XIENCE Skypoint™ 1804300-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648233272), received between Apr 13, 2021 and Jan 28, 2026 — classified as 1 death, 7 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY TORTUOSITY. THE LESION WAS PRE-DILATED WITH NON-ABBOTT BALLOONS. THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ATTEMPTED TO BE USED WITH A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL II GUIDE WIRE BUT THE WIRE WAS KINKED SO IT WAS NOT USED. THE SECOND BMW UNIVERSAL II WAS USED WITH THE DRAGONFLY BUT THE DEVICES MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND A KINK IN THE WIRE WAS NOTED. UPON REMOVAL THE DEVICES WERE STUCK TOGETHER AND THE GUIDE WIRE WAS INADVERTENTLY REMOVED WITH THE DRAGONFLY. AT AN UNSPECIFIED POINT IN THE PROCEDURE, A 3X33 MM XIENCE STENT WAS DEPLOYED IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). A DISSECTION WAS NOTED AND AN ATTEMPT TO TREAT THE DISSECTION WAS UNSUCCESSFUL DUE TO THE BMW UNIVERSAL II GUIDE WIRES, PILOT GUIDE WIRES AND WHISPER GUIDE WIRE KEPT LOSING POSITION. ADDITIONALLY, FIVE XIENCE SKYPOINT STENT DELIVERY SYSTEMS (SDS) FAILED TO CROSS THE LESION DUE TO THE XIENCE STENT IN THE DRCA. THE STENT WAS NOTED TO HAVE THROMBOSIS. THE PROCEDURE LASTED 3.5 HOURS. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT. THE PATIENT CODED WHI

  Patient problems: Cardiac Arrest; Obstruction/Occlusion; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 24203695 ↗
• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO THE MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X33MM XIENCE STENT WAS DEPLOYED; HOWEVER, THE MIDDLE PORTION OF THE STENT FAILED TO EXPAND. THREE INFLATION AT 16 ATMOSPHERES FOR 30 SECONDS EACH WERE ATTEMPTED; HOWEVER, THE STENT REMAINED UNDER EXPANDED. FURTHER DILATION WAS PERFORMED WITH A 2.5MM NON-ABBOTT BALLOON AT 22 ATMOSPHERES. 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 23790648 ↗
• MalfunctionAug 21, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE OBTUSE MARGINAL BRANCH OF THE LEFT CIRCUMFLEX ARTERY. THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DESPITE NOT NOTING RESISTANCE OR UNUSUAL ANATOMY. ONCE REMOVED, THE STENT WAS OBSERVED TO BE HANGING HALFWAY OFF THE UNINFLATED BALLOON OF THE XIENCE SKYPOINT DELIVERY SYSTEM. THERE WAS NO RESISTANCE DURING REMOVAL. A NEW SMALLER AND SHORTER STENT 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 22868604 ↗
• InjuryDec 5, 2024Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WHEN THE ENGAGEMENT OF THE GUIDING CATHETER BECAME UNSTABLE AND RESISTANCE WAS NOTED WITH THE GUIDING CATHETER DURING ADVANCEMENT. WHILE PUSHING AND PULLING THE SDS AROUND THE GUIDING CATHETER WITH RESISTANCE, THE STENT HIT THE EDGE OF THE GUIDING CATHETER CAUSING STENT DEFORMATION AND DISPLACEMENT ON THE BALLOON. THE STENT REMAINED ON THE BALLOON AND THE ENTIRE SDS WAS ULTIMATELY RETRIEVED VIA SNARE, USING A FEMORAL APPROACH. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA 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 20855499 ↗
• MalfunctionSep 26, 2024Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.00X33MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED HOWEVER, FAILED TO CROSS THE LESION DUE TO THE ANATOMY. DURING WITHDRAWAL RESISTANCE WAS NOTED WITH THE GUIDING CATHETER AND THE STENT STRUTS ON THE DISTAL EDGE OF THE STEN WERE FLARED. ANOTHER SAME SIZED SKYPOINT DES WAS USED, AND THE PROCEDURE WAS COMPLETED. 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 20310937 ↗
• MalfunctionJun 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON OF THE SDS WAS INFLATED TO 12 ATMOSPHERES (ATM). HOWEVER, THE BALLOON RUPTURED AT 14 ATM DURING THE SECOND INFLATION. THE STENT WAS SUCCESSFULLY DEPLOYED AND THE SDS WAS REMOVED FOR THE PATIENT. 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 19455311 ↗
• MalfunctionJan 5, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH 99% STENOSIS, MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. 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 18460630 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 6 FRENCH SHEATH WAS USED. THE BMW GUIDEWIRE (GW) WAS ADVANCED WITH DIFFICULTY; HOWEVER, WAS ABLE TO BE POSITIONED INTO THE DISTAL VESSEL. FOR PRE-DILATATION, THE 3.00X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND THE BALLOON WAS INFLATED ONE TIME TO 12 ATMOSPHERES (ATM); HOWEVER, THE MID SEGMENT DID NOT EXPAND DUE TO ECCENTRIC CALCIFICATION. THE BDC WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER NC TREK BALLOON TO COMPLETE PRE-DILATATION. THEN, THE 3.00X33NN XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS DEPLOYED; HOWEVER, SOME CONTRAST EXTRAVASATION FROM THE MID LAD WAS NOTED. THEREFORE THE BALLOON OF THE SDS WAS RE-INFLATED FOR 5 MINUTES, BUT THE PATIENT CONTINUED TO BLEED. THEREFORE, THE 2.80X16MM RX GRAFTMASTER COVERED STENT WAS ADVANCED TO THE PERFORATION WITH DIFFICULTY AND DEPLOYED AT 15 ATMOSPHERES (ATM), BUT THE THE STENT DID NOT COMPLETELY COVER THE PERFORATION. THE PERFORATION WAS TREATED WITH A NON-ABBOTT STENT. THE PATIENT EXPERIENCED CHEST PAIN POST PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DE

  Patient problems: Angina; Perforation of Vessels; Pericardial Effusion

  MAUDE report 15440885 ↗
• MalfunctionAug 15, 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 MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. THERE WAS RESISTANCE NOTED WITH ANATOMY DURING REMOVAL OF THE SDS. A NON-ABBOTT STENT 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 15229547 ↗
• MalfunctionJul 26, 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 RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103967 ↗
• MalfunctionMay 3, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, MODERATELY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE OBTUSE MARGINAL (OM) ARTERY. THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE SDS WAS REMOVED AS A SINGLE UNIT. 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 14269849 ↗
• DeathApr 26, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS PERFORMED ON A PATIENT WITH ACUTE MYOCARDIAL INFARCTION WHO WAS TAKEN FROM A DIFFERENT HOSPITAL. COMPLETE OCCLUSION ON RIGHT CORONARY ARTERY (RCA), LEFT CIRCUMFLEX (LCX), AND ACUTE CORONARY SYNDROME (ACS) DUE TO THE HEAVY STENOSIS ON LEFT ANTERIOR DESCENDING (LAD) ARTERY WERE NOTED. THROMBECTOMY WAS PERFORMED ON THE LAD. AFTER INTRAVASCULAR ULTRASOUND (IVUS) PRE-DILATATION WAS PERFORMED ON THE PROXIMAL LAD WITH AN UNSPECIFIED BALLOON CATHETER. A 3.5X23 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) AND 3.0X33MM XIENCE SKYPOINT SDS WERE DEPLOYED AT THE PROXIMAL LAD AND THE MID LAD. CALCIFICATION IN THE DISTAL LEFT CIRCUMFLEX (LCX) WITH 100% STENOSIS, LESION LENGTH 35MM, LESION RADIUS 2.5MM AND TORTUOSITY AND HEAVY CALCIFICATION IN THE PROXIMAL LCX WITH 100% STENOSIS, LESION LENGTH 10MM, AND LESION RADIUS 2.75MM WERE NOTED. A NON-ABBOTT GUIDE WIRE AND GUIDING CATHETER WERE INSERTED INTO THE LCX. AFTER PRE-DILATATION BY A NON-ABBOTT BALLOON CATHETER IN THE LCX, A NON-ABBOTT STENT WAS DEPLOYED AT THE PROXIMAL LCX AND DISTAL LCX, WITHOUT POST-DILATATION. THE STENT EXPANSION WAS CONFI

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 14215017 ↗
• InjuryApr 22, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT FROM THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) DISLODGED. THE STENT WAS RETRIEVED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187933 ↗
• MalfunctionApr 20, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CIRCUMFLEX ARTERY. THE 3.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL OF THE SDS RESISTANCE WAS MET WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161966 ↗
• MalfunctionMar 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED A XIENCE SKYPOINT 3 X 33 DRUG ELUTING STENT (DES) BOX WAS PULLED OFF THE SHELF, BUT ONCE OPENED, A XIENCE SKYPOINT 3 X 23 DES WAS FOUND INSIDE THE BOX. THEREFORE, THE DEVICE WAS DISCARDED AND REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13686389 ↗
• MalfunctionSep 21, 2021Difficult 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 THE HEAVILY CALCIFIED, MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.00X33 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PUSHED WITH FORCE TOWARDS THE LESION BUT FAILED TO CROSS DUE TO RESISTANCE WITH THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL AND UPON REMOVAL THE STENT WAS NOTED TO BE FLARED. A MICRO CATHETER AND A NEW XIENCE SDS WERE 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 12507443 ↗
• MalfunctionSep 2, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. THE 3.00X33 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO REACH THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. A NON-ABBOTT STENT 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 12417898 ↗
• InjuryAug 26, 2021Adverse 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 HIGHLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3X33MM XIENCE SKYPOINT STENT WAS ADVANCED AND IMPLANTED AT THE LESION WITHOUT ISSUE. WHEN PERFORMING STANDARD POST-DILATATION WITH A 3.5X12MM NC TREK BALLOON IT WAS INFLATED ONCE AT AN UNSPECIFIED ATMOSPHERE AND IT WAS NOTED THAT A PERFORATION OCCURRED. A RX GRAFTMASTER STENT WAS USED TO TREAT THE PERFORATION AND SEALED IT SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 12370849 ↗
• MalfunctionJul 27, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  ADDITIONAL INFORMATION: THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-ABBOTT STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229373 ↗
• InjuryApr 13, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED, A NON-ABBOTT ATHERECTOMY SYSTEM WAS USED. THE OCT HAD AN UNSPECIFIED ERROR AND WAS REPLACED WITH AN UNSPECIFIED INTRAVASCULAR ULTRASOUND CATHETER. A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION WITH A NON-ABBOTT GUIDE WIRE. A 3X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, AND THE STENT WAS IMPLANTED. HOWEVER, THE PROXIMAL PORTION OF THE STENT WAS NOT EXPANDED ENOUGH, SO A NON-COMPLIANT NON-ABBOTT BALLOON WAS USED FOR POST-DILATATION. THE PATIENT'S BLOOD PRESSURE DECREASED, AND A PERFORATION WAS NOTED. AN UNSPECIFIED GRAFTMASTER COVERED STENT WAS IMPLANTED, BUT THERE WAS BLEEDING SOMEWHERE ELSE IN THE PATIENT. HEART MASSAGE WAS USED AS TREATMENT AS WELL, BUT THE PATIENT EXPIRED ON (B)(6) 2021. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 11656748 ↗