XIENCE Skypoint™ 1804400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08717648233487), received between Dec 15, 2020 and Jan 8, 2026 — classified as 9 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (9 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A NON-ABBOTT BALLOON CATHETER. THE 4.0X18MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH SLIGHT RESISTANCE NOTED DUE TO ANATOMY. DURING THE FIRST INFLATION AT APPROXIMATELY 6 ATMOSPHERES, THE BALLOON RUPTURED. THE STENT REMAINED MOUNTED AND THE SYSTEM WAS RETRIEVED WITHOUT ISSUE. ADDITIONAL DILATATIONS WERE PERFORMED SEVERAL TIMES WITH A NC TREK BALLOON, THEN A 3.50X18MM XIENCE SKYPOINT WAS SUCCESSFULLY IMPLANTED. 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 24002703 ↗
• InjuryDec 9, 2025Difficult 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 RIGHT CORONARY ARTERY (RCA) WITH CALCIFICATION. AFTER PRE-DILATATION AND INTRAVASCULAR LITHOTRIPSY, A 2.5X28MM UNSPECIFIED XIENCE STENT, A 3.5X48 UNSPECIFIED STENT AND A 4X18 UNSPECIFIED XIENCE STENT WERE IN IMPLANTED. THEN, A 4X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCE TO THE PROXIMAL RCA WITH RESISTANCE DUE TO THE ANATOMY WHEN THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM. THEREFORE, A 1.5MM UNSPECIFIED BALLOON WAS USED TO IMPLANT THE STENT AT THE TARGET LESION. ANOTHER 4X18MM XIENCE STENT WAS 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 23760441 ↗
• MalfunctionOct 27, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  RETURNED DEVICE ANALYSIS IDENTIFIED THE STENT WAS DISLODGED. THERE WAS NO RUPTURE OR TEAR AS REPORTED BUT THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394442 ↗
• MalfunctionJul 22, 2024Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE 4.0X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE GUIDE CATHETER (GC), THERE WAS RESISTANCE DURING ADVANCEMENT AND DURING REMOVAL WITH THE NON-ABBOTT GUIDING CATHETER (GC). THE SDS WAS REMOVED AND VIA CINE IMAGES, IT WAS OBSERVED THAT THE GC WAS KINKED, AND THE XIENCE STENT HAD DISLODGED INSIDE THE GC. THE STENT WAS RETRIEVED VIA THE GC. A NEW GC WAS USED WITH NEW SAME SIZE XIENCE TO TREAT THE LESION. 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 19796626 ↗
• MalfunctionApr 5, 2024Inflation Problem; Inflation Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS MODERATELY CALCIFED, NON-TORTUOUS AND 70% STENOSED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051966 ↗
• InjuryNov 8, 2023Malposition of Device; Malposition of Device

  IT WAS REPORTED IN A CASE STUDY THAT WAS CONDUCTED FOR A BAILOUT STRATEGY ON STENT PROTRUSION, THAT A 4.0 X 18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED TO TREAT THE OSTIAL LEFT ANTERIOR DESCENDING ARTERY FOR CROSS-OVER STENTING. HOWEVER, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND A SLIGHT STENT PROTRUSION FROM THE LAD INTO THE LEFT MAIN TRUNK (LMT) WAS OBSERVED, WITH JAILED STENT STRUTS AT THE OSTIAL LEFT CIRCUMFLEX (LCX) ARTERY AND MALAPPOSED STENT STRUTS AT THE LMT. THEREFORE, A PROXIMAL OPTIMIZATION TECHNIQUE (POT) WAS PERFORMED USING A NON-ABBOTT BALLOON TO DILATE THE JAILED STRUTS AT THE OSTIUM OF THE LCX. AND EXPANDING THE MALAPPOSED STRUTS AT THE LMT TO PREVENT A DISSECTION. IVUS WAS PERFORMED AGAIN AFTER POT WAS COMPLETED, AND CONFIRMED A WELL-ENLARGED STENT CELL AT THE OSTIAL LCX AND ADEQUATE STENT APPOSITION. A ONE YEAR FOLLOW UP WAS PERFORMED AND CONFIRMED THE STENT WAS PATENT. OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED WITH A DRAGONFLY OPSTAR IMAGING CATHETER, AND CONFIRMED REMARKABLE EXPANSION THE STENT STRUTS WITHOUT ANY RESTENOSIS. RESIDUAL JAILED STRUTS ON THE PROXIMAL SITE OF THE BIFURCATION WAS PRESENT, AND MATERIAL WITH HIGH INTENSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093779 ↗
• InjuryJul 13, 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 MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS PRE-DILATATED WITH A SEMI-COMPLAINT BALLOON A 3.5X48MM XIENCE XPEDITION STENT WAS IMPLANTED WITH NO ISSUES AT 6 ATMOSPHERES. DURING THE 12 MONTH FOLLOW UP HEAVY STENOSIS WAS NOTED IN THE PROXIMAL LAD AND 1ST DIAGONAL ARTERY, AND ON (B)(6) 2023 4.0X18MM XIENCE SKYPOINT STENT WAS IMPLANTED IN PROXIMAL LAD. FIRST DIAGONAL WAS PLANNED TO BE TREATED ON ANOTHER DATE. ON (B)(6) 2023, RESTENOSIS WAS CONFIRMED ONLY AT THE PROXIMAL LAD WHERE THE 4.0X18MM XIENCE SKYPOINT WAS IMPLANTED. A DRUG COATED BALLOON WAS USED TO TREAT THE RESTENOSIS AND TREATMENT OF THE 1ST DIAGONAL WAS TERMINATED AS AN UNSPECIFIED GUIDE WIRE FAILED TO CROSS THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17317450 ↗
• MalfunctionJul 7, 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 RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 4.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS THE LESION. RESISTANCE WAS MET WITH THE LESION DURING REMOVAL BUT THE DEVICE WAS REMOVED INDEPENDENTLY. A NON-ABBOTT STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280367 ↗
• InjuryMay 5, 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 LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4.0X18MM XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT COMPLAINED OF ITCHY HANDS AND FEET, FLUSHING, AND HIVES. HE TOOK ZYRTEC AND BENADRYL AND THE SYMPTOMS SUBSIDED FOR A DAY. THE FOLLOWING DAY, (B)(6) 2023, HE EXPERIENCED HICCUPS THAT LASTED ALL DAY LONG, AND DIFFICULTY SWALLOWING DUE TO PRESSURE AND PAIN IN HIS THROAT. EATING AND DRINKING LIQUIDS WAS DIFFICULT DUE TO THE PAIN IN HIS THROAT. HE WENT TO URGENT CARE WHERE A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH SHOWED IRRITATION OF THE CHEST AND INFLAMMATION AROUND THE HEART. THE PHYSICIAN COULD NOT EXPLAIN ANYTHING AND SUGGESTED HE FOLLOW UP WITH HIS PRIMARY CARE PHYSICIAN. HE FOLLOWED UP WITH HIS PRIMARY CARE PHYSICIAN; HOWEVER, AN ENDOSCOPY PROCEDURE COULD NOT BE PERFORMED DUE TO THE DISCOMFORT IN HIS THROAT. HE THEN STARTED TO FEEL IMMENSE PAIN IN HIS JOINTS AND COULD NOT WALK. HE CONSULTED WITH A RHEUMATOLOGIST AND BLOOD WORK WAS PERFORMED WHICH SHOWED INFLAMMATORY MARKERS WERE ELEVATED. HE WAS PRESCRIBED PREDNISONE FOR THE JOINT PAIN. THE JOINT PAIN WAS BETTER BY (B)(6) 2023. HE THEN S

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Pain; Swelling/ Edema

  MAUDE report 16881363 ↗
• MalfunctionFeb 16, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, 70% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). TWO STENTS, A 4.50X18MM, AND A 4.0X18MM XIENCE SKYPOINT DRUG ELUTING STENTS (DES) COULD NOT BE ADVANCED THROUGH THE NON-ABBOTT GUIDE EXTENSION CATHETER AND DISLODGED OUTSIDE THE PATIENT ANATOMY INSIDE OF THE GUIDE EXTENSION CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW, 4.5X18MM SKYPOINT DES WAS ABLE TO BE DELIVERED THROUGH A NEW NON-ABBOTT GUIDE EXTENSION CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392338 ↗
• InjuryJul 11, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA) AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. THE 3.50X18MM AND 4.0X18MM SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION IN THE MID RCA, DUE TO THE ANATOMY. BOTH SDS WERE REMOVED WITHOUT ISSUE, HOWEVER AFTER THE 4.0X18MM SKYPOINT WAS REMOVED A DISSECTION WAS OBSERVED. IT IS UNKNOWN WHICH OF THE TWO SDS CAUSED THE DISSECTION. THE DISSECTION WAS TREATED WITH BALLOONING AND AN UNSPECIFIED STENT. A 3.0X23MM SKYPOINT WAS ADVANCED IN THE CIRCUMFLEX ARTERY, HOWEVER IT FAILED TO CROSS TO THE TARGET LESION DUE TO THE CALCIFICATION. THE SDS WAS REMOVED WITHOUT ISSUE AND A NON-ABBOTT SDS WAS ABLE TO CROSS. A DISSECTION WAS OBSERVED, IT IS UNKNOWN WHICH SDS CAUSED THE DISSECTION, THE ABBOTT SDS OR THE NON-ABBOTT STENT. THE DISSECTION WAS TREATED WITH THE NON-ABBOTT STENT THAT CROSSED. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14982741 ↗
• MalfunctionJun 29, 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 UNSPECIFIED LESION. THE 4.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS MET DURING REMOVAL OF THE SDS WITH ANATOMY. 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 14853162 ↗
• MalfunctionJun 23, 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 75% STENOSED, MODERATELY CALCIFIED AND MODERATELY TORTUOUS VESSEL IN THE RIGHT CORONARY ARTERY (RCA). A 3.5MM XIENCE STENT DELIVERY SYSTEM (SDS) WAS DEPLOYED IN THE MID RCA, HOWEVER, THE 4.0X18MM XIENCE SKYPOINT MET RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION IN THE PROXIMAL RCA. THE DISTAL EDGE OF THE STENT WAS NOTED TO BE FLARED. RESISTANCE WAS MET WITH THE LESION CALCIFICATION DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788509 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED DUE TO EXPERIENCING AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) IN THE RIGHT CORONARY ARTERY (RCA). THREE XIENCE SKYPOINT STENTS WERE IMPLANTED, A 3.50X33MM, 3.50X8MM AND A 4.00X18MM. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED TO TREAT A DIFFERENT VESSEL; HOWEVER, IT WAS NOTED THAT THE THREE STENTS WERE OCCLUDED WITH THROMBUS. THEREFORE, ADDITIONAL STENTS WERE IMPLANTED TO TREAT THE THROMBOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14349964 ↗
• InjuryMay 7, 2022Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING THE INTERVENTION, WHILE TRYING TO ADVANCE THE XIENCE SKYPOINT DRUG ELUTING CORONARY STENT INTO A NON-ABBOTT STENT THAT WAS PREVIOUSLY IMPLANTED, THE SKYPOINT STENT DISLODGED. ANOTHER BALLOON WAS USED TO SNARE THE STENT OUT OF THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14320350 ↗
• MalfunctionApr 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 LEFT CIRCUMFLEX ARTERY THAT WAS BOTH HEAVILY CALCIFIED, TORTUOUS AND 90% STENOSED. DURING ADVANCEMENT OF THE 4.00X18MM XIENCE SKYPOINT STENT SYSTEM, RESISTANCE WAS MET AND THE DEVICE FAILED TO CROSS THE LESION. RESISTANCE WAS NOTED DURING REMOVAL OF THE DEVICE. 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 14197591 ↗
• MalfunctionApr 25, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, HEAVILY TORTUOUS PROXIMAL CIRCUMFLEX CORONARY ARTERY. THE 4.0X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL OF THE SDS AS A SINGLE UNIT. A NON-ABBOTT 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 14194092 ↗
• MalfunctionMar 18, 2022Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X18 MM SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS NOT PREPARED OUTSIDE OF THE BODY. THE (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. THE SDS WAS INFLATED ONCE TO NOMINAL PRESSURE. DURING DEFLATION NEGATIVE PRESSURE WAS HELD FOR SEVERAL SECONDS, SEVERAL TIMES, THE BALLOON DID NOT FULLY DEFLATE. WHEN ATTEMPTING TO REMOVE THE SDS, THE SDS GOT STUCK IN THE GUIDE CATHETER SINCE THE BALLOON WAS WITHDRAWN PARTIALLY DEFLATED. THE SDS AND GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT. A NEW GUIDE CATHETER AND NON-COMPLIANT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13811479 ↗
• MalfunctionFeb 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-RIGHT CORONARY ARTERY. AFTER PRE-DILATATION, A 4.0 X 18 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, AND THE BALLOON INFLATION WAS ATTEMPTED; HOWEVER, THE BALLOON OF THE SDS RUPTURED AT 8 ATMOSPHERES DURING FIRST INFLATION. AN NC TREK WAS USED FOR POST-DILATATION TO COMPLETE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AN NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620558 ↗
• InjuryDec 14, 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 MULTIPLE LESIONS ON THE LEFT SIDE. TWO NON-ABBOTT STENTS WERE IMPLANTED AND 3 XIENCE SKYPOINT STENTS WERE IMPLANTED. A 4.0X8MM XIENCE SKYPOINT WAS PLACED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH OVER 90% STENOSIS AND A 2.5X15 XIENCE SKYPOINT WAS PLACED IN THE PROXIMAL LEFT CIRCUMFLEX WITH OVER 80% STENOSIS. THE ANGIOGRAM TAKEN AT THE END OF THE CASE WAS CLEAR AND OPEN. DURING THIS CASE THE PATIENT WAS ON HEART PUMP; HOWEVER, NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY WAS REPORTED. HOWEVER, 30 MINUTES LATER THE PATIENT CAME BACK TO THE CATH LAB WITH CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED BY MULTIPLE STAFF MEMBERS AND A HEART PUMP WAS USED AGAIN. THE PATIENT HAD ACUTE STENT THROMBOSIS OF BOTH THE 4.0X8MM XIENCE SKYPOINT AND THE 2.5X15 XIENCE SKYPOINT. THE LESIONS WERE RE-WIRED AND NON-COMPLIANT BALLOONS WERE USED TO OPEN THE THROMBOSIS. ASPIRATION WAS ALSO USED TO REMOVE THE CLOT. THE PATIENT WAS STABILIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Thrombosis/Thrombus

  MAUDE report 13006006 ↗
• MalfunctionNov 20, 2021Unintended System Motion; Malposition of Device; Difficult to Advance; Unintended System Motion; Malposition of Device; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (PRCA). AN UNSPECIFIED GUIDE CATHETER WAS ADVANCED THROUGH THE LEFT RADIAL; HOWEVER, THE DEVICE CAUSED A DISSECTION. THE DISSECTION WAS COVERED WITH AN UNSPECIFIED STENT. THE 4.0X18MM XIENCE SKYPOINT WAS ADVANCED EVEN THOUGH RESISTANCE WAS MET WITH ANATOMY. THE STENT WAS DEPLOYED, BUT WATERMELON SEEDED OUT OF THE LESION ON THE BALLOON AND STILL ON THE WIRE TO THE AORTA. THE PHYSICIAN PULLED BACK THE STENT DELIVERY SYSTEM WITH THE STENT TO THE RADIAL ARTERY AND DEPLOYED THE STENT THERE. ACCESS FROM THE RIGHT GROIN WAS OBTAINED AND ANOTHER 4X28MM UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12849766 ↗
• InjurySep 9, 2021Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). THE 4.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE DEPLOYED AT NOMINAL PRESSURE; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES. IT WAS CONFIRMED THAT THE CONTRAST LEAKED OUT OF THE BALLOON. POST DILATATION WAS PERFORMED FOLLOWED BY INTRAVASCULAR ULTRA SOUND (IVUS) TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA 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 12449035 ↗
• MalfunctionAug 20, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). THE 4.0 X 18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED OVER THE WHISPER EXTRA SUPPORT GUIDE WIRE. RESISTANCE WAS NOTED DURING ADVANCEMENT, AND THE STENT DELIVERY SYSTEM BECAME STUCK. THE STENT DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE GUIDE WIRE. BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. 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 12351285 ↗
• MalfunctionJun 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE VERY TORTUOUS MID CIRCUMFLEX CORONARY ARTERY. A NON-ABBOTT GUIDE EXTENSION WAS PRESENT IN THE ARTERY FOR VISUALIZATION AND THE 4.00X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM (SDS), THE BALLOON BECAME CAUGHT ON THE GUIDE EXTENSION. THE TWO DEVICES WERE REMOVED TOGETHER AS A SYSTEM AS THEY WERE STUCK TOGETHER. 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 12097366 ↗
• MalfunctionDec 15, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, TORTUOUS AND 90% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A NON-ABBOTT BALLOON, A 4.0X18MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE LESION AND THE STENT DEPLOYED AND IMPLANTED AT 14 ATMOSPHERES FOR 10 SECONDS; HOWEVER, DEFLATION SEEMED SLOW. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED, WITHOUT REPORTED ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11013148 ↗