XIENCE Skypoint™ 1804250-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08717648231261), received between Dec 9, 2021 and Apr 8, 2026 — classified as 3 injuries, 16 malfunctions.

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

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT THE TARGET LESION WAS A 99% STENOSED SEVERELY CALCIFIED PROX-MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION MEASURING 3.0 X 40 MM. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT 2.5 X 20 MM NON-COMPLIANT (NC) BALLOON, THE LESION WAS 70% STENOSED. A 2.5 X 12 MM IVL (INTRAVASCULAR LITHOTRIPSY) CATHETER WAS TRACKED TO THE PROXIMAL PORTION OF THE LESION AND 80 PULSES WERE DELIVERED. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE SECOND 2.5 X 12 MM IVL CATHETER TO THE DISTAL PORTION. HOWEVER, IT COULD NOT CROSS, SO HE DILATED WITH A NON-ABBOTT 2.5 X 12 MM NC BALLOON IN THE DISTAL POSITION OF THE LESION (12 ATMOSPHERES (ATM) FOR 4 SEC). THE SECOND IVL 2.5 X 12 MM CATHETER WAS THEN TRACKED TO THE DISTAL PORTION OF THE LESION WITH 10 PULSES DELIVERED IN AN OVERLAP OF 2-3MM OF THE MOST DISTAL SECTION OF THE LESION THAT WAS TREATED WITH THE FIRST IVL CATHETER. THE REMAINING 70 PULSES WERE DELIVERED TO THE MOST DISTAL PORTION OF THE LESION. THE STENOSIS IMMEDIATELY POST IVL WAS 60%. HE THEN POST-DILATED WITH A 2.5 X 12 MM NC BALLON (12 ATM FOR 4 SEC, 12 ATM FOR 5 SEC, AND 15 ATM FOR 2 SEC). IT WAS THEN NOTED THAT THERE WAS A DISSECTION IN THE MID LAD

  Patient problems: Cardiac Enzyme Elevation; Vascular Dissection

  MAUDE report 24816089 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) FROM THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). THE 2.5X48MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE MID-DISTAL RCA AND A 3X38MM XIENCE SKYPOINT STENT WAS IMPLANTED OVERLAPPING IN THE PROXIMAL RCA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ISSUES WERE REPORTED AT THE 1 MONTH AND 1 YEAR FOLLOW-UPS. ON (B)(6) 2024, THE PATIENT REPORTED CHEST PAIN. CORONARY ANGIOGRAM WAS PERFORMED AND 90% IN-STENT RESTENOSIS (ISR) WAS CONFIRMED IN THE DISTAL RCA. THE PATIENT WAS PLACED ON ANTIPLATELET MEDICATION AND ON (B)(6) 2024, REVASCULARIZATION WAS PERFORMED. THE ISR WAS TREATED WITH A DRUG-COATED BALLOON AND THE PATIENT WAS PLACED ON ADDITIONAL MEDICATION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 19015723 ↗
• MalfunctionDec 27, 2023Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 99% STENOSIS. THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPPED PER INSTRUCTIONS AND ADVANCED TO THE LESION. NO RESISTANCE WAS NOTED. PRESSURE WAS APPLIED AT ABOUT 6 ATMOSPHERES; HOWEVER, THE BALLOON DID NOT INFLATE AND THEREFORE THE STENT FAILED TO DEPLOY. IT WAS FOUND THAT THE BALLOON WAS RUPTURED. THE SDS WAS REMOVED FROM THE ANATOMY WITH THE STENT INTACT ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE XIENCE SKYPOINT SDS. 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 18406145 ↗
• MalfunctionJul 26, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION. THERE WAS RESISTANCE DURING REMOVAL WITH THE ANATOMY AND ALL DEVICES WERE REMOVED AS A SINGLE UNIT; HOWEVER, THERE WAS NO RESISTANCE WITH OTHER DEVICES. THE PROCEDURE WAS COMPLETED WITHOUT DEPLOYMENT OF A STENT. 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 17398387 ↗
• MalfunctionMar 28, 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 RIGHT POSTERIOR DESCENDING ARTERY (RPDA) THAT IS 90% STENOSED. THE 2.5X48MM XIENCE SKYPOINT STENT DELIVER SYSTEM (SDS) FAILED TO CROSS WITH THE USE OF AN UNSPECIFIED EXTENSION CATHETER DUE TO RESISTANCE WITH ANATOMY. RESISTANCE DURING REMOVAL OF THE SDS WAS FELT WITH ANATOMY. A DRUG COATED BALLOON 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 16630912 ↗
• MalfunctionMar 23, 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 RIGHT CORONARY ARTERY (RCA). A 2.50X48MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16605491 ↗
• MalfunctionFeb 22, 2023Difficult 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 CALCIFIED, MODERATELY TORTUOUS AND 90% STENOSED. THE 2.50X48MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS MET, BUT THE DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS FINISHED WITHOUT FURTHER TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16424380 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. AFTER PRE-DILATATION THE 2.50X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THER TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED AND DIFFICULTY WAS NOTED ALSO DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A DRUG COATED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929035 ↗
• MalfunctionJun 24, 2022Difficult 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 RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE FIRST 2.50X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMY. THEN A SECOND 3.00X48MM XIENCE SKYPOINT SDS WAS ATTEMPTED TO ADVANCE TO THE TARGET LESION; HOWEVER, ALSO COULD NOT BE ADVANCED DUE TO THE ANATOMY. THE SECOND SDS WAS REMOVED ALSO WITH DIFFICULTY DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT OR NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USE COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808206 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance; Difficult to Remove; Material Too Rigid or Stiff; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS POSTERIOR DESCENDING ARTERY (PDA) THAT IS 99% STENOSED. DURING ADVANCEMENT OF THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH ANATOMY AS WELL AS DURING REMOVAL OF THE SDS. IN THE PHYSICIAN'S OPINION THE NO CROSS WAS DUE TO THE STENT NOT BEING FLEXIBLE ENOUGH. A NON-ABBOTT STENT 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 14793356 ↗
• InjuryApr 15, 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 MID LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2022, THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED. ON (B)(6) 2022, THROMBOSIS WAS NOTED BY INTRAVASCULAR ULTRASOUND (IVUS). BALLOON DILATATION WAS PERFORMED AND UNSPECIFIED XIENCE WAS IMPLANTED TO TREAT THE THROMBUS. THERE WERE NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14118061 ↗
• MalfunctionFeb 7, 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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL WITH ANATOMY AND ONCE WITHDRAWN THE TIP WAS OBSERVED TO BE BENT. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON AND A NEW 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 13476669 ↗
• MalfunctionDec 21, 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 TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED DEVICE AND THE 2.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED DUE TO ANATOMY. DILATATION WAS PERFORMED AGAIN AND THE SDS WAS ATTEMPTED TO BE ADVANCED, BUT STILL FAILED TO CROSS DUE TO ANATOMY. RESISTANCE DURING REMOVAL OF THE SDS WAS NOTED WITH ANATOMY. ANOTHER UNSPECIFIED 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 13053623 ↗
• MalfunctionDec 18, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS 1ST OBTUSE MARGINAL CORONARY ARTERY. THE 2.50X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO ADVANCE TO THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. 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 13040081 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 99% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS OBTUSE MARGINAL CORONARY ARTERY. THE 2.5X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. A NON-ABBOTT SDS 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 13005746 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 90% STENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS DIFFICULTY REMOVING THE DEVICE. A NON-ABBOTT 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 13005676 ↗
• MalfunctionDec 14, 2021Difficult 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, 99% STENOSED, DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 2.5X48MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO THE ANATOMY. THE DES WAS REMOVED WITH RESISTANCE MET 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 13003563 ↗
• MalfunctionDec 9, 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 DISTAL RIGHT CORONARY ARTERY (DRCA). A 2.5X48MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) FAILED TO CROSS THE ANATOMY TO REACH THE TARGET LESION. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS MET WITH THE ANATOMY. A NON-ABBOTT STENT WAS ABLE TO CROSS 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 12973053 ↗
• MalfunctionDec 9, 2021Difficult 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, 99% STENOSED, DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). A 2.5X48MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO THE ANATOMY. THE DES WAS REMOVED WITH RESISTANCE MET 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 12972039 ↗