XIENCE Skypoint™ 1804250-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08717648233074), received between Jan 13, 2021 and Mar 24, 2026 — classified as 18 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (18 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE OBTUSE MARGINAL ARTERY WITH MODERATE CALCIFICATION. THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, AND THE STENT WAS ATTEMPTED TO BE DEPLOYED. HOWEVER, THE BALLOON FAILED TO INFLATE, AND THE DEVICE WAS NOTED TO NOT BE HOLDING PRESSURE. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT. ANOTHER XIENCE SKYPOINT SDS WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24675526 ↗
• MalfunctionNov 26, 2025Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF A 2.50X15MM XIENCE SKYPOINT DRUG-ELUTING STENT, THE HOOP DISPENSER AND PROXIMAL SHAFT WERE NOTED TO BE KINKED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THE HYPOTUBE WAS KINKED AND SEPARATED DISTAL TO THE STRAIN RELIEF TUBING. THE HYPOTUBE FRACTURE FACES WERE OVAL SHAPED AND THE MATERIAL AT THE NOTED SEPARATIONS WERE JAGGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23661073 ↗
• MalfunctionJun 25, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE RAMUS BRANCH. AFTER DEPLOYING A 2.5X15MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) IT WAS NOTED THAT THE BALLOON ON THE DELIVERY CATHETER COULD NOT BE FULLY DEFLATED WHEN NEGATIVE PRESSURE WAS APPLIED FOR 30SEC. CAUSING RESISTANCE DURING WITHDRAWAL ATTEMPTS. FOLLOWING MULTIPLE ATTEMPTS TO DEFLATE THE BALLOON WITH AN INDELFATOR, THE BALLOON WAS ULTIMATELY FULLY DEFLATED WITH ANOTHER SYRINGE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22332254 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT (B)(6) 2022 THE PATIENT UNDERWENT STENTING IN THE LEFT MAIN CORONARY ARTERY WITH A 4.5X12 MM XIENCE SKYPOINT STENT AND IN THE FIRST OBTUSE MARGINAL (OM1) CORONARY ARTERY WITH A 2.5X15 MM XIENCE SKYPOINT STENT (LOT 1100541). THE PATIENT WAS ON CLOPIDOGREL UNTIL (B)(6) 2023 WHEN THE PRESCRIPTION RAN OUT NEEDED TO BE REQUESTED AGAIN. THE PATIENT RESTARTED CLOPIDOGREL MEDICATION ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT HAD AN ANNUAL FOLLOW UP VISIT WITH THE CARDIOLOGIST AFTER SHE HAD A RECENT HYPOTENSIVE SYNCOPAL EPISODE DUE TO METOPROLOL. DURING THE VISIT THERE WERE NO PRESENT SYMPTOMS, BUT BECAUSE OF HER HISTORY OF SEVERE CORONARY ARTERY DISEASE, A STRESS TEST WAS RECOMMENDED. THE PATIENT HAD AN ABNORMAL STRESS TEST ON (B)(6) 2024 AND WAS SUBSEQUENTLY SCHEDULED FOR A HEART CATHETERIZATION. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2024. HEART CATHETERIZATION FOUND THE PATIENT HAD 80% IN-STENT RESTENOSIS IN THE OM1. REVASCULARIZATION (BALLOON ANGIOPLASTY AND ANGIOSCULPT) WAS ONLY PERFORMED IN THE OBTUSE MARGINAL CORONARY ARTERY ON (B)(6) 2024 AND THE CONDITION RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELAE. THE PATIENT WAS DISCH

  Patient problems: Stenosis

  MAUDE report 21152065 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) HAD THREE XIENCE SKYPOINT (2.5X15, 2.5X38, 3.5X33MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2024 WITH CHRONIC ISCHEMIC HEART DISEASE AND NSTEMI. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED IN AN UNSPECIFIED VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 21061983 ↗
• InjurySep 20, 2024Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 2.5X15MM XIENCE SKYPOINT STENT DISLODGED. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. ADDITIONALLY, A PHOTO WAS RECEIVED THAT SHOWS THAT BALLOON APPEARS TO BE INFLATED AND THE STENT WAS NOT RETURNED. IT IS UNKNOWN IF THE STENT REMAINS IN THE PATIENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20271920 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI), HAD THREE XIENCE SKYPOINT (2.5X15, 2.5X23, 3.0X23MM) STENTS IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND NSTEMI. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 19924569 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREPARED USING BALLOON DILATATION. THE 2.5X15MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING INFLATION THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE SDS WAS REMOVED WITH THE STENT STILL MOUNTED ON THE BALLOON. THE LESION WAS PRE-DILATED AGAIN AND A 2.25X15MM SKYPOINT WAS IMPLANTED. 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 19358102 ↗
• 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 HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY. THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY AND INTERACTION WITH A PREVIOUSLY IMPLANTED STENT. THE STENT DISLODGED AND A BALLOON DILATATION CATHETER WAS INFLATED AND DEPLOY THE STENT INSIDE OF THE PREVIOUSLY IMPLANTED STENT. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18869104 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. A 2.5X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED MID-DISTAL AND THEN A 3.0X28MM XIENCE SKYPOINT WAS IMPLANTED PROXIMAL-MID WITH A SLIGHT OVERLAP. THE STENTS WERE POST-DILATED. THERE WAS SIGNIFICANT TISSUE PROTRUSION [PROLPASE] AT THE PROXIMAL PORTION OF THE 2.5X33MM XIENCE SKYPOINT STENT JUST DISTAL TO THE OVERLAP. IT WAS STENTED OVER WITH 2.5X15MM XIENCE SKYPOINT STENT. THE PROCEDURE WAS FINISHED AT WHICH POINT THE PATIENT STARTED HAVING CHEST PAIN. THE PATIENT WAS RE-ACCESSED AND IT WAS NOTED THAT THE 2.5X15MM STENT THROMBOSED AT THE POINT OF TISSUE PROTRUSION. STENTS WERE POST-DILATED AGAIN. ADDITIONALLY, PROXIMAL CALCIUM AT THE OSTIAL LAD WAS TREATED WITH SHOCKWAVE AND THEN STENTED OVER WITH A 3.5X18MM XIENCE SKYPOINT STENT. PROCEDURE WAS FINISHED. PATIENT WAS REMOVED OFF THE TABLE AND STARTED HAVING CHEST PAINS AGAIN AND WENT INTO VENTRICULAR FIBRILLATION, WHICH WAS TREATED WITH DEFIBRILLATION. PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE HAD TWO MORE EPISODES OF CHEST PAIN AND DEFIBRILLATION. PATIENT WAS ULTIMATELY SUCCESSFULLY DISCHARGED.

  Patient problems: Angina; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 18328754 ↗
• MalfunctionNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION AND HEAVY TORTUOSITY. THE 2.5X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE AND FLUOROSCOPY SHOWED THAT THE STENT HAD MOVED PROXIMALLY ON THE BALLOON. THE SDS WAS REMOVED AND IT WAS CONFIRMED THAT THE STENT HAD SHIFTED BUT REMAINED ON THE BALLOON. A NEW 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 18144444 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PROCEDURE WAS TO TREAT A LESION IN THE SECOND DIAGONAL CORONARY ARTERY. THE LESION WAS 10-20 MM, AFFERENT, WITH MILD TORTUOSITY AND NO CALCIFICATION. AFTER OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THE LESION, PRE-DILATATION WAS PERFORMED WITH A SEMI-COMPLIANT BALLOON AND A 2.5X15 MM XIENCE SKYPOINT STENT WAS IMPLANTED, FOLLOWED BY POST-DILATATION. THE STENT IMPLANTATION WAS SUCCESSFUL. WHEN THE PATIENT WAS SEEN FOR TWELVE MONTH FOLLOW-UP, THERE WERE NO ABNORMALITIES NOTED. ON (B)(6) 2022, THE PATIENT HAD CHEST PAIN AND UPON EXAMINATION THERE WAS IN-STENT RESTENOSIS (ISR) IN THE SECOND DIAGONAL ARTERY. REVASCULARIZATION WAS PERFORMED WITH A DRUG COATED BALLOON. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY AND AT THE TIME OF THE EVENT, PRASUGREL WAS RESUMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 17961968 ↗
• MalfunctionSep 15, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A NON-CALCIFIED OR TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.50X15MM RX XIENCE SKYPOINT DRUG ELUTING STENT (DES) SYSTEM WAS ADVANCED TO THE TARGET LESION HOWEVER THE BALLOON WOULD NOT INFLATE. THE CONNECTION TO THE INFLATOR WAS CHECKED AGAIN AND STILL THE BALLOON WOULD NOT INFLATE. THE DES WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE COMPLETED USING ANOTHER DES. 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 17760938 ↗
• InjurySep 13, 2023Unintended System Motion; Material Rupture; Unintended System Motion; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD). PRE-DILATATION WAS PERFORMED. THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPPED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. THE SDS WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 3 OR 4 ATMOSPHERES. THE STENT WAS NOTED AS NOT SUFFICIENTLY DEPLOYED DUE TO THE BALLOON RUPTURE. THEREFORE, THE SDS WAS REMOVED AND A NON-ABBOTT BALLOON WAS USED TO FULLY DEPLOY THE XIENCE SKYPOINT STENT. DURING DEPLOYMENT THE STENT BECAME DISPLACED ABOUT 2MM FROM THE INTENDED IMPLANT POSITION; HOWEVER, THE STENT WAS IMPLANTED IN THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740769 ↗
• MalfunctionJun 1, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION OF A 2.50X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES), THE SEALED AND UNDAMAGED CHIPBOARD BOX OF THE DES WAS OPENED FOR USE WHEN IT WAS NOTED THAT THE INNER FOIL PACKAGE HAD A TEAR IN IT. STERILITY WAS UNKNOWN, THEREFORE THE DEVICE WAS DISCARDED AND NOT USED IN THE PATIENT. A NEW SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042961 ↗
• InjuryMar 28, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY. THE 2.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS MET WITH RESISTANCE DUE TO THE ANATOMY AND THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. A 1.50MM BALLOON WAS USED TO PULL BACK THE STENT AND THE STENT WAS DEPLOYED IN THE OSTIAL LAD. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16631805 ↗
• InjuryJan 4, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; 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 PROXIMAL OSTIAL CIRCUMFLEX WITH MILD CALCIFICATION, HEAVY TORTUOSITY AND 90 DEGREE ANGLE. THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE 90-DEGREE ANGLE. THE SDS WAS REMOVED AND THE STENT WAS CHECKED. A 6 FRENCH (FR) GUIDELINER WAS ADVANCED AND THE SDS WAS RE-ADVANCED; HOWEVER, AGAIN THE SDS WOULD NOT ADVANCE PAST THE TURN (90-DEGREE ANGLE). A LOT OF RESISTANCE WITH THE GUIDELINER WAS FELT DURING REMOVAL, HOWEVER, THE SDS WAS REMOVED AS A SINGLE UNIT. THE SDS WAS YANKED OUT AND THE STENT DISLODGED. THE LEFT VENTRICLE WAS CHECKED BUT THE STENT WAS NOT THERE AND INSTEAD FOUND TO BE IN THE DESCENDING AORTA. A SNARE WAS USED TO SUCCESSFULLY REMOVE THE DISLODGED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097050 ↗
• InjuryNov 28, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90%STENOSED DE NOVO LESION IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. A 2.50X15MM NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION. THEN, THE 2.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED BE ADVANCED TO THE TARGET LESION; HOWEVER FAILED TO CROSS DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE ANATOMY. HOWEVER, DURING REMOVAL THE STENT BECAME DISLODGED FROM THE BALLOON IN THE LCX TO THE LEFT MAIN TRUNK ARTERY. THE STENT WAS ATTEMPTED TO BE REMOVED WITH THE GUIDEWIRE (GW), BUT THE STENT WAS NOT ABLE TO BE REMOVED; THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE STENT. THIS ENDED THE PROCEDURE AND NO ADDITIONAL TREATMENT WAS PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870198 ↗
• MalfunctionSep 20, 2022Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE OF THE 2.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THE PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE. THE CATHETER WAS SOAKED IN SALINE AND THE DEVICE WAS PREPPED (AIR ASPIRATION) INSIDE THE ANATOMY. THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE DISTAL LEFT CIRCUMFLEX ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE SDS WAS ADVANCED TO THE TARGET LESION WITH DIFFICULTY DUE TO THE ANATOMY. HOWEVER, THE BALLOON BURST DURING THE FIRST INFLATION AFTER 20 SECONDS AT 12 ATMOSPHERES (ATM). THE SDS WAS REMOVED FROM THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459785 ↗
• MalfunctionAug 26, 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 LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE SDS DID NOT CROSS DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT WITH DIFFICULTY DUE TO ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307502 ↗
• MalfunctionAug 23, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MILDLY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED. THE XIENCE SKYPOINT WAS ADVANCED, BUT MET RESISTANCE AND DID NOT CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS MET. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280167 ↗
• InjuryAug 11, 2022Material Protrusion/Extrusion

  WIRE WAS ADDED FOR SUPPORT TO ADVANCE THE STENT. WHEN THE STENT WAS NEEDED TO REINSERT, IT WAS NOTED TO HAVE A STENT STRUT PROTRUDING OUT OF THE STENT. THE STENT DID NOT REENTER THE BODY AND WAS REMOVED FROM THE FIELD AND A NEW STENT WAS OBTAINED. NO APPARENT SIDE AFFECTS WERE NOTED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216893 ↗
• InjuryJun 29, 2022Improper 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 LOCATED IN THE OSTIAL LEFT CIRCUMFLEX ARTERY (LCX) THAT WAS MODERATELY CALCIFIED AND TORTUOUS. AFTER LESION PRE-DILATATION, THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED BUT FAILED TO REACH THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED, SO FORCE WAS APPLIED AND THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. THE DISLODGED STENT WAS SUCCESSFULLY SNARED AND REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14863549 ↗
• InjuryJun 22, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS RIGHT CORONARY ARTERY. THREE XIENCE SKYPOINT STENT DELIVERY SYSTEMS (2.5X15MM, 2.5X12MM, AND 2.5X08MM) FAILED TO CROSS THE LESION; HOWEVER, A DISSECTION WAS NOTED. IT IS UNKNOWN IF THERE WAS ANY TREATMENT PROVIDED FOR THE DISSECTION. AN UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14775993 ↗
• MalfunctionMay 26, 2022Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID CIRCUMFLEX ARTERY. THE 2.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS LOADED ONTO AN UNKNOWN GUIDE WIRE; HOWEVER, THE SDS FROZE ON THE GUIDE WIRE BEFORE REACHING THE PATIENT ANATOMY. SINCE THE SDS WOULD NOT ADVANCE ON THE GUIDE WIRE AN ATTEMPT TO REMOVE THE SDS WAS MADE, BUT IT WAS STUCK. FORCE WAS APPLIED TO REMOVE IT AND THE DISTAL SHAFT SEPARATED. THE DISTAL SHAFT WAS REMOVED FROM THE GUIDE WIRE WITH FORCE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME GUIDE WIRE AND A NEW 2.5X15MM XIENCE SKYPOINT STENT. 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 14516186 ↗