XIENCE Skypoint™ 1804400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648233463), received between Aug 18, 2021 and May 1, 2025 — classified as 5 injuries, 15 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 16, 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.

• InjuryMay 1, 2025Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Activation Failure; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN ATTEMPT TO INFLATE THE BALLOON OF A 4.00X12MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) WAS MADE TWICE, AND BOTH TIMES ONLY REACHED 2 ATMOSPHERES. DURING REMOVAL OF THE XIENCE SKYPOINT PARTIALLY DEFLATED BALLOON, RESISTANCE WAS MET WITH ANATOMY AND THE STENT CAME OFF THE SHAFT. AN UNSPECIFIED BALLOON WAS USED TO DEPLOY THE DISLODGED STENT IN THE RADIAL ARTERY. A 4.00X12MM NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 21943862 ↗
• MalfunctionMar 17, 2025Break; Off-Label Use; Failure to Advance; Material Deformation; Break; Off-Label Use; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A STROKE ALERT AND A DISSECTION IN THE LEFT CAROTID ARTERY. A TOTAL OF 9 XIENCE SKYPOINT STENTS WERE ATTEMPTED TO BE USED IN THE PROCEDURE. 5 XIENCE SKYPOINT STENTS WERE IMPLANTED WITHOUT ISSUE; HOWEVER, 4 XIENCE SKYPOINT STENTS WERE INTRODUCED IN TO THE PATIENT, BUT THE THE STENTS BECAME CRUSHED AND FRAYED (BROKEN). THEREFORE, THE 4 XIENCE SKYPOINT STENTS WERE REMOVED FROM 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 21623905 ↗
• MalfunctionOct 17, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 4.0X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) BALLOON WAS WAS ADVANCED WITH RESISTANCE NOTED WITH THE ANATOMY AND WAS PREPPED INSIDE THE ANATOMY. THE SDS BALLOON WAS INFLATED ONCE FOR DEPLOYMENT; HOWEVER, THE BALLOON RUPTURED AS THE BALLOON STOPPED INCREASING DURING INFLATION. THE STENT WAS REMOVED ON THE BALLOON OF THE DEVICE. A NEW XIENCE SKYPOINT SDS WAS USED TO CONTINUE 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 20473201 ↗
• InjurySep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). REPORTEDLY A 4.0X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED INTO THE ANATOMY; HOWEVER, IT WAS NOTED THAT THE STENT DISLODGED FROM THE BALLOON OUTSIDE OF THE GUIDING CATHETER. THE DISLODGED STENT WAS REMOVED WITH A SNARE DEVICE. A 4.0X38 MM XIENCE SKYPOINT DES WAS IMPLANTED 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 20179229 ↗
• MalfunctionMay 1, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 75% STENOSIS. DURING NEGATIVE PRESSURE TEST OUTSIDE THE ANATOMY, THE 4.0X12MM XIENCE SKYPOINT STENT DELIVERY STENT (SDS) WAS OBSERVED TO HAVE A PINHOLE LEAK AROUND THE BALLOON CENTER. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT 4.00×12 STENT 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 19222914 ↗
• MalfunctionApr 12, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT PRIOR TO USE THE 4.0X12MM XIENCE SKYPOINT STENT APPEARED TO BE LARGER IN SIZE THAN USUAL AND WAS NOT USED. ANOTHER XIENCE STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098419 ↗
• MalfunctionJan 17, 2024Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE PROXIMAL LEFT MAIN ARTERY WITH MODERATE CALCIFICATION. THE 4.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT WITH THE GUIDE WIRE. UPON REMOVAL, THE TIP OF THE DELIVERY SYSTEM SNAGGED ON THE GUIDE WIRE AND THE TIP SEPARATED FALLING OFF OUTSIDE THE ANATOMY. ANOTHER 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 18527917 ↗
• MalfunctionSep 15, 2023Difficult 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 LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY HEAVILY CALCIFIED AND TORTUOUS IN THE LEFT MAIN TO PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 4.00X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT MET RESISTANCE, SO THE SDS WAS REMOVED FOR ADDITIONAL PRE-DILATATION. RESISTANCE WAS ALSO OBSERVED DURING REMOVAL OF THE SDS. WHEN REMOVED FROM THE ANATOMY, THE STENT EDGE WAS NOTED TO BE FLARED. AFTER PERFORMING PRE-DILATION, ANOTHER STENT WAS DEPLOYED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761367 ↗
• MalfunctionApr 10, 2023Difficult 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 90% STENOSED DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 4.00X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCE TO THE TARGET LESION HOWEVER; FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, SDS WAS REMOVED FROM ANATOMY AND DIFFICULTY WAS ALSO NOTED DUE TO THE ANATOMY. THE STENT WAS NOTED TO BE FLARED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710003 ↗
• MalfunctionFeb 1, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 4.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND ATTEMPTED TO DEPLOY THE STENT, HOWEVER, THE STENT FAILED TO DEPLOY. THE SDS WAS REMOVED WITHOUT DIFFICULTY AND THE STENT REMAINED ON THE DELIVERY SYSTEM. ANOTHER SAME SIZE XIENCE SKYPOINT SDS 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 16278119 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF ST ELEVATION MYOCARDIAL INFARCTION (STEMI). ON (B)(6) 2022, A 4.0X12MM XIENCE SKYPOINT STENT WAS IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL FOR CHEST PAIN. NO TREATMENT WAS PROVIDED AND THERE WAS NO ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED ON (B)(6) 2022. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 15396896 ↗
• InjuryAug 16, 2022Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 4X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION; HOWEVER, DURING DEPLOYMENT, THE BALLOON RUPTURED AND THE STENT WAS ONLY PARTIALLY DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER BALLOON WAS USED TO FULLY DEPLOY AND IMPLANT THE STENT, AND COMPLETE THE PROCEDURE. 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 15237907 ↗
• MalfunctionAug 2, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) AND THE DISTAL RCA. THE PATIENT HAD TWO UNSPECIFIED XIENCE SKYPOINT STENTS IMPLANTED IN (B)(6) 2022. A 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE BETWEEN THE TWO STENTS. SLOW DEFLATION OF THE BDC WAS NOTED, BUT HAD NO FURTHER ISSUES AND WAS REMOVED SUCCESSFULLY. OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THERE WAS A GAP BETWEEN THE TWO PREVIOUSLY IMPLANTED STENTS AND A 4.0X12MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY WITH SLOW DEFLATION OF THE DEVICE NOTED; HOWEVER, THE STENT DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY. A 4.0X38MM XIENCE SKYPOINT STENT WAS ATTEMPTED TO BE IMPLANTED PROXIMALLY FROM THE PREVIOUSLY IMPLANTED XIENCE SKYPOINT IN (B)(6); HOWEVER, FAILED TO BE IMPLANTED AS INTERACTION WITH THE PREVIOUSLY IMPLANTED STENT WAS FELT. THE 3.5X20MM TREK BALLOON DILATATION CATHETER WAS ADVANCED, THEN INFLATED TWICE TO 12 AND 10 ATMOSPHERES. THE PHYSICIAN ATTEMPTED THREE TIMES TO PULL NEGATIVE, BUT THE BDC WOULD NOT DEFLATE. IT WAS DECIDED TO REMOVE THE BDC WITH THE ENTIRE SYSTEM AS ONE UNIT. DURING REMOVAL THE SHAFT SEPARATED AND BECAME LODGED IN THE ELBOW AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154185 ↗
• InjuryJun 22, 2022Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY TORTUOUS AND CALCIFIED MID TO DISTAL RIGHT CORONARY ARTERY (RCA). THE FIRST XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION DUE TO THE PATIENT ANATOMY. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY AND A SECOND XIENCE SKYPONT WAS USED. THE SECOND XIENCE SKYPOINT WAS ADVANCED; HOWEVER, THIS ONE WAS ALSO UNABLE TO CROSS DUE TO THE PATIENT ANATOMY AND THE PROXIMAL SHAFT KINKED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, BUT SEPARATED AT THE KINK, AT A LOCATION OUTSIDE THE PATIENT ANATOMY. BOTH SEPARATED SEGMENTS WERE EASILY REMOVED FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 14782446 ↗
• MalfunctionMay 4, 2022Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. PRE-DILATATION WAS PERFORMED AND THE 4.00X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, COULD NOT CROSS THE LESION DUE TO THE ANATOMY. DESPITE THE SDS BEING REMOVED FOR ADDITIONAL DILATATION AND REATTEMPTED TO REACH THE TARGET LESION, THE SDS STILL COULD NOT REACH DUE TO ANATOMY. THEREFORE, THE SDS WAS REMOVED AND RESISTANCE WAS NOTED DURING REMOVAL DUE TO ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT OR NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE TARGET LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14282396 ↗
• MalfunctionMay 4, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 4.00X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO ADVANCE TO THE TARGET LESION DUE TO ANATOMICAL CHALLENGES. THEREFORE, SDS WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED DURING REMOVAL DUE TO ANATOMICAL CHALLENGES. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14273361 ↗
• MalfunctionApr 21, 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, 99% STENOSED, DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA). A 4X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177612 ↗
• MalfunctionApr 19, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY THAT IS 50% STENOSED. THE 4.0X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL OF THE SDS RESISTANCE WAS FELT WITH ANATOMY. 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 14142143 ↗
• MalfunctionJan 17, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% STENOSED, CONCENTRIC, MILDLY CALCIFIED, TORTUOUS RIGHT CORONARY ARTERY. DURING PREPARATION OF THE 4.0X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) THERE WAS DIFFICULTY REMOVING THE PROTECTIVE SHEATH. ADDITIONALLY THE STENT WAS NOTED TO HAVE MOVED ON THE BALLOON. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. A 4.0X15 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. 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 13266810 ↗
• MalfunctionAug 18, 2021Difficult 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, HEAVILY TORTUOUS, 90% STENOSED RIGHT CORONARY ARTERY. A 4X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND FACED RESISTANCE DURING REMOVAL WITH THE ANATOMY. AN UNSPECIFIED BALLOON 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 12336492 ↗