XIENCE Skypoint™ 1804250-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08717648233098), received between Jan 14, 2021 and Mar 10, 2026 — classified as 13 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 THE 2.5X23MM XIENCE SKYPOINT STENT WAS IMPLANTED IN LEFT ANTERIOR DESCENDING (LAD) ARTERY; HOWEVER, ON (B)(6) 2026 THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION (VF) AND WAS TRANSPORTED TO THE HOSPITAL. AN IMPELLA DEVICE WAS INSERTED. SUBACUTE STENT THROMBOSIS (SAT) WAS NOTED; THEREFORE, BALLOON DILATATION WAS PERFORMED, FOLLOWED BY DRUG-COATED BALLOON (DCB) TREATMENT TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 24559656 ↗
• InjuryFeb 10, 2026Material Rupture; Difficult or Delayed Activation; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% LESION IN LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED; HOWEVER, STENT IMPLANTATION WAS SLOW DUE TO THE DELIVERY SYSTEM BALLOON RUPTURED AT APPROXIMATELY 8 ATMOSPHERES (ATM). THEREFORE, THE STENT DID ACHIEVE ADEQUATE WALL APPOSITION AND AS A RESULT, AN ADDITIONAL BALLOON WAS USED TO COMPLETELY IMPLANT THE STENT. 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 24308615 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) HAD TWO XIENCE SKYPOINT (A 2.5X23MM AND A 2.75X38MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE AND NSTEMI. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 22982320 ↗
• MalfunctionJul 22, 2025Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE ANATOMY. THE DEVICE WAS INFLATED ONCE TO 12 ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED AND THE STENT COULD NOT BE EXPANDED. THE STENT WAS REMOVED ON THE DELIVERY SYSTEM. ANOTHER XIENCE SKYPOINT SDS WAS 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 22568791 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AND THE PROCEDURE WAS TO TREAT THE 100% OCCLUDED LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT EXPERIENCED ANGINA AND WAS EMERGENTLY BROUGHT TO THE CATH LAB AND ACUTE STENT THROMBOSIS WAS DETECTED VIA ANGIOGRAPHY. THREE OTHER XIENCE SKYPOINT STENTS (2.25X15 MM, 3.0X8 MM, 3.25X12 MM) WERE IMPLANTED AND AGGRASTAT WAS PROVIDED. THE PATIENT WAS DISCHARGED OUT OF THE CATH LAB IN STABLE BUT SERIOUS CONDITION AND EXPIRED ON (B)(6) 2024. IN THE PHYSICIAN'S OPINION, NONE OF THE XIENCE SKYPOINT STENTS CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 20747082 ↗
• InjuryApr 16, 2024Material Rupture; Difficult or Delayed Activation; Activation Failure; Material Rupture; Difficult or Delayed Activation; Activation Failure

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS NOTED THAT THE STENT WAS IMPLANTED USING ANOTHER UNSPECIFIED BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116841 ↗
• MalfunctionMar 21, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE AN UNSPECIFIED GUIDE WIRE (GW) WAS IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY AND ANOTHER UNSPECIFIED GW WAS IN THE LEFT CIRCUMFLEX (LCX) CORONARY ARTERY WITH STENTING INTENDED FOR THE LCX. THE 2.5X23 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FELT RESISTANCE ADVANCING OVER THE GW. THE STENT WAS NOTED TO MOVE ON THE BALLOON AND WAS REMOVED FROM THE ANATOMY INTACT. ANOTHER XIENCE SKYPOINT SDS WAS USED TO 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 18953795 ↗
• MalfunctionJan 3, 2024Difficult 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 ANTERIOR DESCENDING (LAD) CORONARY ARTERY THAT WAS BOTH MODERATELY CALCIFIED AND TORTUOUS. THE XIENCE SKYPOINT DES 2.50 X 23 RX STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION IN LAD DUE TO RESISTANCE WITH THE LESION. DURING REMOVAL, THERE WAS RESISTANCE WITH THE LESION. THE DEVICE WAS REPLACED WITH A NON-ABBOTT DEVICE. 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 18439863 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THEN THE 2.5X23 MM XIENCE SKYPOINT STENT WAS DEPLOYED WITHOUT ISSUE. A NON-ABBOTT BALLOON WAS USED FOR POST DILATATION. A PERFORATION WAS NOTED IN THE LAD AND DIAGONAL ARTERIES. TWO ADDITIONAL NON-ABBOTT STENTS WERE PLACED IN THE LAD AND A COIL WAS PLACED IN THE DIAGONAL. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE AND WAS THEN DISCHARGED WHEN THEY RECOVERED. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT IN THE PHYSICIAN'S OPINION, THE XIENCE SKYPOINT STENT DID NOT CAUSE OR CONTRIBUTE TO THE PERFORATION. BASED ON THE ADDITIONAL INFORMATION THIS COMPLAINT WOULD NOT HAVE BEEN REPORTABLE; HOWEVER, SINCE THE INITIAL REPORT HAS ALREADY BEEN FILED, THIS COMPLAINT MUST REMAIN REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 18370161 ↗
• InjuryOct 5, 2023Adverse 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 LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) CORONARY ARTERY WITH HEAVY CALCIFICATION. A 2.50X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A 6F SHEATH AND DEPLOYED SUCCESSFULLY. A 3.25X12 MM TREK BALLOON WAS USED AT 14 ATMOSPHERES FOR 12 SECONDS FOR POST DILATATION AND A DISSECTION WAS NOTED. THE DISSECTION CLOSED ON ITS OWN. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 17882371 ↗
• InjuryJul 24, 2023Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OBTUSE MARGINAL (OM) CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.50X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) STENT WAS DEPLOYED; HOWEVER, THE SDS MET RESISTANCE WITH THE STENT BALLOON DURING REMOVAL; THEREFORE, A 1.5X12MM MINI TREK BALLOON WAS USED TO REMOVED THE SDS. A 2.75X12MM NC TREK NEO BALLOON WAS USED FOR POST DILATATION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378530 ↗
• MalfunctionJul 11, 2023Material 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 NON-CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. THE XIENCE SKYPOINT BALLOON WAS INFLATED TWICE AT 16 ATMOSPHERES FOR 20 SECONDS FOR STENT DEPLOYMENT, BUT THE PRESSURE WAS NOTED TO BE DECREASING. THE DELIVERY SYSTEM WAS REMOVED AND A NON-ABBOTT BALLOON WAS USED TO PERFORM POST-DILATATION PER STANDARD PRACTICE, 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 17302216 ↗
• InjuryApr 18, 2023Improper or Incorrect Procedure or Method; Defective Device; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIRST PROCEDURE WAS PERFORMED ON 01/02/2023 TO TREAT A LESION WITH FOUR XIENCE SKYPOINT STENT DELIVERY SYSTEMS (SDS). A 2.5X23 MM AND 2.25X12 MM XIENCE SKYPOINT STENT WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD), ONE ON THE CIRCUMFLEX (CX), AND THE LAST ONE ON THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS DISCHARGED ON (B)(6) 2023 WITH PLAVEX. ON THE (B)(6) 2023 THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE LAD WAS FOUND TO BE UNDER TOTAL THROMBOTIC OCCLUSION WITH IN STENT RESTENOSIS IN THE OSTIAL,PROXIMAL, MID AND DISTAL LAD WITH 100% STENOSIS. AFTER PRE DILATING THE LESION WITH A 3.25 NON-COMPLIANT BALLOON (NC) TO THE PROXIMAL AND DISTAL STENT IN THE MID LAD AND A 3.00MM NON-COMPLIANT BALLOON (NC) IN THE DISTAL LAD. A 2.75X28 XIENCE SKYPOINT SDS WAS IMPLANTED IN MID LAD, DISTAL TO THE PREVIOUSLY IMPLANTED STENT. REPORTEDLY, THE STENTS WERE UNDERSIZED TO THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 16765488 ↗
• MalfunctionDec 12, 2022Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED, DE NOVO LESION IN THE DISTAL TO PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.0MM NON-ABBOTT BALLOON AND A 2.5MM DEVICE WAS USED TO CRACK THE STENOSIS IN THE LESION. A 2.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, THE DISTAL TIP OF THE DES MET RESISTANCE WITH THE CALCIUM IN THE ANATOMY AND THE DES FAILED TO REACH THE TARGET LESION. THE DES WAS REMOVED, AND IT WAS NOTED THAT THE TIP WAS TORN BUT NOT SEPARATED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 3.0X15MM XIENCE DES WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964938 ↗
• MalfunctionNov 21, 2022Difficult 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, HEAVILY TORTUOUS, 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 2.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED, HOWEVER IT MET RESISTANCE DUE TO THE ANATOMY AND COULD NOT REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY, AND IT WAS NOTED THAT THE STENT EDGE WAS FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 2.25X23MM XIENCE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840895 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID; (B)(6). THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH BIFURCATION, MILD CALCIFICATION, MILD TORTUOSITY AND NO THROMBUS. A 6FR GUIDE CATHETER WAS USED AND THE LESION WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS), THEN THE 3.5X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE AT 16 ATMOSPHERES (ATM) AND POST DILATATION WAS PERFORMED. IN THE 2ND DIAGONAL CORONARY ARTERY, A CUTTING BALLOON WAS USED TO MODIFY THE LESION, A SEMI-COMPLIANT BALLOON WAS USED TO PRE-DILATATION AND THE 2.5X23 MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE, WITH POST-DILATATION. SIDE-BRANCH OCCLUSION OCCURRED DUE TO THE 2.5X23 MM XIENCE SKYPOINT STENT IN THE 2ND DIAGONAL ARTERY AND A MYOCARDIAL INFARCTION OCCURRED; HOWEVER, NO STENT THROMBOSIS WAS NOTED. ANOTHER STENT WAS USED TO BAIL OUT. WHEN THE EVENT OCCURRED, CLOPIDOGREL, ASPIRIN AND DIRECT ORAL ANTICOAGULANT (DOAC) WERE PRESCRIBED. IN POST-PROCEDURE, MODEST ELEVATION OF CREATINE PHOSPHOKINASE (CPK) AND CREATINE KINASE-MB (CK-MB) WAS OBSERVED, BUT ECG CHANGES AND CHEST SYMPTOMS WERE RESOLVED LATER; THEREFORE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. AFTER DISCHARGE F

  Patient problems: Cardiac Enzyme Elevation; Embolism/Embolus; Myocardial Infarction; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 15759910 ↗
• MalfunctionOct 13, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS POSTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.5X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE ANATOMY. RESISTANCE WAS ALSO FELT WITH ANATOMY DURING REMOVAL OF THE DEVICE. A SMALLER XIENCE SKYPOINT 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 15601664 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ON (B)(6) 2022 TWO XIENCE SKYPOINT STENTS (2.5X23MM, 3.0X28MM) WERE IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED FOR CHEST; HOWEVER, NO TREATMENT WAS PROVIDED AND IT WAS NOTED THERE WAS NO ADVERSE PATIENT SEQUELA. PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 15428109 ↗
• MalfunctionJul 25, 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 MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 90% STENOSED. AFTER LESION PRE-DILATATION, THE 2.5X23MM XIENCE SKYPOINT BALLOON EXPANDABLE STENT SYSTEM (BESS) WAS ADVANCED, BUT FAILED TO REACH THE LESION. RESISTANCE WAS NOTED DURING REMOVAL OF THE BESS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100002 ↗
• MalfunctionJun 3, 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 MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED AND TORTUOUS AND 99% STENOSED. THE 2.50 X 23MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED, BUT RESISTANCE WAS MET AND THE DEVICE FAILED TO REACH THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT. AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597489 ↗
• MalfunctionApr 29, 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 MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. THE 2.50 X 23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255827 ↗
• MalfunctionApr 26, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.50X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), DIFFICULTY WAS NOTED WHEN ATTEMPTING TO REMOVE THE STYLET; THEREFORE, THE SDS WAS NOT USED IN THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SAME SIZE XIENCE SKYPOINT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215056 ↗
• MalfunctionFeb 23, 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 LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND FAILED TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588657 ↗
• MalfunctionFeb 8, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). AN UNSPECIFIED STENT WAS PREVIOUSLY IMPLANTED PROXIMAL TO THE TARGET LESION. PRE-DILATATION WAS PERFORMED AND A 2.5X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, THE TIP OF THE DES MET RESISTANCE WITH THE PREVIOUSLY IMPLANTED STENT AND WAS FORCEFULLY PUSHED, CAUSING THE STENT TO BECOME FLARED. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY, 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 13488026 ↗
• MalfunctionNov 7, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LEFT ANTERIOR DESCENDING/ DIAGONAL ARTERY. A 2.5X23MM XIENCE SKYPOINT STENT FAILED TO CROSS DUE TO ANATOMY. THE GUIDE WIRE WAS CHANGED, AND THE STENT DELIVERY SYSTEM WAS RE-INSERTED AND ATTEMPTED AGAIN BUT AGAIN FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, THE DEVICE ALSO MET RESISTANCE WITH ANATOMY. THE PROCEDURE FINISHED AS IS WITHOUT FURTHER INTERVENTION PERFORMED. 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 12763319 ↗