCED A LOT OF PAIN. ADDITIONAL ANGIOGRAPHY WAS PERFORMED AND THE 2.75 X 28MM XIENCE SKYPOINT STENT WAS NOTED TO BE THROMBOSED. ADDITIONAL ANGIOPLASTY WAS PERFORMED, RE-ESTABLISHING BLOOD FLOW. POST PERCUTANEOUS CORONARY INTERVENTION (PCI), OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED TO VISUALIZE THE STENT. NO DISSECTIONS WERE SEEN. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 15332135 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LESION IN THE OBTUSE MARGINAL (OM) ARTERY. A 2.75X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND COULD NOT REACH THE LESION TO BE TREATED. THE DES WAS REMOVED, ALSO WITH RESISTANCE FROM THE ANATOMY, AND A NON-ABBOTT DEVICE 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 14802158 ↗
• MalfunctionJan 19, 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 DISTAL RIGHT CORONARY ARTERY THAT WAS HEAVILY TORTUOUS AND CALCIFIED. A XIENCE SKYPOINT WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL. OTHER DEVICES WERE ATTEMPTED, BUT ALSO DIDN¿T CROSS THE LESION. THERE WAS NO REPORTED 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 13293365 ↗
• InjuryNov 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, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. ANGIOMAX WAS PROVIDED PRE-PROCEDURE. FOLLOWING, A 2.75X28MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUES REPORTED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS IN RECOVERY. A FEW HOURS LATER, THE IMAGING WAS PERFORMED AND THE XIENCE SKYPOINT STENT HAD OCCLUDED WITH THROMBUS. THERE WERE NO ASSOCIATED CLINICAL SYMPTOMS REPORTED. AS TREATMENT, ADDITIONAL ANGIOPLASTY (BALLOON DILATATION) WAS PERFORMED. THE EVENT RESOLVED AND DID NOT REQUIRE PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12836190 ↗
• MalfunctionOct 28, 2021Leak/Splash; Activation Failure; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY. A XIENCE SKYPOINT WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING ATTEMPTED DEPLOYMENT, THE BALLOON WAS INFLATED ONCE AT 10 ATMOSPHERES, BUT FAILED TO INFLATE. THE BALLOON WAS ATTEMPTED TO BE INFLATED FOR DEPLOYMENT OF THE STENT SEVERAL TIMES, BUT CONTINUED TO COMPLETELY FAIL TO INFLATE. THE INFLATION DEVICE WAS REPLACED AND THE BALLOON WAS ATTEMPTED TO BE INFLATED AGAIN BUT FAILED. IT WAS THEN NOTED THAT THE HUB OF THE DEVICE WAS LEAKING. A NEW XIENCE SKYPOINT 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 12712224 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STEMI AND A 2.75X28MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE PATIENT EXPERIENCED CHEST PAIN POST PROCEDURE WHICH WAS REPORTED ON RETURN TO THE CATH LAB ON (B)(6) 2021. STENT THROMBOSIS WAS CONFIRMED BY INTRAVASCULAR ULTRA SOUND (IVUS) AND WAS TREATED BY USING ANGIOPLASTY AND THROMBECTOMY. A STENT WAS PLACED ON THE DISTAL END AND POST-DILATATION WAS PERFORMED USING A 3.25MM NC BALLOON. HOSPITALIZATION WAS EXTENDED; HOWEVER, THE FINAL PATIENT OUTCOME IS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 12636279 ↗