XIENCE Skypoint™ 1804225-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08717648232978), received between Dec 2, 2021 and Mar 8, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS AND THE SDS WAS BEING WITHDRAWN UNDEPLOYED WHEN THE STENT DISLODGED FROM THE BALLOON AND REMAINED IN THE ANATOMY WITHOUT ATTEMPTS AT RETRIEVAL. THE STENT WAS DEPLOYED USING A 1.20X6MM TREK RX COMPLIANT BALLOON AND SERIALLY DILATED UP WITH A 2.5 COMPLIANT BALLOON. A DISSECTION OCCURRED. ADDITIONAL STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELAE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 18867775 ↗
• MalfunctionFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90% STENOSED. A NON-ABBOTT 2.0X10MM BALLOON WAS USED TO DILATE THE LESION. A XIENCE SKYPOINT 2.25X8MM WAS ATTEMPTED TO BE IMPLANTED BUT, ITS STENT BALLOON HAD A PINHOLE RUPTURE AT 8 ATMOSPHERES. THEN, ANOTHER NON-ABBOTT 2.0X10MM WAS USED FOR AN ADDITIONAL INFLATION. A NEW XIENCE SKYPOINT 2.25X12MM WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785199 ↗
• InjuryJun 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE CIRCUMFLEX (CX) ARTERY. THE PATIENT ANATOMY INCLUDED 1 UNSPECIFIED STENT, IMPLANTED APPROXIMATELY 8 MONTHS AGO IN THE LEFT MAIN, AND EXTENDING INTO THE OSTIUM OF THE CX ARTERY. A 3.5 X 15 MM XIENCE SKYPOINT WAS IMPLANTED IN THE CX, A 2.25 X 12 MM XIENCE SKYPOINT WAS IMPLANTED IN THE MID CX AND A 2.5 X 15 MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. IT WAS NOTED THAT A POSSIBLE DISSECTION HAD OCCURRED AT THE PROXIMAL CX; THEREFORE, A 2.25 X 8 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE CX ARTERY, TO TREAT THE DISSECTION. THE XIENCE SKYPOINT WAS ADVANCED TO THE TARGET SITE; HOWEVER, DUE TO INTERACTION WITH THE PREVIOUSLY IMPLANTED LEFT MAIN STENT, THE XIENCE SKYPOINT STENT WAS UNABLE TO CROSS. DURING REMOVAL, THE XIENCE SKYPOINT STENT CAUGHT ON THE LEFT MAIN STENT AND DISLODGED. THERE WERE NO ATTEMPTS TO REMOVE THE DISLODGED STENT, AND THE STENT WAS CRUSHED TO THE VESSEL WALL. AS THE DISSECTION WAS UNABLE TO BE CONFIRMED, NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE POSSIBLE DISSECTION. THE PROCEDURE ENDED WITH THE PATIENT IN STABLE CONDITION. NO ADDI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17148391 ↗
• MalfunctionJul 15, 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 LEFT CIRCUMFLEX ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 2.25X08MM XIENCE SKYPOINT STENT SYSTEM MET RESISTANCE DURING ADVANCEMENT AND FAILED TO REACH THE LESION. DURING REMOVAL, RESISTANCE WAS MET, BUT THE STENT WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED AS REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032982 ↗
• 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, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE FIRST DIAGONAL ARTERY. A 2.25X8MM 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 14802402 ↗
• MalfunctionMar 24, 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 FIRST DIAGONAL(1ST) CORONARY ARTERY WITH MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED WITH A 2.0 BALLOON CATHETER. THEN A 2.25 X 8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM(SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER THE STENT COULD NOT CROSS THE TARGET LESION DUE TO ANATOMICAL CHALLENGES. THE SDS WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE TARGET LESION WAS TREATED WITH ANOTHER XIENCE SKYPOINT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13896089 ↗
• MalfunctionDec 15, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE 1ST DIAGONAL CORONARY ARTERY, 99% STENOSED LESION. THE 2.25X8MM SKYPOINT STENT DELIVERY SYSTEM WAS UNABLE TO ADVANCE, AND WAS DIFFICULT TO REMOVE, BOTH DUE TO THE PATIENTS ANATOMY. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT DELIVERY SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012100 ↗
• MalfunctionDec 2, 2021Break; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Break; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS VESSEL IN THE CIRCUMFLEX ARTERY. THE 2.25X8MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE PLACED DISTALLY IN THE VESSEL AFTER TWO OTHER STENTS WERE ALREADY DEPLOYED IN THE TARGET LESION. HOWEVER, THERE WAS RESISTANCE DURING ADVANCEMENT AND IT WAS NOTED THAT THERE WAS DIFFICULTY CROSSING THE IMPLANTED STENTS. WHEN IT WAS BEING PULLED BACK OUT, THE SDS GOT STUCK AND WAS DIFFICULT TO REMOVE FROM THE GUIDING CATHETER BUT WAS ABLE TO GET THE STENT OUT. THE SDS WAS REMOVED AS A SINGLE UNIT. THE STENT WAS NOTED TO BE FLARED AND SOME STENT STRUTS FRACTURED BUT NOT SEPARATED. THE PROCEDURE WAS STOPPED AT THIS POINT AND PATIENT SCHEDULED FOR ANOTHER STENTING ATTEMPT. 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 12920935 ↗