XIENCE Skypoint™ 1804350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 08717648233449), received between Jan 29, 2021 and Jul 6, 2026 — classified as 2 deaths, 17 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Break; Improper or Incorrect Procedure or Method; Defective Device; Material Deformation; Activation Failure; Noise, Audible; Migration; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, MILDLY CALCIFIED, MILDLY TORTUOUS MID-RIGHT CORONARY ARTERY LESION WITH 50% STENOSIS. A 3.5X38 MM XIENCE SKYPOINT DRUG-ELUDING STENT (DES) WAS ADVANCED TO THE TARGET LESION. HOWEVER, A SCRAPING/GRINDING SOUND WAS HEARD. THE STENT WAS REMOVED AND INSPECTED, BUT NO DAMAGE WAS NOTED. THE STENT WAS ADVANCED TO THE TARGET LESION AGAIN. DURING INFLATION AT 6 ATM, ONLY THE DISTAL PORTION OF THE BALLOON INFLATED DUE TO A CRACK IN THE SHAFT. THEREFORE, THE STENT WAS PARTIALLY DEPLOYED, AND THE BALLOON WAS UNABLE TO BE DEFLATED. THE DELIVERY SYSTEM WAS SLOWLY REMOVED AND THE STENT MOVED BACK TO THE PROXIMAL SECTION OF THE LESION. THE DELIVERY SYSTEM WAS REMOVED, BUT THE STENT REMAINED IN THE ANATOMY AND HAD SHORTENED TO 30 MM. A 4 MM BALLOON DILATION CATHETER WAS USED TO FULLY DEPLOY THE STENT. THE STENT WAS DEPLOYED IN PART OF THE LESION SITE AND A HEALTHY SEGMENT, AND THE STENT STRUTS APPEARED TO BE OVERLAPPED IN TWO LAYERS. A NEW 4X23 MM XIENCE DES 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 25722677 ↗
• MalfunctionOct 15, 2025Component Missing; Device Dislodged or Dislocated; Component Missing; Device Dislodged or Dislocated

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, RETURN DEVICE ANALYSIS FOUND THAT THERE WERE VISIBLE CRIMP MARKS ON THE BALLOON WHERE THE STENT WAS INITIALLY CRIMPED, INDICATING THAT THE STENT HAD DISLODGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293009 ↗
• DeathApr 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5 X 38 MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS SUCCESSFULLY IMPLANTED AT THE LESION; HOWEVER, DURING POST DILATATION, WITH DELIVERY CATHETER OF THE IMPLANTED XIENCE SKYPOINT, AT 17 ATMS [ABOVE RATED BURST PRESSURE (RBP)] A PERFORATION WAS NOTED. REMEDIAL ACTIONS WERE ATTEMPTED; HOWEVER, THE PATIENT WAS NOTED TO EXPIRE. PER THE PHYSICIAN'S OPINION, THE DEATH WAS NOT DUE TO THE USE OF THE XIENCE SKYPOINT NOR POST-DILATATION WITH THE DELIVERY CATHETER AND WAS DEEMED TO BE CAUSED BY USER ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 21867303 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX) ARTERIES. A 3.50X48MM AND A 3.50X38MM XIENCE SKYPOINT STENTS WERE IMPLANTED WITHOUT ISSUE. AT THE END THE PROCEDURE, THE PATIENT WAS AWAKE, ALERT, AND IN RECOVERY WITH FAMILY. HOWEVER, LATER THAT DAY THE PATIENT CODED AND WAS BROUGHT BACK TO THE CATH LAB WHERE ANGIOGRAPHY SHOWED THROMBUS IN THE LEFT MAIN (LM). A GUIDE WIRE WAS PLACED AND THROMBECTOMY WAS ATTEMPTED HOWEVER THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 21677039 ↗
• InjuryJan 28, 2025Difficult 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 THE LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. MULTIPLE STENTS WERE PLACED AND A DISSECTION WAS NOTED DUE TO THE GUIDE CATHETER. THE VESSEL THE 3.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED THROUGH THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THERE WAS RESISTANCE, AND THE STENT DISLODGED. THE DELIVERY SYSTEM HUNG ON THE RADIAL SHEATH DURING REMOVAL. A SNARE WAS USED TO REMOVE THE STENT AND RADIAL SHEATH. THE DISTAL LIMA GRAFT AND LAD HAD NO REFLOW DUE TO THE DISSECTION FROM THE GUIDE CATHETER. THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE AND THEY WERE STABLE. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257069 ↗
• MalfunctionJan 22, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY WITH SEVERE CALCIFICATION. THE 3.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED BUT MET RESISTANCE WITH THE GUIDE CATHETER EXTENSION. THE SDS WAS REMOVED; HOWEVER IT WAS FOUND THAT THE STENT WAS NOT ON THE DEVICE BUT ON THE COPILOT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210786 ↗
• MalfunctionDec 9, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS MET WITH RESISTANCE WITH THE GUIDE CATHETER AND THE STENT BECAME DEFORMED AND DISPLACED ON THE BALLOON. THE STENT WAS REMOVED VIA A FEMORAL APPROACH. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. 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 20884554 ↗
• InjuryNov 12, 2024Difficult 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 THE LEFT MAIN, LEFT ANTERIOR DESCENDING, CIRCUMFLEX AND BIFURCATION WITH HEAVY CALCIFICATION. THE 4.0X23MM XIENCE SKYPOINT WAS ATTEMPTED TO ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. UPON REMOVAL THE STENT WAS OBSERVED TO BE FLARED. A 3.5X38MM XIENCE SKYPOINT WAS ADVANCED BUT FAILED TO CROSS DUE TO ANATOMY AND THE STENT STRUT WAS NOTED TO BE FLARED. ANOTHER 3.5X38MM XIENCE SKYPOINT MET RESISTANCE WITH ANATOMY AND FAILED TO CROSS. DURING REMOVAL RESISTANCE WAS FELT WITH ANATOMY AND THE STENT DISLODGED. THE STENT WAS REMOVED VIA SNARE. A 3.0X16MM AND 3.5X33MM XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 20663531 ↗
• InjuryOct 30, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) ATTEMPTED TO CROSS THE TARGET LESION; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY. THE DISTAL EDGE OF STENT LOOKED DAMAGED AND A DISSECTION WAS NOTED. THEREFORE, A SHOCKWAVE THERAPY AND BALLOONING FOLLOWED BY IMPLANTATION OF A 3X38MM XIENCE SKYPOINT STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 20570875 ↗
• InjurySep 30, 2024Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress; Improper or Incorrect Procedure or Method; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PRE-DILATATION WITH A NON-ABBOTT DEVICE THE 3.5X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE CALCIFICATION. THE DES WAS REMOVED AND REINSERTED AFTER ADDITIONAL DILATATION WAS PERFORMED BUT WAS UNABLE TO CROSS THE LESION AND A BEND WAS NOTED IN THE SHAFT. AFTER THE SECOND REMOVAL A SEVERE PERFORATION WAS NOTED, AND TWO NON-ABBOTT STENTS WERE DEPLOYED TO TREAT THE PERFORATION. A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 20334109 ↗
• MalfunctionAug 30, 2024Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED VESSEL. THE 3.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPARED FOR USE AND THE STYLET FELT STIFF DURING REMOVAL. STENT DAMAGE WAS NOTED; THE STENT APPEARED TO BE BENT OR CRUSHED. HOWEVER, THE SDS WAS USED. THE SDS WAS ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS THEN NOTED TO BE MISSING. THE DEVICE AND GUIDE CATHETER WERE REMOVED. THE STENT WAS THEN LOCATED OUTSIDE THE ANATOMY, ON TOP OF THE PACKAGING IN THE TRASH. ANOTHER UNSPECIFIED SDS WAS USED. 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 20107378 ↗
• MalfunctionApr 3, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT RADIAL ARTERY. THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS NEGATIVELY PREPARED AND FAILED TO FOLLOW PREPARATION PROCEDURE PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH AND THERE WAS NO FORCE APPLIED. UPON INSERTING THE SDS ONTO THE 6FRENCH (F) GUIDING CATHETER, IT WAS NOTED THAT THE STENT WAS MISSING. THE STENT WAS FOUND AND NOTED TO BE HALF IN AND HALF OUT OF THE PROTECTIVE SHEATH. ANOTHER XIENCE SKYPOINT 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 19037911 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CORONARY ANGIOPLASTY WAS PERFORMED VIA ACCESS IN THE RIGHT FEMORAL ARTERY WITH A 4F SHEATH TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) WITH MODERATE TORTUOSITY, SLIGHT CALCIFICATION AND 80% STENOSIS. A NON-ABBOTT GUIDE CATHETER WERE ADVANCED TO THE LEFT MAIN CORONARY ARTERY AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE DISTAL LAD. PRE-DILATION WAS PERFORMED WITH A 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) INFLATED TO 8 ATMOSPHERES (ATM) X 10 SECONDS, 10 ATM X 10 SECONDS, AND 10 ATM X 10 SECONDS, THEN REMOVED. THE 3.5X38MM XIENCE SKYPOINT WAS IMPLANTED AT THE PROXIMAL LAD AT 12 ATM FOR 10 SECONDS WITHOUT DIFFICULTY. THE 4F SHEATH WAS EXCHANGED FOR A 6F SHEATH AND AN NON-ABBOTT INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS INSERTED. A PULLBACK WAS PERFORMED AND THE IVUS CATHETER WAS REMOVED. POST DILATION WAS PERFORMED WITH A 3.75X15MM NC TREK NEO BDC INFLATED TO 16 ATM X 10 SECONDS, 18 ATM X 10 SECONDS, 18 ATM X 10 SECONDS AND 18 ATM X 10 SECONDS THEN REMOVED. AN ANGIOGRAM WAS THEN PERFORMED, NOTING A PERFORATION. THE NC TREK NEO BDC WAS RE-INSERTED TO THE PERFORATION SITE AND INFLATED TO 12 ATM FOR 20 SECONDS. THE PATIENT BEGAN TO DECOMPENSAT

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion; Tachycardia

  MAUDE report 18712475 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO USE, WHEN REMOVING THE 3.50X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FROM THE HOOP DISPENSER, THE STENT CAME OFF THE DELIVERY CATHETER. NO RESISTANCE WAS NOTED DURING REMOVAL AND THERE WAS NO DAMAGE TO THE CHIPBOARD BOX OR THE HOOP DISPENSER. THERE WAS NO MANIPULATION OF THE STENT AND NO ATTEMPT TO REMOVE THE STYLET AND/OR THE PROTECTIVE SHEATH. THE SDS WAS NOT USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER XIENCE SKYPOINT SDS. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552800 ↗
• MalfunctionDec 26, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5 X 38 XIENCE SKYPOINT STENT FAILED TO CROSS THE LESION DUE TO PATIENT ANATOMY. RESISTANCE WAS NOTED WITH THE LESION UPON REMOVAL. 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 18393525 ↗
• MalfunctionDec 12, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER PREPARATION OF THE 3.50 X 38 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THE PROTECTIVE SHEATH WAS REMOVED AND THE STENT CAME OFF [DISLODGED] AND REMAINED ON THE STYLET. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SKYPOINT SDS. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312135 ↗
• MalfunctionNov 17, 2023Leak/Splash; Improper or Incorrect Procedure or Method; Leak/Splash; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED AND MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND ONCE AT THE LESION SITE, THE DEVICE WAS ASPIRATED. AFTER ASPIRATION BLOOD WAS OBSERVED IN THE UNSPECIFIED INFLATION DEVICE [LEAK]. AS A RESULT, THE SDS WAS REMOVED WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159899 ↗
• InjuryNov 3, 2023Difficult to Remove; Device Damaged by Another Device; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LAD. TWO 3.5X38MM AND 2.75X38MM XIENCE SKYPOINT STENTS WERE IMPLANTED. DURING REMOVAL OF UNSPECIFIED GUIDE WIRE IT WAS NOTED TO HAVE MET RESISTANCE WITH THE PROXIMAL 3.5X38MM XIENCE SKYPOINT STENT; HOWEVER, NO OTHER COMPLICATIONS WERE NOTED OR ISSUES. ABOUT 30 MINUTES LATER THE PATIENT SUFFERED AN MYOCARDIAL INFRACTION (MI) AND IT WAS CONFIRMED VIA ANGIOGRAM THAT THROMBUS WAS PRESENT ONLY ON THE PROXIMAL XIENCE SKYPOINT STENT NOT ON THE DISTAL XIENCE SKYPOINT STENT THAT WAS IMPLANTED. ANGIOPLASTY WAS PERFORMED TO TREAT THE THROMBUS AND MEDICATION WAS GIVEN TO TREAT THE MI. IT WAS NOTED THAT PROXIMAL STENT MIGHT HAVE BECOME FLARED WHEN IT MET RESISTANCE WITH THE UNSPECIFIED GUIDEWIRE DURING THE ORIGINAL PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 18067102 ↗
• InjuryOct 30, 2023Break; Leak/Splash; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Break; Leak/Splash; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, NO TORTUOSITY AND 80% STENOSIS. THE 3.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. WHEN THE TECH PULLED NEGATIVE ON THE DEVICE AND THEN TRIED TO INFLATE THE DEVICE, CONTRAST BEGAN TO SPRAY OUT OF A CRACK IN THE HUB OF THE DEVICE. NEGATIVE PRESSURE WAS PULLED AGAIN AND THE SDS WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE STENT DISLODGED FROM THE BALLOON. A 2.0 MM BALLOON WAS THEN ADVANCED AND USED TO TRY AND PULL THE STENT BACK INTO THE GUIDING CATHETER. THE STENT BECAME CAUGHT ON THE MODERATE PROXIMAL DISEASE IN THE VESSEL. THE BALLOON WAS INFLATED IN THE DISTAL PART OF THE STENT AND SINCE THE STENT WAS NOW PARTIALLY DEPLOYED AND THERE WAS DISEASE IN THE PROXIMAL VESSEL, THE BALLOON WAS USED TO DEPLOY THE STENT WHERE IT WAS LOCATED AND POST-DILATED WITH A 4.5 MM BALLOON TO MATCH THE INTRAVASCULAR ULTRASOUND (IVUS) SIZING OF THE VESSEL. THE STENT IS LOCATED COMPLETELY OUTSIDE THE TARGET LESION; HOWEVER, THE AREA IS DISEASED. A NEW 38 MM STENT WAS IMPLANTED DISTALLY TO THE ORIGINAL LESION AND WAS CONNECTED TO THE PROXIMAL STEN

  Patient problems: Foreign Body In Patient

  MAUDE report 18029867 ↗
• MalfunctionOct 17, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT IS 100% STENOSED. THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY. WHEN REMOVING THE SDS RESISTANCE WAS MET WITH THE GUIDE CATHETER AND THE STENT DISLODGED. THE GUIDE CATHETER WAS REMOVED AND THE STENT WAS NOTED TO BE INSIDE THE GUIDE CATHETER. ANOTHER DEVICE 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 17949967 ↗
• InjuryOct 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RECEIVED MEDWATCH MW5145131 WHICH STATES: STENT FELL OFF DELIVERY BALLOON DURING IMPLANT AND IT NEEDED SNARED OUT OF HER LAD/LM(LEFT ANTERIOR DESCENDING ARTERY/LEFT MAIN ARTERY). THERE WAS A PROLONGED EPISODE RESUSCITATION WITH MULTIPLE SHOCKS AND ENDOTRACHEAL INTUBATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Respiratory Failure

  MAUDE report 17931120 ↗
• MalfunctionSep 15, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE PATIENT WAS BEING URGENTLY TREATED FOR A ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI); THEREFORE, THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS OPENED AND PUT STRAIGHT INTO THE PATIENT¿S BODY WITHOUT PREPPING. THE SDS WAS ADVANCED AND DEPLOYED; HOWEVER, ONCE THE SDS WAS REMOVED AND ANGIOGRAPHY WAS PERFORMED IT WAS NOTED THAT THERE WAS NO STENT AT THE DEPLOYMENT SITE. THE VESSEL LOOKED AS IF IT HAD JUST BEEN BALLOONED. POST-PROCEDURE THE STENT WAS FOUND ON THE STYLET AND PARTIALLY IN THE PROTECTIVE SHEATH. IT WAS REPORTED THAT THE TECH WAS REMOVING THE PROTECTIVE SHEATH AND STYLET BUT, PINCHED TOO HARD AND THE STENT CAME OFF WITH IT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF A NEW 3.5X38MM XIENCE SKYPOINT STENT. 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 17757647 ↗
• MalfunctionAug 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED THROUGH THE GUIDE CATHETER; HOWEVER, IT WAS NOTED THAT THE STENT BECAME DISLODGED IN THE GUIDE CATHETER. THE DEVICES WERE REMOVED WITHOUT ISSUE. ANOTHER UNSPECIFIED GUIDE CATHETER AND A 3.5X38MM XIENCE SKYPOINT STENT WERE 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 17588274 ↗
• MalfunctionJul 7, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.50X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE THE ANATOMY AND THE PROCEDURE WAS END WITHOUT TREATMENT. THERE WAS RESISTANCE NOTED WITH THE LESION DURING REMOVAL. 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 17278899 ↗
• InjuryJun 1, 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 MILDLY CALCIFIED, 95% STENOSED LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD), RIGHT CORONARY (RCA) AND DIAGONAL (LEFT CORONARY) ARTERIES. ON (B)(6) 2023, THE PATIENT HAD 7 XIENCE SKYPOINT DRUG ELUTING STENTS (DES) IMPLANTED WITHOUT ISSUE. A 4.5X33MM AND 4.5X18MM STENTS WERE PLACED IN THE RCA. A 3.0X38MM, 3.5X38MM AND 3.5X8MM STENTS WERE PLACED IN THE LAD. A 2.5X18MM AND 2.5X8MM STENTS WERE PLACED IN THE DIAGONAL ARTERY. ON (B)(6)2023, THE PATIENT PRESENTED TO A DIFFERENT PHYSICIAN EXPERIENCING CONSTANT ARRHYTHMIAS THROUGHOUT THE DAY AND BRADYCARDIA WITH HEART RATES OF 32-35 BEATS PER MINUTE (BPM). THE PATIENT WAS ASYMPTOMATIC PRIOR TO HIS PROCEDURE ON 3/24/2023. ADDITIONAL TREATMENT HAS NOT YET BEEN PROVIDED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 17035767 ↗