XIENCE Skypoint™ 1804225-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08717648232992), received between Apr 5, 2021 and May 3, 2024 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (16 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT, WITH A HISTORY OF CHRONIC ISCHEMIC HEART DISEASE AND ST ELEVATION MYOCARDIAL INFARCTION (STEMI), HAD TWO XIENCE SKYPOINT (2.25.X15 AND 2.25X28 MM) STENTS IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE AND THROMBOSIS OF THE STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19243003 ↗
• MalfunctionDec 24, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION AS THE NON-ABBOTT GUIDE WIRE WRAPPED AROUND THE STENT PREVENTING IT FROM ADVANCING. BOTH SDS AND GUIDE WIRE WERE REMOVED. THE STENT WAS NOTED TO BE BENT. ANOTHER 2.25X16MM 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 18389995 ↗
• InjuryNov 17, 2023Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. PRE-DILATATION WAS PERFORMED WITH A 2.25 TREK BALLOON. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED BUT IT COULD NOT REACH THE LESION DUE TO THE ANATOMY SO A 6FR NON-ABBOTT GUIDE CATHETER EXTENSION WAS USED TO ASSIST THE DEVICE IN REACHING THE LESION. THE DEVICE WAS THEN PULLED BACK TO TRY AND DILATE THE AREA MORE BUT THERE WAS RESISTANCE WITH THE CALCIUM AND THE STENT DISLODGED FROM THE DELIVERY SYSTEM. A BALLOON WAS ADVANCED TO THE STENT AND DEPLOYED THE STENT IN AN AREA WHICH WAS PLANNED TO BE STENTED IN THE SAME PROCEDURE. TWO OTHER XIENCE SKYPOINT STENTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. 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 18164917 ↗
• MalfunctionJul 31, 2023Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PULLED FROM THE DISPENSER HOOP WITHOUT RESISTANCE. THERE WAS NO RESISTANCE DURING REMOVAL OF THE STYLET AND THERE WAS NO RESISTANCE DURING REMOVAL OF THE PROTECTIVE SHEATH. THE SDS WAS NOT PREPARED PER INSTRUCTIONS FOR USE (IFU) AND PRIOR TO ENTERING THE ANATOMY, THE STENT WAS NOTED TO BE DISLODGED. UNKNOWN EXACTLY WHEN THE STENT DISLODGEMENT OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17426290 ↗
• MalfunctionJul 11, 2023Difficult 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 LESION IN THE LEFT CIRCUMFLEX (CX) ARTERY. A 2.25X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, IT COULD NOT CROSS THE DIFFICULT ANATOMY TO BE IMPLANTED. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT STENT 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 17302134 ↗
• MalfunctionMay 12, 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 MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, FAILED TO ADVANCE DUE TO THE ANATOMY. THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND DIFFICULTY WAS ALSO NOTED DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT REPORTED IN THE PROCEDURE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924333 ↗
• MalfunctionMay 10, 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 MILDLY CALCIFIED, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.25X15 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. A NON-ABBOTT STENT WAS USED TO CONTINUE 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 16905260 ↗
• InjuryMar 24, 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 LESIONS IN THE IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY AND PROXIMAL RAMUS INTERMEDIUS (PRI) CORONARY ARTERY. ACTIVATED CLOTTING TIME (ACT) WAS NOTED TO BE 303 SECONDS; THEREFORE, ANOTHER 2000 UNITS OF IV HEPARIN WERE ADMINISTERED. ADDITIONALLY, 180MG OF BRILINTA WAS ADMINISTERED. THE 3.25X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION IN THE PLAD AND THE STENT WAS DEPLOYED AT 18 ATM FOR 12 SECONDS. ANGIOGRAPHY WAS PERFORMED AND THERE WAS NO ISSUE WITH THE IMPLANTED STENT. NEXT THE 2.25X15MM XIENCE SKYPOINT SDS WAS ADVANCED TO THE TARGET LESION IN THE PRI AND DEPLOYED AT 12 ATM FOR 15 SECONDS. THE PHYSICIAN TOOK ANGIOGRAPHIC VIEWS POST STENT IMPLANTATION. THERE WAS NO REPORTED ISSUE WITH THE SECOND IMPLANTED STENT. POST PROCEDURE THE PATIENT NOTED CHEST PAIN OF A 2 ON A SCALE OF 10. SOMETIME POST PROCEDURE IN THE HOLDING AREA, BLOOD PRESSURE WAS NOTED TO BE CRITICALLY LOW AND THE PATIENT WAS DIAPHORETIC WITH SEVERE CHEST PAIN. ELECTROCARDIOGRAM (EKG/ECG) NOTED AN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS BROUGHT BACK, EMERGENTLY, TO THE CATH LAB. AT SOME POINT, THE PA

  Patient problems: Angina; Cardiac Arrest; Diaphoresis; Low Blood Pressure/ Hypotension; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 16613504 ↗
• MalfunctionMar 23, 2023Difficult 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, 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 2.25X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, IT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16602406 ↗
• MalfunctionFeb 28, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, HEAVILY TORTUOUS CIRCUMFLEX ARTERY. THE 2.25X15MM XIENCE SKYPOINT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED DUE TO ANATOMY. THE DEVICE WAS REMOVED AND THE LESION WAS BALLOONED. A SECOND ATTEMPT WAS MADE TO ADVANCE THE SDS, BUT AGAIN FAILED. THE DEVICE WAS REMOVED AND AN EXTENSION GUIDE CATHETER WAS ADVANCED. THE SDS WOULD NOT ADVANCE OR RETRACT FROM WITHIN THE GUIDE EXTENSION CATHETER; THEREFORE, BOTH WERE REMOVED AS A SINGLE UNIT. IT WAS NOTED THAT THE STENT NO LONGER REMAINED ON THE SDS; HOWEVER WAS REMOVED WITH THE ENTIRE UNIT. THEN A 2.5X23MM AND 3.25X15MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. A FOURTH STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455833 ↗
• InjuryFeb 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY. THE 2.25X15MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED INTO THE RIGHT CORONARY ARTERY (RCA) THROUGH AN EXISTING STENT, BUT CAUGHT ON THE IMPLANTED STENT AND DISLODGED. ANOTHER STENT WAS ADVANCED AND IMPLANTED, CRUSHING THE DISLODGED STENT INTO THE VESSEL WALL. BALLOON ANGIOPLASTY WAS USED TO TREAT THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16309356 ↗
• MalfunctionJan 10, 2023Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN THE CIRCUMFLEX (CX) ARTERY. A 2.25X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) FAILED TO CROSS THE LESION DUE TO ANATOMICAL CONDITIONS AND A DISSECTION WAS NOTED. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 16134966 ↗
• InjuryNov 18, 2022Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  ON (B)(6) 2022 I SUFFERED A HEART ATTACK. DR. (B)(6) ATTEMPTED TO PLACE A STENT IN THE MID LAD. THE STENT WOULD NOT COME OFF THE BALLOON POST FULL DEPLOYMENT, THE STENT HAD TO BE DEPLOYED IN THE LEFT MAIN WHERE IT GOT STUCK. DUE TO DAMAGE CAUSED BY THE STENT BEING STUCK ON THE BALLOON AND PULLED BACK, I SUFFERED ANOTHER MORE SERIOUS HEART ATTACK ON (B)(6) 2022 THAT LEAD TO AN EMERGENCY DOUBLE BYPASS SURGERY ON (B)(6) 2022. THE FAILURE OF THE STENT CAUSED A SECOND HEART ATTACK AND DOUBLE BYPASS. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Myocardial Infarction

  MAUDE report 15834394 ↗
• MalfunctionOct 11, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SKYPOINT WOULD NOT ADVANCE THROUGH THE BLEEDBACK CONTROL VALVE OF THE CO-PILOT AND THE STENT DISLODGED IN THE GUIDE CATHETER. EVERYTHING WAS EASILY REMOVED FROM THE GUIDING CATHETER WITH NO ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574654 ↗
• InjuryAug 29, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, LESION IN THE DIAGONAL ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND SHOCKWAVE WAS PERFORMED. SUBSEQUENTLY, RE-WIRING WAS PERFORMED AND A 2.25X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BEHIND THE PROXIMAL LAD; HOWEVER, THE STENT COULD NOT CROSS THE PREVIOUSLY IMPLANTED STENT. SOME FORCE WAS APPLIED, AND THE STENT BECAME DETACHED FROM THE DELIVERY SYSTEM. THE STENT BECAME A FOREIGN BODY SOMEWHERE IN THE PATIENT ANATOMY. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT WITH A WIRE, BUT IT COULD NOT BE RETRIEVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE DISLODGED STENT WAS CRUSHED TO THE WALL OF THE LAD BY ANOTHER STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15317373 ↗
• MalfunctionAug 10, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT PRIOR TO USE AND DURING INSPECTION OF A 2.25X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) A BREAK WAS OBSERVED ON THE PROXIMAL HUB OF THE SDS. THE SDS WAS NOT USED IN 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 15204173 ↗
• MalfunctionAug 4, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND SUCCESSFULLY DEPLOYED; HOWEVER, THE SDS BALLOON FAILED TO DEFLATE COMPLETELY. NEGATIVE PRESSURE WAS HELD FOR APPROXIMATELY 2 MINUTES; HOWEVER THE BALLOON ONLY PARTIALLY DEFLATE. THE SDS WAS REMOVED WITH DIFFICULTY 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 15170938 ↗
• InjuryJul 1, 2022Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST DIAGONAL BRANCH ARTERY. THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS TRYING TO CROSS A PREVIOUSLY DEPLOYED STENT IN THE LEFT ANTERIOR DESCENDING (LAD) BUT COULD NOT GO THROUGH. UPON REMOVAL, THE XIENCE SKYPOINT STENT GOT SNAGGED WITH THE PREVIOUSLY DEPLOYED STENT. SINCE THE LAD WAS BYPASSED, A SERIES OF BALLOONS WERE USED TO INFLATE THE STENT IN THE LAD. THE PATIENT IS OKAY, HOWEVER, THERE WAS A DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14886402 ↗
• 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 100% STENOSED DIAGONAL ARTERY. THE 2.25 X 15 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 NO 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 14837365 ↗
• MalfunctionApr 27, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE RIGHT POSTERIOR ATRIO-VENTRICULAR ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. THE XIENCE SKYPOINT DES 2.25 X 15 RX STENT DELIVERY SYSTEM FAILED TO CROSS AND THERE WAS RESISTANCE DURING REMOVAL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT STENT WAS APPLIED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222596 ↗
• InjuryMar 15, 2022Difficult to Remove; Activation Failure; Difficult to Remove; Activation Failure

  IT WAS REPORTED THAT ON (B)(6) 2022, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE BALANCE MIDDLE WEIGHT WAS SUCCESSFULLY PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. VASOSPASMS OCCURRED FOLLOWING, TREATED WITH ROUTINE MEDICATIONS. THE VASOSPASMS RESOLVED WITHOUT ANY SERIOUS ADVERSE EVENT ASSOCIATED. FOLLOWING, PRE-DILATATION WAS SUCCESSFULLY PERFORMED USING A 2.0X8MM TREK AND A SKYPOINT STENT DELIVERY SYSTEM (SDS) ADVANCED TO THE MID LAD. DEPLOYMENT WAS ATTEMPTED VIA BALLOON INFLATION USING THE STENT DELIVERY SYSTEM. IT WAS THOUGHT THAT THE STENT DEPLOYED; HOWEVER, DURING SDS RETRACTION, THE STENT REMAINED ON THE BALLOON, AND WAS PULLED WITH THE DELIVERY SYSTEM INTO THE LEFT MAIN (LM). THERE WAS NO INFLATION ISSUE NOTED; HOWEVER, THE STENT STAYED ON THE BALLOON CATHETER. THEY WERE UNABLE TO RETRACT THE STENT INTO THE GUIDE CATHETER AND SO IT WAS DECIDED TO DEPLOY THE STENT IN AN UNINTENDED AREA OF THE LM. FOR ADEQUATE WALL APPOSITION, ANOTHER BALLOON CATHETER (3.5X12MM TREK) ADVANCED AND APPOSED THE SKYPOINT STENT TO THE LM VESSEL WALL. HEPARIN WAS PROVIDED THROUGHOUT THE PROCEDURE PER PROTOCOL. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINI

  Patient problems: Foreign Body In Patient; Myocardial Infarction

  MAUDE report 13764924 ↗
• InjuryFeb 14, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH ADVANCED DISEASE. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH SLIGHT RESISTANCE NOTED BUT IT WAS NOTED THAT THE STENT WAS NOT SEEN ON THE DELIVERY SYSTEM AND THE STENT WAS SEEN FLOATING IN THE OBTUSE MARGINAL ARTERY. A MINI TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND INFLATED SLIGHTLY IN ORDER TO MOVE THE STENT TO THE INDENTED LOCATION AND THE STENT WAS DEPLOYED WITH ADDITIONAL DILATATIONS. A DISSECTION WAS NOTED DISTALLY AND 10 XIENCE STENTS WERE LAYERED TO TREAT THE DISSECTION. TEN XIENCE STENTS WERE REQUIRED DUE TO ADVANCED DISEASE STATE IN THE RCA, INCLUDING NUMEROUS RUPTURED PLAQUES AND STENOSED AREAS COMBINED WITH DIFFICULT, CALCIFIED, TORTUOUS ANATOMY REQUIRED SHORTER STENTS TO DELIVER FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 13524693 ↗
• MalfunctionJan 4, 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 RIGHT POSTERIOR ATRIO-VENTRICULAR ARTERY. THE 2.25X15MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE DEVICE. A 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 13154415 ↗
• MalfunctionDec 20, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS AND 100% STENOSED RIGHT POSTERIOR ATRIO-VENTRICULAR ARTERY. DURING ADVANCEMENT OF A XIENCE SKYPOINT 2.25X15 DRUG ELUTING STENT (DES), IT WAS OBSERVED DURING ADVANCEMENT, THE STENT MOVED BUT REMAINS TIGHTLY CRIMPED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER XIENCE 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 13044355 ↗
• MalfunctionDec 9, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED LESION IN THE DIAGONAL CORONARY ARTERY. A 2.25X15MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) FAILED TO CROSS THE ANATOMY TO REACH THE TARGET LESION. UPON REMOVAL OF THE DEVICE, RESISTANCE WAS MET WITH THE ANATOMY. A NON-ABBOTT STENT WAS ABLE TO CROSS TO SUCCESSFULLY 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 12973192 ↗