XIENCE Skypoint™ 1804350-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648231308), received between Jun 13, 2024 and Jun 17, 2026 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY LESION. A 3.5X48 MM XIENCE SKYPOINT DRUG-ELUDING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION. HOWEVER, IT FAILED TO CROSS THE LESION. A GUIDELINER WAS INSERTED AND THE DES WAS ADVANCED AGAIN. HOWEVER, IT AGAIN FAILED TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED BETWEEN THE SDS AND GUIDLINER, CAUSING THE EDGES OF THE STENT TO BE MANGLED. BOTH DEVICES WERE REMOVED TOGETHER. A NEW 3.5X48 MM XIENCE SKYPOINT SDS AND GUIDELINER WERE 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 25539582 ↗
• MalfunctionMay 12, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 71% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION. THE 3.5 X 48 MM XIENCE SKYPOINT STENT WAS IMPLANTED ALTHOUGH THE STENT WAS NOTED TO BE EXPIRED. 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 25156786 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X48 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THE STENT FRACTURED IN 2 PLACES. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839366 ↗
• MalfunctionDec 1, 2025Off-Label Use; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Off-Label Use; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION. THE 3.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE TARGET LESION WHEN THE SDS BECAME SNAGGED ON THE GUIDE WIRE (GW). THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT; HOWEVER, DURING REMOVAL THE STENT CAME OFF THE BALLOON AND AS A RESULT , THE DISLODGED STENT AND THE DELIVERY SYSTEM GW WERE REMOVED AS A SINGLE UNIT. 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 23684146 ↗
• MalfunctionOct 15, 2025Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WERE NO BROKEN STRUTS, THEY WERE BENT. THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23281133 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). FOLLOWING ORBITAL ATHERECTOMY USING A DIAMONDBACK DEVICE, A 3.50 X 48MM XIENCE SKYPOINT DRUG ELUTING STENT WAS SUCCESSFULLY IMPLANTED AT THE LESION; HOWEVER, DURING POST-DILATATION USING A NC TREK BALLOON DILATATION CATHETER (DC), A PERFORATION WAS NOTED AND LOCATED WITHIN THE DEPLOYED STENT. THE PERFORATION WAS TREATED BY HOLDING COMPRESSION WITH THE NC TREK BDC AND PERFORMING PERICARDIOCENTESIS. A CLINICAL DELAY WAS NOTED AND THE PATIENT WAS REPORTED TO HAVE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 22889363 ↗
• MalfunctionMay 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ATTEMPTED TO BE USED BUT COULD NOT BE RECOGNIZED DISPLAYING MESSAGE "CATHETER NOT RECOGNIZED BY DEVICE" WITHOUT ERROR CODE. ANOTHER DRAGONFLY OPSTAR WAS USED INSTEAD TO CONTINUE THE PROCEDURE. THE 3.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS THEN BEING PREPARED WHEN THE STENT FELL OFF THE BALLOON. THE SDS WAS NOT USED IN THE PATIENT. A 3.5X38MM XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY. THE 3.5X23MM XIENCE SKYPOINT SDS WAS BEING ADVANCED WITHOUT RESISTANCE WHEN THE STENT WAS NOTED TO BE DEFORMED ON THE BALLOON AND FAILED TO CROSS. A 3.5X18MM XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY. 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 22087521 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. A 3.50X48MM AND A 3.50X38MM XIENCE SKYPOINT STENTS WERE IMPLANTED WITHOUT ISSUE. AT THE END THE PROCEDURE, THE PATIENT WAS AWAKE, ALERT, AND IN RECOVERY WITH FAMILY. HOWEVER, LATER THAT DAY THE PATIENT CODED AND WAS BROUGHT BACK TO THE CATH LAB WHERE ANGIOGRAPHY SHOWED THROMBUS IN THE LEFT MAIN (LM). A GUIDE WIRE WAS PLACED AND THROMBECTOMY WAS ATTEMPTED HOWEVER THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 21677040 ↗
• MalfunctionJan 6, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF THE 3.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), WHEN THE STYLET WAS REMOVED, THE STENT MOVED COMPLETELY OFF THE DELIVERY BALLOON AND THE STRUTS WERE NOTED TO BE FLARED. THEREFORE, THE SDS WAS NO USED IN THE PATIENT. ANOTHER SAME SIZE XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080654 ↗
• MalfunctionAug 22, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING LOADED ONTO THE GUIDE WIRE AND CONNECTED TO THE INDEFLATOR WHEN IT WAS NOTED THAT THE STENT WAS ON THE TABLE. ANOTHER 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 20034401 ↗
• MalfunctionJun 13, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.5X48MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED DUE TO THE ANATOMY AND RESISTANCE WITH THE GUIDELINER. THE SDS WAS REMOVED AND THE LESION WAS SHOCK WAVED. AN ADDITIONAL ATTEMPT WAS MADE TO CROSS THE SDS WITH THE USE OF A BUDDY WIRE, BUT WAS UNSUCCESSFUL. ADDITIONAL DILATATION WAS PERFORMED AND THE SDS WAS ATTEMPTED AGAIN, BUT WOULD NOT EXIT THE GUIDELINER. DURING REMOVAL, RESISTANCE WAS MET WITH THE GUIDE LINER. AFTER REMOVAL, THE DISTAL EDGE OF THE STENT BECAME FLARED. THE PROCEDURE WAS COMPLETED WITH 2 NON-ABBOTT STENTS. THERE WERE 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 19530007 ↗