XIENCE Skypoint™ 1804250-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08717648233104), received between Mar 25, 2021 and Jul 7, 2025 — classified as 1 death, 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 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 LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, THE 2.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCE WITH DIFFICULTY TO THE TARGET LESION DUE TO THE ANATOMY. THE STENT WAS ATTEMPTED TO BE IMPLANTED; HOWEVER, THE BALLOON OF THE SDS RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE STENT REMAINED ON THE DELIVERY SYSTEM AND WAS ABLE TO BE REMOVED WITH THE DELIVERY SYSTEM WITHOUT ISSUE ADDITIONAL DILATATION WAS PERFORMED FOLLOWED BY IMPLANTATION OF A NON-ABBOTT STENT 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 22420287 ↗
• MalfunctionMar 11, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION OR TORTUOSITY. THE 3.0X23 AND 2.5X28 MM XIENCE SKYPOINT STENTS WERE IMPLANTED. PLANNED ASPIRATION WAS THEN PERFORMED BUT THIS CAUSED THE STENTS TO BECOME DAMAGED AND THEY WERE UNEXPECTEDLY PULLED OUT WITH THE ASPIRATION CATHETER. THEN TWO NON-ABBOTT STENTS WERE USED TO TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574986 ↗
• InjuryFeb 18, 2025Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Material Deformation; Activation Failure; Difficult to Remove; Material Rupture; Device Dislodged or Dislocated; Material Deformation; Activation Failure

  SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE LESION WAS HEAVILY CALCIFIED. THE BALLOON RUPTURE WAS NOTED DURING THE FIRST INFLATION OF THE SDS TO APPROXIMATELY 4-6 ATMOSPHERES. THE STENT APPEARED FLARED AND THERE WAS RESISTANCE DURING REMOVAL INTO THE GUIDING CATHETER SO ALL DEVICES WERE REMOVED AS A SINGLE UNIT AND THE STENT DISLODGED DURING THE ATTEMPT TO PULL IT BACK INTO THE GUIDING CATHETER. THE STENT WAS REMOVED VIA CUT DOWN AT THE OTHER HOSPITAL. ADDITIONALLY, MEDWATCH MW5165908 RECEIVED WHICH STATES: CORONARY STENT ATTEMPTED TO BE IMPLANTED, THE STENT BALLOON BURST AT INITIAL INFLATION, RESULTING IN A FREE-FLOATING STENT. THE STENT WAS NOT ABLE TO BE RETRIEVED. THE PATIENT HAD TO BE TRANSFERRED TO A VASCULAR SURGEON TO HAVE THE STENT REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394318 ↗
• MalfunctionAug 23, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 2.5X28MM XIENCE SKYPOINT STENT DISLODGED AFTER REMOVING THE STYLET. A NEW XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. A 2.5X28MM XIENCE SKYPOINT DEVICE WAS RECEIVED AS THE DEVICE RECEIVED STILL HAS THE STENT AND STYLET ON THE DEVICE THIS IS NOTED TO BE THE INCORRECT DEVICE. THE STENT DELIVERY SYSTEM WAS SEPARATED 5MM DISTALLY FROM THE GUIDE WIRE NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052125 ↗
• MalfunctionJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 2.5X28MM XIENCE SKYPOINT STENT DISLODGED AFTER REMOVING THE STYLET. A NEW XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751664 ↗
• MalfunctionDec 13, 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 MID RIGHT CORONARY ARTERY (MRCA) WITH 99% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL BUT WAS REMOVED INDEPENDENTLY. ANOTHER DEVICE 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 18319000 ↗
• MalfunctionMay 17, 2023Material Rupture; Material Rupture

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED THE XIENCE SKYPOINT RUPTURED DURING THE FIRST INFLATION AT 16 ATMOSPHERES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16948073 ↗
• InjuryOct 21, 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 MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). MEDICATIONS WERE PROVIDED AND A 2.5X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS PLACED IN THE MRCA, AND A 3X15MM SKYPOINT DES WAS PLACED PROXIMAL TO THAT STENT. A 3.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION AND THE PATIENT WAS TRANSFERRED TO THEIR ROOM FOR RECOVERY. APPROXIMATELY 2 MINUTES AFTER THE PATIENT WAS TRANSFERRED TO THEIR ROOM, AND EXPERIENCED CHEST PAIN. AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED WHICH INDICATED AN ST-ELEVATION MYOCARDIAL INFARCTION. THE PATIENT WAS IMMEDIATELY PLACED BACK IN THE CATH LAB FOR THE SECOND TIME THAT DAY. UPON ENGAGING THE RCA WITH A GUIDE CATHETER (GC) IT WAS DISCOVERED THERE WAS A HEAVY THROMBUS THROUGHOUT THE LENGTH OF THE VESSEL, INSIDE AND OUTSIDE OF THE RECENTLY IMPLANTED STENTS. MEDICATIONS WERE PROVIDED AND A 3.5X15MM SKYPOINT DES AND A 3.0X15MM SKYPOINT DES WERE IMPLANTED PROXIMAL TO THE INITIAL 2 STENTS IN THE MRCA. POST-DILATATION WAS PERFORMED. AFTER THE PROCEDURE WAS COMPLETED, THE ACT RESULTED AT 248 SECONDS. THE PATIENT WAS STABLE WITHOUT CHEST

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 15655971 ↗
• DeathJul 29, 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 LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY ARTERY (RCA). TWO XIENCE SKYPOINT STENTS WERE IMPLANTED, WITHOUT ISSUE IN THE LAD (2.25X38MM, 2.5X28MM), AND ONE STENT IMPLANTED IN THE RCA (3.5X33MM). THE PATIENT WAS SENT TO RECOVERY BUT APPROXIMATELY AN HOUR AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS STARTED AND THE PATIENT WAS TAKEN BACK TO THE CATH LAB. AT THAT POINT, IT WAS NOTED THAT THE 2.5X28MM XIENCE SKYPOINT STENT, IMPLANTED IN THE MID TO DISTAL LAD WAS OCCLUDED WITH A TIMI FLOW GRADE OF ZERO. BALLOONING WAS DONE TO TRY TO OPEN THE VESSEL, BUT EVERYTHING WAS STOPPED DUE TO THE LOW CHANCE OF RECOVERY AND THE PATIENT¿S AGE AND THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Cardiac Arrest; Obstruction/Occlusion

  MAUDE report 15135703 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE DIAGONAL ARTERY. THE 2.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE LESION DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED INDEPENDENTLY. THERE WAS RESISTANCE DURING REMOVAL. 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 14793769 ↗
• MalfunctionJun 13, 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 DISTAL RIGHT CORONARY ARTERY (DRCA) THAT IS 90% STENOSED. THE 2.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL OF THE SDS WITH ANATOMY. NO OTHER DEVICE WAS USED AS NO OTHER DEVICE WAS ABLE TO CROSS AND NO OTHER TREATMENT PROVIDED. 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 14681175 ↗
• InjuryMar 25, 2022Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE SKYPOINT 2.5MM X 28MM STENT SYSTEM ADVANCED WITHOUT ISSUE AND WAS IMPLANTED. AFTER POST-DILATATION, A DISSECTION AND STENT FRACTURED WERE NOTED. A SKYPOINT 3.5X12 STENT WAS IMPLANTED TO TREAT THE DISSECTION AND STENT FRACTURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT WAS NOTED AS DOING GREAT WITH NO ISSUES OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 13910215 ↗
• MalfunctionMar 18, 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 DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT IS 99% STENOSED. THE 2.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS FELT DURING REMOVAL OF THE SDS. ANOTHER NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803231 ↗
• MalfunctionMar 11, 2022Difficult 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) WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. A 2.50 X 28 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS FELT DUE TO ANATOMICAL CHALLENGES, AND THE STENT COULD NOT CROSS THE TARGET LESION. THEREFORE, SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMICAL CHALLENGES. A NON-ABBOTT STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WERE NO ADVERSE PATIENT EFFECTS OR NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13739032 ↗
• MalfunctionFeb 24, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). A 2.5X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION AND THE STENT IMPLANTED. AFTER STENT IMPLANTATION, THE XIENCE SKYPOINT BALLOON WAS ATTEMPTED TO BE USED FOR POST-DILATATION, BUT THE BALLOON WOULD ONLY INFLATE TO 8 ATMOSPHERES (ATM). THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT BALLOON WAS ADVANCED TO COMPLETE POST-DILATATION, WITHOUT ISSUE, 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 13592926 ↗
• MalfunctionApr 2, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS DISTAL RIGHT CORONARY ARTERY. USING AN EXTENSION CATHETER, THE 2.50X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY. RESISTANCE WITH THE ANATOMY WAS ALSO MET DURING REMOVAL. THE DISTAL TIP WAS THEN NOTED TO BE FLARED. A NEW XIENCE 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 11608379 ↗
• InjuryMar 25, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT CORONARY ARTERY THAT WAS MILDLY CALCIFIED, MODERATELY TORTUOUS AND 75% STENOSED. AFTER PRE-DILATATION, THE XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION. DURING DEPLOYMENT, THE BALLOON RUPTURED AT 10 ATMOSPHERES. ADDITIONAL BALLOON INFLATIONS WERE REQUIRED TO DEPLOY THE STENT. ANOTHER PLANNED XIENCE SKYPOINT WAS THEN IMPLANTED AND BOTH STENTS WERE POST-DILATATED WITH TWO NON-ABBOTT BALLOONS. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11572960 ↗