XIENCE Skypoint™ 1804350-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08717648233395), received between Apr 19, 2021 and Jul 28, 2026 — classified as 1 death, 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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 33 reports, in the reporter's own words as published by the FDA.

• DeathJul 28, 2026Off-Label Use; Adverse Event Without Identified Device or Use Problem

  It was reported that the procedure was to treat a basilar artery. The lesion was pre-dilated with a 2.75 x 10mm Sapphire II PRO balloon. The 3.50 x 15mm Xience Skypoint drug-eluting stent was implanted when suspected hyper fusion syndrome occurred. Post dilatation was not performed, and it was noted that hemostasis was achieved with a ProStyle device. Subsequently, the patient was transferred to the intensive care unit for observation when left hand immobility, and right pupil dilation and right sided blindness were noted. A code blue was called, and it was determined that the patient was experiencing a right sided cerebral hemorrhage. The patient was stabilized and another code blue was called. Medication was provided and the patient transferred to another center for potential further intervention. Following the patient's transfer to another facility, no additional information from that facility is available. It was subsequently noted on (b)(6) 2026 that the patient died on (b)(6) 2026. No additional information was provided.

  Patient problems: Dyskinesia; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Nervous System Injury; Visual Disturbances

  MAUDE report 50060973 ↗
• MalfunctionJun 3, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WHEN THE DEVICE HAD RESISTANCE WITH A NON-ABBOTT HEMOSTATIC ROTATING HEMOSTATIC VALVE (RHV) AND THE STENT CAME OFF INSIDE THE RHV. THE DISLODGED STENT WAS SIMPLY REMOVED FROM THE RHV AND 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 25376976 ↗
• MalfunctionDec 16, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.50X15MM RX XIENCE SKYPOINT, WHEN REMOVED FROM THE CHIPBOARD BOX, IT WAS NOTED THE FOIL POUCH WAS ALREADY OPEN. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. 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 23817399 ↗
• MalfunctionJun 9, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED INTO A 5F GUIDE EXTENSION CATHETER; HOWEVER, THE SDS BECAME STUCK WITH THE EXTENSION GUIDE CATHETER. THEREFORE, THE SDS AND GUIDE CATHETER HAD TO BE REMOVED AS A SINGLE UNIT. A 6F EXTENSION GUIDE CATHETER AND ANOTHER SAME SIZE XIENCE SDS WERE USED TO CONTINUE 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 22170228 ↗
• MalfunctionFeb 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. ABLATION AND PRE-DILATATION WAS PERFORMED. THE 3.50X15MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES. THE SDS INCLUDING THE STENT WERE REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT 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 21355099 ↗
• MalfunctionJul 10, 2024Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 3.50X15MM XIENCE SKYPOINT DRUG ELUTING STENT TO THE MID LEFT ANTERIOR DESCENDING ARTERY, THE STENT DELIVERY SYSTEM (SDS) INTERACTED WITH THE GUIDE CATHETER (GC). THE SDS WAS PUSHED AND PULLED SEVERAL TIMES DUE TO THE INTERACTION WITH THE GC. THE SDS WAS DIFFICULT TO REMOVE, THE STENT GOT CAUGHT ON THE EDGE OF THE GC. THE STENT STRUTS SLIGHTLY BENT AND THE STENT MOVED ON THE BALLOON BUT STILL REMAINED TIGHTLY CRIMPED ON THE BALLOON. THE SDS WITH THE STENT WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. 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 19715736 ↗
• MalfunctionDec 8, 2023Difficult 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 CIRCUMFLEX ARTERY THAT THIS WAS MODERATELY CALCIFIED, AND HEAVILY TORTUOUS. THE XIENCE SKYPOINT DES 3.50 X 15 RX MM STENT DELIVERY SYSTEM FAILED TO CROSS. THE FAILURE TO CROSS WAS DUE TO THE PATIENT¿S ANATOMY. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL. A NON-ABBOTT STENT 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 18297274 ↗
• MalfunctionAug 29, 2023Difficult 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 (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 80% STENOSIS. THE 3.5X15 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643238 ↗
• MalfunctionJul 17, 2023Leak/Splash; Material Rupture; Material Split, Cut or Torn; Leak/Splash; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.50X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS PREPARED WITHOUT ISSUE, AND ADVANCED TO THE TARGET LESION. INFLATION WAS ATTEMPTED ONCE, HOWEVER THE BALLOON DID NOT INFLATE UNDER FLUOROSCOPY. UPON REMOVAL FROM THE ANATOMY, A TEAR WAS NOTED ON THE BALLOON. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335061 ↗
• MalfunctionJun 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 3.50X15MM SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED WITHOUT ISSUE. THE DELIVERY SYSTEM BALLOON WAS THEN USED FOR POST-DILATATION AND INFLATED 3 TIMES. THE FIRST INFLATION WAS TO 14 ATMOSPHERES (ATM) AND PRESSURE WAS HELD FOR 10 SECONDS. SECOND INFLATION WAS TO 14 ATM, PRESSURE WAS HELD FOR 7 SECONDS, AND THE THIRD INFLATION WAS TO 14 ATM, PRESSURE WAS HELD FOR 6 SECONDS WHEN THE BALLOON RUPTURED. THE DELIVERY SYSTEM AND BALLOON WERE REMOVED WITHOUT ISSUE. A SEMI-COMPLIANT AND A NON-COMPLAINT BALLOON WERE USED TO COMPLETE POST-DILATATION WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221166 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE (B)(6) 2022, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND TWO NON-ABBOTT STENTS WERE IMPLANTED. ON (B)(6) 2022, AFTER CONFIRMING THE LESION WITH THE INTRAVASCULAR ULTRASOUND (IVUS) A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A 6FR GUIDE CATHETER WAS INTRODUCED AND THE LESION WAS PRE-DILATED WITH AN UNSPECIFIED BALLOON. THE XIENCE SKYPOINT STENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2022, THE PATIENT DEVELOPED A STROKE AND WAS HOSPITALIZED. THE PATIENT SUBSEQUENTLY RECOVERED AFTER THE STROKE. ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). AN UNKNOWN STENT WAS IMPLANTED SUCCESSFULLY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY BUT THE PATIENT DEVELOPED THROMBOSIS, RESIDUAL EMBOLI IN THE PERIPHERY AND A CARDIOGENIC SHOCK WITH AS (AORTIC STENOSIS). THE PATIENT WAS HOSPITALIZED BUT DIED ON (B)(6) 2023. THE PHYSICIAN STATED THE XIENCE SKYPOINT STENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 17186851 ↗
• MalfunctionMay 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ONTO THE GUIDING CATHETER WITHOUT RESISTANCE, HOWEVER, IT WAS NOTED THAT THE STENT WAS PARTIALLY COMING OFF THE BALLOON. THE WHOLE SYSTEM WAS REMOVED. 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 17035032 ↗
• MalfunctionMar 23, 2023Difficult to Remove; Use of Device Problem; Failure to Advance; Difficult to Remove; Use of Device Problem; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS MILDLY TORTUOUS. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED, BUT FAILED TO REACH THE LESION AND WAS REMOVED WITH RESISTANCE 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 16601641 ↗
• MalfunctionMar 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 LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, THAT WAS MODERATELY CALCIFIED. THE 3.5X15MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED, BUT FAILED TO CROSS THE LESION. IT WAS THOUGHT THAT THE DEVICE WAS REMOVED COMPLETE. HOWEVER, THE STENT WAS LATER FOUND DISLODGED ON THE GUIDEWIRE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. A NEW SAME SIZE XIENCE SKYPOINT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16586765 ↗
• MalfunctionFeb 22, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). TWO POWERTURN GUIDE WIRES WERE ADVANCED TO THEIR INTENDED LOCATION, ONE WIRE DOWN THE DIAGONAL BRANCH. THE 3.5X15MM XIENCE SKYPOINT WAS IMPLANTED, WITHOUT ISSUE, IN THE LAD LESION. DURING REMOVAL OF THE GUIDEWIRE FROM THE DIAGONAL BRANCH, RESISTANCE WAS NOTED, THE GUIDEWIRE BECAME STRETCHED AND, THE SKYPOINT STENT WAS EXPLANTED. A NEW GUIDE WIRE WAS POSITIONED AND A 3.5X18MM XIENCE SKYPOINT WAS ADVANCED AND IMPLANTED IN THE LESION WITHOUT ISSUE. 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 16423006 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 3.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER FAILED TO REACH THE LESION DUE TO THE ANATOMY. RESISTANCE WAS NOTED DURING DEVICE REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. ANOTHER SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142149 ↗
• InjuryDec 22, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS LEFT CIRCUMFLEX ARTERY. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY; HOWEVER, WHEN THE DEVICE WAS REMOVED IT WAS NOTE THAT STENT HAD DISLODGED FROM THE SDS. IT WAS NOTED THAT AN UNSPECIFIED NC TREK BALLOON WAS USED TO FULLY PLACE THE FREE FLOATING STENT AGAINST THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16033661 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE COMPLETE OCCLUSION OF THE LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES. A 6FR 45 CM SHEATH WAS USED AS WELL AS THROMBECTOMY AND A 3.5X18 MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY IN THE DISTAL POPLITEAL ARTERY; HOWEVER, THE ANTERIOR TIBIAL ARTERY (ATA) HAD DECREASED FLOW AND WAS JAILED OFF AFTER DEPLOYMENT. A TWIN PASS CATHETER WAS USED TO AID IN WIRING THE ATA. A 3.0X20 MM TREK BALLOON WAS USED FOR PRE-DILATATION TO 18 ATMOSPHERES AND A 3.5X15 MM XIENCE SKYPOINT STENT WAS DEPLOYED TO THE OSTIAL TO PROXIMAL ATA. A SMALL PERFORATION WAS NOTED IN THE MID ATA SO A 3.5X19 MM GRAFTMASTER COVERED STENT WAS DEPLOYED WITHOUT ISSUE AND FINAL ANGIOGRAM SHOWED EXCELLENT FLOW WITH VESSEL RUNOFF TO THE ANKLE. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 16024272 ↗
• MalfunctionNov 21, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING REMOVAL OF THE STYLET OF THE 3.50X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DIFFICULTY WAS NOTED AND UPON INSPECTION THE CATH LAB TECH NOTED A KINK ON THE TIP OF THE SDS. THE SDS WAS NOT USED IN THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND CLINICALLY SIGNIFCANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15840991 ↗
• InjuryNov 21, 2022Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated; Failure to Advance; Device Damaged by Another Device; Device Dislodged or Dislocated

  RECEIVED MEDWATCH# (B)(4) WHICH STATES: DESCRIBE THE EVENT OR PROBLEM: 1. STENT WENT IN THE BODY IN LEFT MAIN, NOT ABLE TO CROSS TO CIRCUMFLEX, DOCTOR PULLED STENT DEPLOYMENT SYSTEM OUT, NOTICES THE STENT WAS MISSING, UNDER FLUORO THE STENT WAS IN THE LEFT MAIN ARTERY. DOCTOR WAS ABLE TO REMOVE IT UNDER FLUORO WITH A TULIP SNARE. THIS CAUSED THE STENT TO PULL OUT AN EXISTING LEFT MAIN STENT THAT HAD BEEN DEPLOYED EARLY IN THE PROCEDURE. 2. STENT WENT IN THE BODY, CAME OUT UNDEPLOYED. DOCTOR NOTICED A STENT DEFECT. NO PATIENT HARMS WAS NOTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : CCL COMPLEX PCI. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839788 ↗
• MalfunctionNov 4, 2022Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Remove; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS), THE METAL STYLET WAS STUCK/UNABLE TO BE REMOVED AND THE TIP WAS NOTED TO BENT. THE DEVICE WAS FLUSHED PER INSTRUCTIONS FOR USE (IFU) AND PREPPED PRIOR TO STYLET REMOVAL. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735254 ↗
• MalfunctionOct 13, 2022Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 95% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 3X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED WITHOUT ISSUE; HOWEVER, IT WAS NOTED AS WAS VERY DIFFICULT TO SEE VIA X-RAY IMMEDIATELY AFTER IT WAS DEPLOYED IN THE LESION, SO AN ADJUNCTIVE IMAGING TECHNIQUE WAS USED TO VISUALIZE THE 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 15598943 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. THE 3.5X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977823 ↗
• InjuryMay 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) THAT WAS MODERATELY CALCIFIED AND 90% STENOSED. DURING ADVANCEMENT OF THE 3.50 X 15MM XIENCE SKYPOINT STENT SYSTEM, AFTER EXITING THE GUIDE CATHETER, WHILE PULLING THE STENT SYSTEM BACK, THE STENT DISLODGED AND BECAME LOST IN THE BODY. THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF ANOTHER STENT. THE PATIENT REMAINED STABLE WITHOUT ANY COMPLICATIONS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14307214 ↗
• MalfunctionApr 27, 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 LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. ACCESS WAS GAINED VIA THE GROIN AND THE 3.5X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. SLIGHT RESISTANCE WAS FELT DURING REMOVAL OF THE DEVICE FROM THE ANATOMY, AND THE PROXIMAL STENT STRUTS WERE NOTED TO BE FLARED. IT WAS FELT THAT THE FLARED STENT STRUTS OCCURRED FROM A POSSIBLE INTERACTION WITH THE NON-ABBOTT GUIDE CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SKYPOINT DES WAS USED TO CROSS THE ANATOMY AND SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14228851 ↗