XIENCE Skypoint™ 1804400-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08717648233524), received between Jul 27, 2021 and Apr 15, 2024 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THE 4.0X38MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS PREPARED FOR USE PRIOR TO REMOVING THE PROTECTIVE SHEATH. SLIGHT RESISTANCE WAS NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS NOTED TO BE ELONGATED AT THE DISTAL END. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105226 ↗
• MalfunctionOct 3, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT BE PROPERLY IMPLANTED DUE TO THE PLAQUE AS THE DEVICE WAS INFLATED TO 8-12 ATMOSPHERES; HOWEVER, WOULD NOT INFLATE. THE STENT WAS NOTED TO BE FLARED. ANOTHER STENT WAS A DIAMETER OF 3.5MM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS 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 17864925 ↗
• InjurySep 21, 2023Failure 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 RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. A 6F GUIDING CATHETER WAS MODIFIED WITH SIDE HOLES USING A NEEDLE (INNER LUMEN PIECE MOST LIKELY PROTRUDING OUT) AND TWO XIENCE SKYPOINT STENT DELIVERY SYSTEMS (SDS), A 4.0X12MM AND 4.0X38MM. THE TWO XIENCE SKYPOINT SDS HAD RESISTANCE WITH THE GUIDING CATHETER DUE TO THE MODIFICATION AND WAS NOTED TO HAVE FLARED STRUTS. THE DELIVERY SYSTEMS WERE SIMPLY REMOVED. ANOTHER 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT HAD RESISTANCE WITH THE ANATOMY AND THE STENT GOT LOOSE ON THE BALLOON. THE STENT WAS MANAGED TO BE PULLED BACK AND THE BALLOON WAS INFLATED IN THE GUIDING CATHETER AS A BAIL OUT. THREE STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE 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 17795302 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. ATHERECTOMY WAS SUCCESSFULLY PERFORMED WITH A DIAMONDBACK 360. TWO XIENCE STENTS (4.0X38MM AND 4.0X28MM) WERE THEN ADVANCED AND IMPLANTED SUCCESSFULLY AND POST DILATATION WAS PERFORMED. A PERFORATION WAS OBSERVED AFTER POST DILATATION AT THE PROXIMAL RCA WHERE THE 4.0X38MM STENT WAS IMPLANTED. A 4X20MM NON-ABBOTT STENT WAS USED TO SUCCESSFULLY TREAT THE PERFORATION. NO PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS STABLE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 17646500 ↗
• MalfunctionApr 11, 2023Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT WHILE AN UNSPECIFIED GUIDE WIRE WAS IN THE ANATOMY, THE 4.0X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED OVER THE GUIDE WIRE BUT IT BECAME STUCK AS THE GUIDE WIRE WASN'T WIPED PRIOR TO ADVANCEMENT. DURING ADVANCEMENT, THE NOSE CONE SEPARATED. THE DEVICE AND NOSE CONE WERE SUBSEQUENTLY REMOVED FROM THE WIRE AND THE WIRE REMAINED IN PLACE. THERE WAS ALSO RESISTANCE WHEN REMOVING THE XIENCE SKYPOINT SDS FROM THE GUIDE WIRE. THE SDS NEVER MADE IT INTO THE ANATOMY. 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 16714499 ↗
• InjuryDec 15, 2022Leak/Splash; Difficult to Remove; Material Rupture; Difficult or Delayed Activation; Device Dislodged or Dislocated; Migration; Leak/Splash; Difficult to Remove; Material Rupture; Difficult or Delayed Activation; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT MAIN CORONARY ARTERY (LM) AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS NOTED TO RUPTURE AT 5 ATMOSPHERES; HOWEVER, THE STENT WAS DEPLOYED DOG BONE SHAPED. THE SDS WAS DEFLATED, REMOVED WITH RESISTANCE MET WITH THE STENT AND THE STENT MOVED TO THE PROXIMAL PART OF THE LESION. POST-DILATATION WAS PERFORMED TO DEPLOY THE STENT COMPLETELY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15987570 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS HOSPITALIZED WITH A NON ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). A 4.0X38MM XIENCE SKYPOINT STENT WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF CHEST PAIN AND SHORTNESS OF BREATH. STEMI WAS DIAGNOSED AND THE PATIENT WAS RE-HOSPITALIZED. PERCUTANEOUS CORONARY INTERVENTION AND THROMBECTOMY WERE PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 15749830 ↗
• MalfunctionAug 30, 2022Difficult to Insert; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Insert; Stretched; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A 4X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED IN A 6F GUIDE CATHETER (GC) BUT COULD NOT REACH THE TARGET LESION DUE TO THE ANATOMY. THE DES AND 6F GC WERE REMOVED AND A 7F GC WAS THEN POSITIONED. DURING RE-INSERTION ONTO THE GUIDE WIRE, THE TIP OF THE DES WAS NOTED TO BE STRETCHED BY APPROXIMATELY 2 CENTIMETERS (CM) AND COULD NOT BE INSERTED ONTO THE GUIDE WIRE (GW), SO THE TIP OF THE DES WAS CUT AND THEN WAS ABLE TO BE INSERTED ONTO THE GW, ADVANCED TO THE TARGET LESION AND THE STENT IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS NOTED THAT THE INNER MEMBER WAS STRETCHED PROXIMAL TO THE DISTAL TAPERED PORTION OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322740 ↗
• InjuryJul 27, 2022Improper or Incorrect Procedure or Method; Difficult or Delayed Activation; Improper or Incorrect Procedure or Method; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH OCCLUSION AND 3 AREAS OF HIGH GRADE STENOSIS. A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS USED TO CROSS THE LESIONS IN THE RIGHT CORONARY ARTERY AND INTO THE POSTEROLATERAL BRANCH. A 4.0X38 MM XIENCE SKYPOINT STENT WAS POSITIONED OVER THE FIRST 2 STENOSES AND DEPLOYED AT 18 ATMOSPHERES (ATM). THERE WAS WAIST SEEN IN THE MIDDLE OF THE STENT AND ANGIOGRAM POST STENT DEPLOYMENT SHOWED A PERFORATION AT THE DISTAL EDGE OF THE STENT. THE STENT BALLOON WAS ADVANCED AND INFLATED TO 4 ATM FOR ABOUT 5 MINUTES. THE LEAK WAS DECREASED BUT STILL PRESENT SO ANOTHER INFLATION WAS PERFORMED FOR 5 MINUTES. THE BMW GUIDE WIRE WAS THEN MOVED IN A PARALLEL FASHION TO THE VEIN GRAFT. AT THIS TIME THERE WAS MINIMAL EXTRAVASATION OF DYE AT THE PERFORATION SITE SO THE DISTAL PORTION OF THE LESION WAS TREATED WITH A 3.5X18 MM XIENCE SKYPOINT STENT DEPLOYED AT 12 ATM. POST DILATATION WAS PERFORMED WITH A 4.0X12 MM BALLOON AND THE BALLOON WAS THEN USED FOR THE PERFORATION SITE FOR 8 MINUTES. ANGIOGRAM FOLLOWING THIS SHOWED EXTRAVASATION OF CONTRAST AND TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED PERSISTENT PERICARDIAL EFFUSION. THE

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 15117055 ↗
• InjuryFeb 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PROXIMAL RIGHT CORONARY ARTERY. A 4X38MM XIENCE SKYPOINT WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHEN ATTEMPTING TO IMPLANT THE STENT, THE VESSEL PUSHED IT BACK TO A MORE RECOILED POSITION. ADDITIONAL POST-DILATATION WAS PERFORMED AND AN ADDITIONAL UNSPECIFIED STENT WAS IMPLANTED OVERLAPPING. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13569519 ↗
• MalfunctionFeb 15, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY. THE SDS WAS REMOVED AND ATTEMPTED TO BE RE-INSERTED WITH A NON-ABBOTT TELESCOPE EXTENSION CATHETER; HOWEVER, THE SDS BECAME STUCK INSIDE THE GUIDE EXTENSION AND THE STENT IMPLANT SLID OFF THE BALLOON; HOWEVER, REMAINED ON THE DELIVERY SYSTEM. THE SDS WAS REMOVED ALONG WITH THE STENT AND EXTENSION CATHETER AS ONE UNIT. ANOTHER SMALLER SIZE XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WASP PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538665 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 99%STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS. THERE WAS ALSO RESISTANCE WITH THE ANATOMY DURING REMOVAL. THERE WERE NO OTHER DEVICE ISSUES. 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. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE DEVICE WAS REMOVED INDEPENDENTLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955036 ↗
• MalfunctionDec 3, 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, 90% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). A 4X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND THE DES COULD NOT REACH THE TARGET LESION TO BE TREATED. THE DES WAS REMOVED WITH RESISTANCE 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 12929805 ↗
• MalfunctionOct 13, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS AND CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X38MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION MULTIPLE TIMES AND THE PROXIMAL SHAFT BROKE. THE DEVICE WAS SIMPLY REMOVED FROM THE PATIENT WITH THE GUIDING CATHETER. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624404 ↗
• InjurySep 22, 2021Difficult to Remove; Material Rupture; Material Deformation; Activation Failure; Difficult to Remove; Material Rupture; Material Deformation; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT IS 75% STENOSED. AN UNSPECIFIED 6FR GUIDING CATHETER WAS USED TO ADVANCE A NON-ABBOTT BALLOON CATHETER THAT WAS PLACED AT THE PERIPHERAL TO PERFORM A BALLOON ANGIOPLASTY. THE 4.0X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND AT THE LESION WAS ATTEMPTED TO BE INFLATED; HOWEVER, PRESSURE DID NOT INCREASE MORE THAN 2-4 ATMOSPHERES. IT WAS NOTED THE BALLOON MIGHT HAVE RUPTURED. FLUOROSCOPY CONFIRMED THE STENT BALLOON PROXIMAL WAS PARTIALLY INFLATED. THE DEVICE WAS DEFLATED AND NEGATIVE PRESSURE WAS APPLIED TO CONFIRM BACKFLOW. THE SDS WAS ATTEMPTED TO BE RETRIEVED INTO THE GUIDING CATHETER, BUT FAILED AS THE PROXIMAL PART OF THE STENT WAS FLARED. ADDITIONALLY, ANOTHER ACCESS SITE IN THE FEMORAL WAS CREATED TO TREAT THE LAD WITH AN UNSPECIFIED 8F GUIDE CATHETER AND A NON-ABBOTT STENT WAS IMPLANTED. THEN AN UNSPECIFIED 8F GUIDE CATHETER WAS ADVANCED TO THE SUBCLAVIAN AND AN UNSPECIFIED DEVICE WAS USED TO SNARE THE SDS AND REMOVED EVERYTHING AS A SINGLE UNIT. THE FOLLOWING DAY, A HEMATOMA WAS NOTED AT THE FEMORAL ACCESS SITE. AN ADDITIONAL ANGIOGRAM WAS TAKEN AND MANUAL COMPRES

  Patient problems: Hematoma

  MAUDE report 12513874 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 99% STENOSED LESION LOCATED IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER ROTABLATION, A XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED TOWARD THE LESION, BUT ENCOUNTERED SOME CALCIFICATION, RESULTING IN FLARED STRUTS AND A FAILURE TO CROSS THE LESION. RESISTANCE WAS NOTED DURING REMOVAL, BUT THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235743 ↗