XIENCE Skypoint™ 1804300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648233241), received between Mar 30, 2021 and Apr 9, 2026 — classified as 1 death, 6 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (17 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE 3.0X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED FOR DEPLOYMENT TO 16 ATMOSPHERES AND THE BALLOON RUPTURED. IT APPEARED THE STENT MIGRATED ON ANGIO BUT POST DEPLOYMENT THE STENT WAS IN THE CORRECT LOCATION. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837201 ↗
• MalfunctionMar 26, 2026Leak/Splash

  IT WAS REPORTED THAT DURING PREPARATION, A 3.0X18 MM XIENCE SKYPOINT WAS UNABLE TO PULL NEGATIVE PRESSURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702067 ↗
• MalfunctionMar 2, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. AFTER PRE-DILATION, THE 3 X 18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. HOWEVER, DURING THE INITIAL INFLATION THE DELIVERY SYSTEM BALLOON RUPTURED AT 6 ATMOSPHERES (ATM). THE STENT REMAINED MOUNTED ON THE DELIVERY SYSTEM AND THEREFORE, WAS ABLE TO BE REMOVED WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS CONTINUED WITH ADDITIONAL DILATATION FOLLOWED BY IMPLANTATION OF A 2.75 X 18 MM XIENCE SKYPOINT STENT AND POST-DILATATION. 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 24484493 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID (B)(6) IT WAS REPORTED THAT THE LEFT HEART CATHETERIZATION PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION, WITH SEVERE 70 TO 75% STENOSIS, IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. CIRCUMFERENTIAL 360 DEGREE CALCIFICATION WAS CONFIRMED BY OPTICAL COHERENCE TOMOGRAPHY. INTRAVENOUS LITHOTRIPSY (IVL) WAS PERFORMED WITH THE ABBOTT IVL DEVICE. THERE WAS VERY GOOD RESULT WITH SOME PLAQUE SHIFT INTO THE DISTAL DIAGONAL BRANCH, BUT TIMI 3 FLOW WAS STILL GOOD INTO THIS DIAGONAL. THE 2.75 X 15 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE LAD, RESULTING IN VERY GOOD ANGIOGRAPHIC RESULTS. THE CASE MOVED ON TO THE SMALL DIAGONAL BRANCH, BUT THE BALLOON DILATATION CATHETER WAS UNABLE TO CROSS. AT THIS TIME, THE LAD STENT APPEARED TO BE DEVELOPING THROMBUS. A SECOND 3.0 X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE FIRST STENT, RESULTING IN TIMI 3 FLOW. THERE WAS NO RESIDUAL STENOSIS; HOWEVER, THE SMALL DIAGONAL BRANCH WAS LOST (OCCLUDED). AT THIS TIME, THE PATIENT REPORTED CHEST PAIN. THROMBUS WAS AGAIN NOTED IN THE LAD STENT. A THIRD 3.0 X 23 MM XIENCE SKYPOINT STENT WAS PLACED, SUCCESSFULLY TREATING THE THROMBOSED STENT. THE PATIENT WAS DOING WELL AND THE PROCEDU

  Patient problems: Angina; Thrombosis/Thrombus

  MAUDE report 22651723 ↗
• MalfunctionJun 23, 2025Defective Device; Defective Device

  SUBSEQUENT TO THE INITIALLY FILED REPORT, RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE STENT WAS THE CORRECT LENGTH. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309328 ↗
• MalfunctionFeb 13, 2025Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 90% STENOSED. PRE-DILATION WAS PERFORMED WITH A 2.5X15MM NON-ABBOTT BALLOON. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND RESISTANCE WAS MET WITH THE CALCIFICATION. DURING DEPLOYMENT, THE BALLOON ON THE SDS RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES AND THE STENT FAILED TO DEPLOY. THE SDS WAS SIMPLY WITHDRAWN WITH THE STENT. ADDITIONAL PRE-DILATION WAS PERFORMED USING THE SAME 2.5X15MM NON-ABBOTT BALLOON AND A NEW 3.0X23MM XIENCE SKYPOINT STENT WAS PLACED 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 21376114 ↗
• DeathNov 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT IT WAS REPORTED THAT THE 3.5X28 MM XIENCE SKYPOINT STENT WAS ALSO LOCATED IN THE LEFT MAIN AS THE STENTS WERE LAYERED. STENT THROMBOSIS WITH MYOCARDIAL ISCHEMIA WAS THE CAUSE OF DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Hypoxia; Ischemia; Low Blood Pressure/ Hypotension; Nausea; Non specific EKG/ECG Changes; Respiratory Failure; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 20725187 ↗
• InjuryAug 15, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). REPORTEDLY AFTER PRE-DILATATION, A 3.00X 18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WAS NOTED WITH A PREVIOUSLY IMPLANTED STENT. THE DES WAS REMOVED, AND IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS FREE FLOATING IN THE RCA. A 3.5X38MM XIENCE DES WAS DEPLOYED TO CRUSH THE FLOATING STENT AGAINST THE VESSEL WALL. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER XIENCE STENT. THERE WERE 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 19990970 ↗
• MalfunctionJul 10, 2024Difficult 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 MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA) LESION. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND MET RESISTANCE WITH A PREVIOUSLY IMPLANTED STENT THAT HAS RESTENOSIS. DURING WITHDRAWAL, THE SDS AGAIN INTERACTED WITH THE PREVIOUSLY IMPLANTED STENT CAUSING THE STENT TO DISLODGE AND BECOME FREE-FLOATING ON AN UNSPECIFIED GUIDE WIRE. A 3.5X23 XIENCE SKYPOINT STENT WAS DEPLOYED TO SECURE THE FREE-FLOATING STENT. DURING PREP OF A SECOND PLANNED 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM, THE SDS WAS REMOVED FROM THE DISPENSER HOOP AND THE CATHETER WAS KINKED. SUBSEQUENTLY, THE DISPENSER WAS NOTED TO BE KINKED. THEREFORE, A THIRD 3.0X18MM XIENCE SKYPOINT WAS ATTEMPTED TO CROSS THE LESION YET FAILED TO CROSS DUE TO INTERACTION WITH THE FIRST IMPLANTED JAILED STENT. UPON WITHDRAWAL, THE SDS BECAME STUCK IN THE GUIDE LINER, THEREFORE, BOTH WERE REMOVED TOGETHER AS ONE UNIT. THE STENT STRUTS WERE NOTED TO BE BENT UPWARDS WHICH DID NOT ALLOW FOR PASSAGE THROUGH THE GUIDE LINER. THE PROCEDURE LASTED ALMOST 4 HOURS BUT THERE WAS NO HARM TO THE PATIENT. THERE WERE NO ADVERSE PATIENT SEQUELA. N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716406 ↗
• InjuryJul 10, 2024Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT, IT WAS REPORTED THE STENT DISLODGED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND FREE-FLOATED TO THE MID RCA ON AN UNSPECIFIED GUIDE WIRE. RETRIEVAL WAS ATTEMPTED USING AN UNSPECIFIED BUDDY WIRE THEN A 1.0MM SAPPHIRE BALLOON DILATATION CATHETER (BDC) WAS ADVANCED OVER THE BUDDY WIRE PAST THE STENT AND INFLATED IN AN ATTEMPT TO PULL THE STENT BACK, YET THIS WAS UNSUCCESSFUL. AN UNSPECIFIED LARGER BALLOON WAS THEN USED; HOWEVER, THE STENT WAS PUSHED FURTHER DOWN THE VESSEL. A SNARE WAS ALSO USED IN AN ATTEMPT TO REMOVE THE STENT, BUT THIS WAS ALSO UNSUCCESSFUL. THEREFORE, A 3.5X23 XIENCE SKYPOINT STENT WAS DEPLOYED AND POST DILATED SEVERAL TIMES TO SECURE THE FREE-FLOATING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19716318 ↗
• MalfunctionMay 21, 2024Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. PRE-DILATION WAS PERFORMED SEVERAL TIMES WITH A 2.5X15 NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH VESSEL CALCIFICATION. PRESSURE WAS APPLIED ONCE WHEN THE BALLOON RUPTURED AT 6 ATMOSPHERES AND THE STENT DID NOT DEPLOY AND REMAINED MOUNTED ON THE SDS. THE SDS WAS SUSPECTED OF HAVING A PINHOLE FROM THE VESSEL CALCIFICATION. THE SDS WAS WITHDRAWN INTACT. ADDITIONAL DILATATION WAS PERFORMED WITH THE NON-ABBOTT BALLOON SEVERAL TIMES, THEN A 2.75X18MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. POST DILATION WAS PERFORMED WITH A NON-ABBOTT BDC. 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 19361719 ↗
• MalfunctionApr 2, 2024Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION, MILD TORTUOSITY. REPORTEDLY, WHEN THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION, THE XIENCE STENT WAS CAUGHT ON THE DISTAL EDGE OF THE GUIDING CATHETER. THE STENT DEFORMED AND THE STENT MOVED ON THE SDS BALLOON. THE SDS AND THE STENT WAS REMOVED VIA THE FEMORAL SITE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19025308 ↗
• MalfunctionApr 1, 2024Improper 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 THE PROCEDURE WAS TREAT A LESION IN THE DISTAL CIRCUMFLEX ARTERY. THE 3.0X18MM XIENCE SKYPOINT STENT WAS IMPLANTED ON (B)(6) 2024; HOWEVER, POST PROCEDURE IT WAS NOTED THAT THE STENT EXPIRED ON (B)(6) 2024. 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 19015805 ↗
• MalfunctionFeb 2, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH 90% STENOSIS, MODERATE CALCIFICATION AND MODERATE TORTUOSITY. PRE-DILATATION WAS PERFORMED USING A 2.5X10MM BALLOON. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE LESION DURING ADVANCEMENT AND RUPTURED AT 6 ATMOSPHERES (ATMS) DUE TO THE CALCIFICATION. THE STENT WAS REMOVED ALONG WITH THE BALLOON. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE AND 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 18635712 ↗
• MalfunctionNov 27, 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 HEAVILY CALCIFIED, HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) THAT IS 99% STENOSED. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. THERE WAS RESISTANCE FELT WITH ANATOMY DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213283 ↗
• MalfunctionAug 24, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. AFTER ABLATION A NON-ABBOTT 2.75X15MM BALLOON WAS USED TO ADDITIONALLY DILATE THE LESION. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. DURING AN ATTEMPT TO DEPLOY, THE BALLOON RUPTURED AT 5 ATMOSPHERES. THE STENT WAS NOT DEPLOYED; THEREFORE, THE SDS WAS REMOVED. ANOTHER 2.75X15MM NON-ABBOTT BALLOON WAS USED TO DILATE THE LESION AGAIN, A NON-ABBOTT STENT WAS IMPLANTED AND 3.0X15MM NON-ABBOT BALLOON 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 17614507 ↗
• MalfunctionJul 25, 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 CIRCUMFLEX (LCX) ARTERY. THE BIFURCATION WAS ACUTE. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE ANATOMY AND FAILED TO CROSS. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL BUT WAS REMOVED INDEPENDENTLY. A BALLOON WAS ATTEMPTED TO CROSS BUT ALSO FAILED DUE TO THE ANATOMY AND THE PROCEDURE WAS ABORTED. 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 17393324 ↗
• MalfunctionMar 7, 2023Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). AN UNSPECIFIED GUIDE WIRE (GW) WAS IN THE PATIENT ANATOMY AND A 3.00X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED ONTO THE GUIDE WIRE. RESISTANCE WAS NOTED AND THE DES WAS REMOVED WITHOUT DIFFICULTY. THE GUIDE WIRE WAS RE-SATURATED AND THE SKYPOINT DES WAS RE-ADVANCED; HOWEVER, IT WAS NOTED THAT THE STENT HAD DISLODGED; IT HAD MOVED BACK ON THE DELIVERY SYSTEM, FULLY OFF THE BALLOON, BUT REMAINING ON THE DELIVERY SYSTEM. THE SKYPOINT DES WAS NOT IN THE ANATOMY AT THE TIME THE STENT DISLODGED. A SECOND XIENCE SKYPOINT WAS USED OVER THE SAME GUIDE WIRE 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 16499259 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0X18 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION OVER A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE (GW). THE STENT WAS DEPLOYED SUCCESSFULLY IN A BENT SECTION OF THE LAD. THERE WAS RESISTANCE DURING RETRACTION OF THE GW AND THE GW WAS TRAPPED UNDER THE STENT STRUTS. THE GW WAS FINALLY REMOVED (SIMPLY WITHDRAWN), AND THE GW WAS NOTED EXTREMELY ELONGATED AND DEFORMED BUT STILL INTACT. THE STENT WAS EXPLANTED AND TANGLED UP. A NEW WHISPER GUIDE WIRE AND AN NC TREK WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE AND ANOTHER SAME SIZE XIENCE SKYPOINT WAS IMPLANTED TO TREAT THE TARGET LESION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION REGARDING THIS ISSUE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15928862 ↗
• MalfunctionNov 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 3.0X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND THERE WAS RESISTANCE DURING REMOVAL WITH THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS. A 3.0X15 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835597 ↗
• MalfunctionOct 4, 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 MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT WITH THE LESION AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE DURING REMOVAL. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. ANOTHER DEVICE 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 15539092 ↗
• InjuryJul 20, 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 HAD A 3X18MM XIENCE SKYPOINT STENT IMPLANTED. ON(B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE POST PROCEDURAL CARDIAC DISTURBANCES. THE PATIENT WAS TREATED VIA PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 15069061 ↗
• InjuryJul 15, 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 AFTER EXPERIENCING A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND A 3X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED DUE TO A CEREBRAL INFARCTION. ON (B)(6) 2022 THE PATIENT WAS RE-HOSPITALIZED A SECOND TIME WITH HYPOTENSION. THE PATIENT DID NOT RECEIVE TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Stroke/CVA

  MAUDE report 15033846 ↗
• MalfunctionJun 27, 2022Difficult 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 HEAVILY CALCIFIED AND TORTUOUS 90% STENOSED FIRST OBTUSE MARGINAL ARTERY. THE 3.0 X 18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED AND THE SDS WAS UNABLE TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL, RELATED TO THE VESSEL AND LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NOT CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837244 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE DISTAL RIGHT CORONARY ARTERY (DRCA). THE 3.0X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS RESISTANCE MET WITH THE LESION DURING REMOVAL. 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 14788590 ↗