XIENCE Skypoint™ 1804350-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648233432), received between Mar 25, 2021 and Aug 6, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Device Dislodged or Dislocated

  It was reported that the procedure was to treat a lesion in the right coronary artery (RCA). A bend and calcium was located in the proximal anatomy and a dual guide wire technique was used for support; however, no resistance during advancement was reported. The 3.5x33mm Xience Skypoint stent delivery system (SDS) was attempted to be used in the procedure; however, the stent became dislodged. Therefore, the patient was transferred another hospital for bypass surgery of other vessels and removal of the stent. No additional information was provided.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161473 ↗
• InjuryJun 5, 2026Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.50 X 33 MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS IMPLANTED. UPON REMOVAL OF AN UNSPECIFIED GUIDE WIRE IN A SECONDARY BRANCH, THE DES WAS EXPLANTED AND LOCATED IN THE PATIENT'S RIGHT BRACHIAL ARTERY. A 3.5 X 38 MM XIENCE DES WAS IMPLANTED IN THE LAD TO REPLACE THE EXPLANTED STENT. THE PATIENT WAS CURRENTLY ADMITTED AND HEPARINIZED OVERNIGHT. THE FOLLOWING DAY ((B)(6) 2026), THE PATIENT UNDERWENT A CUTDOWN AND THE 3.50 X 33 MM DES WAS SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410955 ↗
• MalfunctionJan 8, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A THROMBUS IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS BEING ADVANCED WITHOUT RESISTANCE WHEN ON FLUOROSCOPY, THE STENT WAS NOTED TO HAVE DISLODGED TO THE PROXIMAL MARKER. THERE WAS NO RESISTANCE DURING REMOVAL AND THE STENT REMAINED ON THE DELIVERY SYSTEM. HOWEVER, THE STENT SOMEHOW CAME OFF THE DELIVERY SYSTEM ONCE OUTSIDE THE ANATOMY. ANOTHER XIENCE SKYPOINT 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 24000295 ↗
• MalfunctionAug 18, 2025Material Rupture; Difficult to Advance; Device Dislodged or Dislocated; Material Rupture; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED. THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM HAD RESISTANCE DURING ADVANCEMENT BUT SUCCESSFULLY CROSSED THE LESION. AN INITIAL INFLATION OF 6 ATMOSPHERES (ATMS) WAS PERFORMED; HOWEVER, A RUPTURE OCCURRED. THE STENT REMAINED MOUNTED BUT A LITTLE OUT OF POSITION AND THE SYSTEM WAS RETRIEVED WITHOUT ISSUES. ADDITIONAL DILATATIONS WERE PERFORMED USING A 3.5X15MM NON-ABBOTT BALLOON PER STANDARD PROCEDURE. THE STENT WAS CHANGED TO A 3.25X33MM XIENCE SKYPOINT STENT AND SUCCESSFULLY IMPLANTED. POST-DILATION WITHIN THE STENT WAS PERFORMED SEVERAL TIMES USING THE 3.5X15MM NON-ABBOTT BALLOON, RESULTING IN GOOD EXPANSION AND COMPLETING 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 22829914 ↗
• MalfunctionJul 30, 2025Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD). FOLLOWING EXTENSIVE PRE-DILATATION WITH A 2.75X15MM AND 3.0X15MM NON-ABBOTT BALLOON CATHETERS, A 3.50X33MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS ATTEMPTED TO BE ADVANCED TO THE LESION; HOWEVER, FAILED TO CROSS DUE TO THE CALCIFICATION. THEREFORE, THE DES WAS REMOVED AND THE SAME DES WAS LOADED ONTO A NON-ABBOTT GUIDE EXTENSION CATHETER AND READVANCED TO THE LESION THROUGH RESISTANCE WITH THE ANATOMY. THE DES WAS ABLE TO CROSS THE LESION; HOWEVER, DURING A DEPLOYMENT ATTEMPT THE BALLOON WAS NOTED TO RUPTURE AT 6 ATMS. THE STENT REMAINED ON THE BALLOON; THEREFORE, THE ENTIRE SYSTEM WAS REMOVED FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED WITH THE USE OF ADDITIONAL DILATATION, AND THE IMPLANTATION OF A 3.25X18MM AND 3.5X18MM XIENCE SKYPOINT. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668479 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.5X33MM XIENCE SKYPOINT STENT WAS IMPLANTED HOWEVER DURING POST DILATATION WITH A 3.50X8MM NC TREK BALLOON, UPON EXPANDING THE PROXIMAL AREA OF THE STENT, A PERFORATION OCCURRED AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE. IT WAS DETERMINED THAT THERE WAS A CALCIUM NODULE THAT MAY HAVE BEEN IMPACTED THE EXPANSION OF THE STENT. A 4.0X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE GUIDE LINER AND THE SHAFT BROKE. THE SDS WAS SIMPLY REMOVED AND 3.50X19MM GRAFTMASTER WAS IMPLANTED ALONG WITH BALLOON INFLATIONS TO COMPLETE THE PROCEDURE AND SEAL THE PERFORATION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE; HOWEVER, THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 22003588 ↗
• MalfunctionOct 16, 2024Difficult 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 90% DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X33 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY AND THE SDS BECAME STUCK. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS ALSO NOTED. AFTER, REMOVAL, A KINK WAS NOTED APPROXIMATELY 15CM FROM THE TIP OF THE SDS. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER XIENCE STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20466327 ↗
• MalfunctionOct 1, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS NOTED TO HAVE A FLARED STENT WITH A DISLODGEMENT UPON PREPARATION. A 3.5X38 STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT 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 20349031 ↗
• InjuryOct 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, THE STENT DISLODGED IN THE PROXIMAL RIGHT CORONARY ARTERY DUE TO THE CALCIFIED LESION. THE STENT WAS RETRIEVED WITH AN UNSPECIFIED BALLOON, AS THE STENT WAS CLOSE TO THE CATHETER. A NON-ABBOTT DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345716 ↗
• MalfunctionApr 12, 2024Product Quality Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Product Quality Problem; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.50 X 33MM SKYPOINT STENT DELIVERY SYSTEM (SDS) THE STENT SLIPPED OFF THE BALLOON WHILE BEING REMOVED FROM THE HOOP DISPENSER WITH NO RESISTANCE NOTED. THE SDS WAS PREPPED PRIOR TO REMOVING THE PROTECTIVE SHEATH/STYLET. THE PROTECTIVE SHEATH WAS NOTED TO APPEAR 'MELTED', NOT KINKED OR BENT, AND THERE WAS NO DAMAGE NOTED TO THE CHIPBOARD BOX. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER SAME SIZE XIENCE SKYPOINT SDS WAS USED TO COMPETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100206 ↗
• MalfunctionJan 29, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BEFORE USE IN THE PATIENT, THE PROTECTIVE SHEATH OF THE XIENCE SKYPOINT DES 3.50 X 33 RX US WAS DIFFICULT TO REMOVE AND THE STENT SEPARATED FROM THE BALLOON. ANOTHER XIENCE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 18600080 ↗
• InjuryJan 29, 2024Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) ATTEMPTED TO CROSS THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY AND THE SDS WAS REMOVED AND RE-INSERTED. WHILE ATTEMPTING TO CROSS THE TARGET LESION THE GUIDELINER AND GUIDEWIRE MOVED BACK AND THE STENT BECAME DISLODGED. THEREFORE, A SNARE WAS USED TO REMOVE THE DISLODGED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18597205 ↗
• InjuryOct 13, 2023Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT PRESENTED WITH A ST ELEVATION MYOCARDIAL INFARCTION (STEMI). USING RIGHT FEMORAL ACCESS, THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THEREFORE, THE SDS WAS REMOVED AND RESISTANCE WAS ALSO NOTED DUE TO THE ANATOMY. WHEN THE SDS WAS REMOVED, THE STENT WAS NOTED TO HAVE BECOME DISLODGED FROM THE BALLOON. THE GUIDE WIRE (GW) AND GUIDELINER WERE REMOVED; HOWEVER, THE STENT WAS NOT LOCATED ON THE GW OR IN THE GUIDELINER. THE STENT WAS CONFIRMED TO BE NOT BE IN THE CARDIO; HOWEVER, THE STENT WAS NOT ABLE TO BE LOCATED. ANOTHER SAME SIZE XIENCE SKYPOINT STENT WAS IMPLANTED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17934156 ↗
• MalfunctionOct 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE; HOWEVER, WHEN ATTEMPTED TO INFLATE THE DEVICE WOULD NOT GET PASSED 2 ATMOSPHERES. IT WAS REMOVED AND NOTED TO HAVE A PIN WHOLE ON THE BALLOON ITSELF. ANOTHER XIENCE 2.5X33MM WAS USED TO 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 17886740 ↗
• MalfunctionAug 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN OPENING THE CHIPBOARD BOX OF THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THE INSIDE POUCH WAS LABELED AS 3.5X38MM XIENCE SKYPOINT SDS (LOT# 2111541). THEREFORE, THE SDS WAS NOT USED IN A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER XIENCE SKYPOINT STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557948 ↗
• MalfunctionAug 1, 2023Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED THREE TIMES TO NOMINAL PRESSURE TO DEPLOY THE STENT. NEGATIVE PRESSURE WAS THEN APPLIED FOR 15 SECONDS TO DEFLATE THE BALLOON, BUT THE BALLOON WOULD ONLY PARTIALLY DEFLATE. THE SDS WAS REMOVED FROM THE ANATOMY AND THERE WAS STILL DIFFICULTY DEFLATING THE BALLOON. THE STENT WAS DEPLOYED COMPLETELY AND THE PROCEDURE WAS COMPLETED. 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 17432389 ↗
• MalfunctionFeb 24, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED; HOWEVER, THE ACCOUNT STATED THAT THE STENT WAS DISCARDED, SO IT WAS NOT RETURNED WITH THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437145 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.50X33MM XIENCE SKYPOINT WAS IMPLANTED WITHOUT ISSUE. APPROXIMATELY 30 MINUTES POST PROCEDURE THE PATIENT WAS IN RECOVERY AND COMPLAINED OF CHEST PAIN AND ST ELEVATION OCCURRED AND ST ELEVATED MYOCARDIAL INFARCTION (STEMI) WAS DIAGNOSED. THE PATIENT WAS TAKEN BACK TO THE CATH LAB WHERE IT WAS NOTED THE XIENCE SKYPOINT STENT WAS COMPLETELY OCCLUDED WITH THROMBOSIS. A NON-ABBOTT STENT WAS IMPLANTED AND POST DILATATION WAS PERFORMED AS TREATMENT. THE PATIENT WAS STABLE POST INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 15584349 ↗
• MalfunctionJul 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STYLET AND SHEATH OF THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WERE PULLED OFF WITHOUT RESISTANCE. THE SDS WAS GOING TO BE BACKLOADED ONTO THE GUIDE WIRE; HOWEVER, BEFORE LOADING IT WAS NOTED THAT THE STENT WAS NOT ON THE SDS. THE STENT WAS FOUND IN THE SHEATH. THE SDS WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.5X33MM XIENCE SKYPOINT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085980 ↗
• MalfunctionJul 1, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THERE WAS NO STENT WITH THE DEVICE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887330 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT THE NON-TORTUOUS, NON-CALCIFIED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X33 MM XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY, HOWEVER, THE VESSEL WAS TAPERED DISTALLY. DURING POST-DILATATION A DISSECTION WAS NOTED IN THE DISTAL PORTION, POSSIBLY DUE TO THE STENT BEING TOO LARGE FOR THAT PORTION OF THE VESSEL DUE TO THE TAPER. THE DISSECTION WAS COILED AND THE PATIENT WAS PUT ON AN IMPELLA HEART PUMP AND WAS HOSPITALIZED FOR 5 DAYS AND THEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14492024 ↗
• InjuryMay 10, 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 PRESENTED DUE TO EXPERIENCING AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) IN THE RIGHT CORONARY ARTERY (RCA). THREE XIENCE SKYPOINT STENTS WERE IMPLANTED, A 3.50X33MM, 3.50X8MM AND A 4.00X18MM. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED TO TREAT A DIFFERENT VESSEL; HOWEVER, IT WAS NOTED THAT THE THREE STENTS WERE OCCLUDED WITH THROMBUS. THEREFORE, ADDITIONAL STENTS WERE IMPLANTED TO TREAT THE THROMBOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14349963 ↗
• MalfunctionMar 8, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE HEAVILY TORTUOUS VESSEL. RESISTANCE WAS MET DUE TO THE ANATOMY DURING REMOVAL. THERE WERE NO OTHER DEVICE ISSUES NOTED. 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 13693832 ↗
• MalfunctionMar 25, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED DISTAL CIRCUMFLEX ARTERY. AFTER ROTABLATION WAS PERFORMED A 3.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED WITH A NON-ABBOTT GUIDE EXTENSION CATHETER; HOWEVER, FAILED TO CROSS THE LESION DUE TO ANATOMY. DURING REMOVAL OF THE XIENCE SKYPOINT RESISTANCE WAS MET WITH ANATOMY. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11569178 ↗