XIENCE Skypoint™ 1804225-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08717648232985), received between Feb 23, 2021 and Apr 13, 2026 — classified as 13 injuries, 11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE OBTUSE MARGINAL ARTERY. THE 2.25X12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER THE STENT DISLODGED FROM THE BALLOON. THE GUIDELINER AND GUIDE WIRE WERE REMOVED WITH THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 24859323 ↗
• InjuryDec 22, 2025Failure to Advance; Failure to Advance

  SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS REPORTED THAT THERE WAS NO DISSECTION AND THAT XIENCE SKYPOINT DRUG-ELUTING STENT (DES) FAILED TO CROSS DUE TO ANATOMY (CALCIFIED LESION). A NON-ABBOTT DES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 23872972 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI) HAD FOUR XIENCE SKYPOINT (2.25X12, 2.5X18, 2.5X38, 3.5X38MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE AND STEMI AT WHICH TIME, A FIFTH, 2.5X15 MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2025 THE PATIENT WAS RE-ADMITTED AGAIN ON (B)(6) 2025 WITH CHRONIC ISCHEMIC HEART DISEASE AND CHEST PAIN. NO ADDITIONAL TREATMENT WAS PERFORMED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 21962383 ↗
• MalfunctionApr 21, 2025Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DIAGONAL CORONARY ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. THE 2.25X12 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED BUT THE BALLOON PARTIALLY INFLATED BEFORE IT RUPTURED AND THE STENT FAILED TO DEPLOY. THE STENT WAS REMOVED ON THE DELIVERY SYSTEM AND A NON-ABBOTT DEVICE 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 21877000 ↗
• MalfunctionDec 10, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL ARTERIES. AFTER PRE-DILATATION WITH A NON-ABBOTT BALLOON, THE 2.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE BIFURCATION OF THE LAD; THEN THE NON-ABBOTT BALLOON WAS REMOVED. A 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS THEN ATTEMPTED TO BE ADVANCE TO THE FIRST DIAGONAL; HOWEVER, THE SDS BECAME STUCK IN THE GUIDE CATHETER. THEREFORE, THE GUIDE WIRE, SDS AND BDC WERE REMOVED WITH RESISTANCE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20888929 ↗
• InjuryJun 13, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA) WITH HEAVY CALCIFICATION. THE 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT INITIALLY STATED AS FAILED TO DEPLOY. THE BALLOON WAS DEFLATED AND IT WAS NOTED THAT THERE WAS NO STENT AND THE STENT WAS FOUND IN THE PROTECTIVE SHEATH. HOWEVER, THE PATIENT SUFFERED A DISSECTION WITH SOME CONTRAST FLOWING OUTSIDE THE ARTERY. IT WAS CONTAINED. THE PATIENT WILL BE BROUGHT BACK AND MAKE ANOTHER ATTEMPT TO COMPLETE THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, UPDATE TO EVENT OR PROBLEM: THE DISSECTION WAS NOT TREATED BUT WAS CONTAINED.

  Patient problems: Vascular Dissection

  MAUDE report 19533846 ↗
• InjuryApr 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS FIRST DIAGONAL BRANCH. THE 2.25X12MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE; HOWEVER, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN, WHICH WAS CONFIRMED WITH POSITIVE EKG. ANGIOGRAPHY WAS PERFORMED AND OBSERVED ACUTE THROMBUS HAD OCCURRED. THE STENT WAS BALLOONED AND THROMBECTOMY WAS PERFORMED ON THE DIAGONAL LESION. IT WAS NOTED THAT THE CORRECT STENT SIZE WAS SELECTED; HOWEVER, MAY HAVE BEEN NOT BEEN FULLY APPOSED TO VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 19033448 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 2.75X23 MM XIENCE SKYPOINT STENT AND A 2.25X12 MM XIENCE SKYPOINT STENT WERE IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD TORTUOSITY AND 75% STENOSIS ON (B)(6) 2023 AND THEN THE FOLLOWING SYMPTOMS BEGAN 2 WEEKS LATER: PERSISTENT URTICARIA AND ANGIOEDEMA EFFECTING FACE, NECK, BACK, CHEST, ARMS. ANTIHISTAMINES WERE PROVIDED; HOWEVER, THE REACTION IS STILL PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 19015067 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEDWATCH WAS RECEIVED WHICH STATES:HAD TWO CARDIAC STENTS IMPLANTED ON (B)(6) 2023, BY DR. (B)(6) AT (B)(6) HOSPITAL. THE DESCRIPTION OF STENTSIS AS FOLLOWS: STENT XIENCE SKYPOINT 2.75MMX23MM RAPID EXCHANGE EVEROLIMUS ELUTING CORONARY,MANUFACTURER ABBOTT LABORATORIES. MODEL NUMBER 1804275-23; LOT NUMBER 110184B; DESCRIPTION LAD 2(LEFT ANTERIOR DESCENDING, TYPE 2); STENT XIENCE SKYPOINT 2.25MMX12MMRAPID EXCHANGE EVEROLIMUSELUTING CORONARY, MANUFACTURER ABBOTT LABORATORIES. MODEL NUMBER 1804225-12; LOT NUMBER 3011941;DESCRIPTION LAD (LEFT ANTERIOR DESCENDING). A FEW DAYS AFTER THE PROCEDURE, I STARTED GETTINGSWELLING ON MY SCALP. THE SWELLING THEN PROGRESSIVELY EXTENDED TO EYES, FACE, EARS, NECK, CHEST, ANDHAND, AND TO LESS EXTENT ON OTHER PARTS OF THE BODY. I ALSO FEEL SWELLING IN INTERNAL ORGANS LIKE HEARTAND LUNGS, ETC. LATER, I STARTED GETTING HEADACHE, PAIN IN MY BACK AND WAIST AS WELL. I VISITED THE ER(EMERGENCY ROOM) AT (B)(6) ON (B)(6) 2023, WITH SEVERE SWELLING ON MY SCALP, FACE, EYES AND SHOULDERS. IWAS PRESCRIBED PREDNISONE, DIPHENHYDRAMINE AND AMOXICILLIN-CLAVULANATE. I WAS ADVISED TO MEET WITHMY CARDIOLOGIST AND ALLERGY SPECIALIST WHICH I DID. AFTER COMPLETING THE COUR

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

  MAUDE report 18485741 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A TARGET LESION IN THE CIRCUMFLEX (CX) ARTERY. THE PATIENT ANATOMY INCLUDED 1 UNSPECIFIED STENT, IMPLANTED APPROXIMATELY 8 MONTHS AGO IN THE LEFT MAIN, AND EXTENDING INTO THE OSTIUM OF THE CX ARTERY. A 3.5 X 15 MM XIENCE SKYPOINT WAS IMPLANTED IN THE CX, A 2.25 X 12 MM XIENCE SKYPOINT WAS IMPLANTED IN THE MID CX AND A 2.5 X 15 MM XIENCE SKYPOINT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. IT WAS NOTED THAT A POSSIBLE DISSECTION HAD OCCURRED AT THE PROXIMAL CX; THEREFORE, A 2.25 X 8 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE CX ARTERY, TO TREAT THE DISSECTION. THE XIENCE SKYPOINT WAS ADVANCED TO THE TARGET SITE; HOWEVER, DUE TO INTERACTION WITH THE PREVIOUSLY IMPLANTED LEFT MAIN STENT, THE XIENCE SKYPOINT STENT WAS UNABLE TO CROSS. DURING REMOVAL, THE XIENCE SKYPOINT STENT CAUGHT ON THE LEFT MAIN STENT AND DISLODGED. THERE WERE NO ATTEMPTS TO REMOVE THE DISLODGED STENT, AND THE STENT WAS CRUSHED TO THE VESSEL WALL. AS THE DISSECTION WAS UNABLE TO BE CONFIRMED, NO ADDITIONAL INTERVENTION WAS PERFORMED TO TREAT THE POSSIBLE DISSECTION. THE PROCEDURE ENDED WITH THE PATIENT IN STABLE CONDITION. NO ADDI

  Patient problems: Vascular Dissection

  MAUDE report 17148438 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT, WITH A HISTORY OF ST ELEVATION MYOCARDIAL INFARCTION AT THE INFERIOR WALL OF A CORONARY ARTERY AND CORONARY ARTERY DISEASE, HAD 1 XIENCE SKYPOINT (2.25X12MM) STENT IMPLANTED. ON (B)(6) 2023, THE PATIENT WAS RE-HOSPITALIZED WITH CHRONIC ISCHEMIC HEART DISEASE, ST ELEVATION MYOCARDIAL INFARCTION AND THROMBOSED STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED AND THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2023. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 16932121 ↗
• InjuryApr 18, 2023Improper or Incorrect Procedure or Method; Defective Device; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIRST PROCEDURE WAS PERFORMED ON (B)(6) 2023 TO TREAT A LESION WITH FOUR XIENCE SKYPOINT STENT DELIVERY SYSTEMS (SDS). A 2.5X23 MM AND 2.25X12 MM XIENCE SKYPOINT STENT WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD), ONE ON THE CIRCUMFLEX (CX), AND THE LAST ONE ON THE RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS DISCHARGED ON 1/06/23 WITH PLAVEX. ON THE (B)(6) 2023 THE PATIENT EXPERIENCED CHEST PAIN AND WAS DIAGNOSED WITH ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE LAD WAS FOUND TO BE UNDER TOTAL THROMBOTIC OCCLUSION WITH IN STENT RESTENOSIS IN THE OSTIAL,PROXIMAL, MID AND DISTAL LAD WITH 100% STENOSIS. AFTER PRE DILATING THE LESION WITH A 3.25 NON-COMPLIANT BALLOON (NC) TO THE PROXIMAL AND DISTAL STENT IN THE MID LAD AND A 3.00MM NON-COMPLIANT BALLOON (NC) IN THE DISTAL LAD. A 2.75X28 XIENCE SKYPOINT SDS WAS IMPLANTED IN MID LAD, DISTAL TO THE PREVIOUSLY IMPLANTED STENT. REPORTEDLY, THE STENTS WERE UNDERSIZED TO THE VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 16765578 ↗
• MalfunctionMar 28, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT AND FAILED TO CROSS DUE TO THE ANATOMY. THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. THE SDS WAS REMOVED INDEPENDENTLY. THERE WERE NO OTHER DEVICE ISSUES NOTED. 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 16628894 ↗
• MalfunctionSep 12, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE HEAVILY TORTUOUS, HEAVILY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILURE TO CROSS DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY. A NON-ABBOTT DEVICE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405901 ↗
• InjuryApr 20, 2022Adverse 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 RIGHT POSTERIOR ATRIO-VENTRICULAR AND RIGHT POSTERIOR DESCENDING LESIONS ON (B)(6) 2021. PRE-DILATATION WAS PERFORMED WITH SEMI-COMPLIANT BALLOON. A 2.25X18MM XIENCE SKYPOINT WAS DEPLOYED AT 10 ATMOSPHERES WITHOUT POST DILATATION. THEN A 2.25X12MM XIENCE SKYPOINT WAS DEPLOYED AT 16 ATMOSPHERES WITH POST DILIATATION. NO ISSUE WAS NOTED DURING THE PROCEDURE. ON (B)(6) 2021 AND (B)(6) 2022, THE PATIENT CAME TO THE HOSPITAL BUT NO ISSUE WAS NOTED ON THE PATIENT'S CONDITION DURING THOSE VISITS. ON (B)(6) 2022, THE PATIENT DIED. RELATION BETWEEN THE INCIDENT AND THE STUDY IS NOT DETERMINED. PER THE PHYSICIANS CLINICAL DECISION THE CAUSE OF DEATH WAS DUE TO ACUTE MYOCARDIAL INFARCTION. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ANGIOGRAPHY WAS PERFORMED. PRESCRIBED ANTI-PLATELET DRUGS(CLOPIDOGREL, ASPIRIN) WERE STOPPED BEING APPLIED BY THE TIME THE PATIENT WAS RELEASED FROM HOSPITAL AFTER PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. NO ADDITIONAL INFORMATION.

  Patient problems: Myocardial Infarction

  MAUDE report 14160995 ↗
• InjuryApr 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DIAGONAL BRANCH OFF THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25X12M XIENCE SKYPOINT WAS ADVANCED TO THE LESION WITHOUT ISSUE AND WHEN POSITIONING FOR DEPLOYMENT, THE STENT IMPLANT DISLODGED. THE STENT IMPLANT WAS BALLOONED AND EMBEDDED IN THE VESSEL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14030661 ↗
• InjuryMar 31, 2022Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE XIENCE SKYPOINT DES 2.25 X 12 RX STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS AND DURING REMOVAL OF THE SDS WITH RESISTANCE, THE STENT CAME OFF THE DELIVERY SYSTEM BALLOON IN THE LEFT MAIN (LM), WHICH WAS NOT THE INTENDED VESSEL. WHILE THE DISLODGED STENT WAS IN THE LM, A BALLOON CATHETER WAS ADVANCED AND THREADED INTO THE DISLODGED STENT. THE STENT WAS THEN IMPLANTED IN THE LM. THERE WAS NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAY REPORTED. A SAME SIZE STENT WAS THEN IMPLANTED IN THE INTENDED LESION IN THE LAD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13958496 ↗
• MalfunctionMar 14, 2022Leak/Splash; Improper or Incorrect Procedure or Method; Activation Failure; Leak/Splash; Improper or Incorrect Procedure or Method; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST OBTUSE MARGINAL ARTERY. AN UNSPECIFIED GUIDE WIRE CROSSED AND A 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO INFLATE. ONCE REMOVED THE SDS WAS FLUSHED WITH SALINE AND A LEAK WAS NOTED AROUND THE PROXIMAL STENT EDGE. ANOTHER 2.25X12MM XIENCE SKYPOINT 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 13760530 ↗
• MalfunctionDec 29, 2021Difficult 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 DISTAL RIGHT CORONARY ARTERY (DRCA). AFTER DILATATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON, A 2.25X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO REACH THE TARGET LESION DUE TO THE ANATOMY. AN EXTENSION CATHETER WAS THEN INSERTED; HOWEVER, THE DES STILL COULD NOT CROSS THE ANATOMY. THE DEVICE WAS REMOVED WITH RESISTANCE FROM THE ANATOMY AND A BALLOON DILATATION CATHETER WAS USED FOR DILATATION OF THE LESION 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 13111001 ↗
• MalfunctionDec 3, 2021Difficult 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 100% STENOSED LESION IN THE FIRST DIAGONAL ARTERY. A 2.25X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY AND FAILED TO REACH THE TARGET LESION. THE DES WAS REMOVED WITH RESISTANCE AND A NON-ABBOTT DEVICE WAS USED 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 12929777 ↗
• MalfunctionSep 23, 2021Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND MODERATELY LEFT ANTERIOR DESCENDING ARTERY. A XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS INSERTED, BUT DUE TO THE ANATOMY, THE DEVICE WAS UNABLE TO CROSS THE LESION. IT WAS NOTED THAT RESISTANCE WAS FELT DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. A NON-ABBOTT DEVICE WAS THEN USED TO PERFORM 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 12518999 ↗
• MalfunctionAug 6, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY (PLCX). TWO XIENCE SKYPOINT STENT DELIVERY SYSTEMS WERE ADVANCED AT THE SAME TIME INSIDE THE GUIDING CATHETER (GC); HOWEVER, THE DEVICES BECAME STUCK DURING ADVANCEMENT AND WERE DIFFICULT TO REMOVE FROM THE GC. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289427 ↗
• MalfunctionApr 5, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY INTO THE 1ST DIAGONAL WITH A VESSEL DIAMETER OF 2.4MM AND A LESION LENGTH OF 10MM. THE 2.25X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED USING A GUIDE EXTENSION CATHETER BUT FAILED TO CROSS THE TORTUOSITY AT THE PROXIMAL END OF THE TARGET LESION. RESISTANCE WAS THEN MET DURING REMOVAL OF THE SDS DUE TO THE ANATOMY. THE SDS WAS REPLACED WITH A NON-ABBOTT SDS TO SUCCESSFULLY COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THE FAILURE TO CROSS WITH THE XIENCE SKYPOINT WAS DUE TO THE PRODUCT DELIVERY PERFORMANCE. 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 11613349 ↗
• InjuryFeb 23, 2021Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, HEAVILY TORTUOUS, 90% STENOSED, DE NOVO LESION IN THE MID-LEFT CIRCUMFLEX (MLCX) ARTERY. AFTER PRE-DILATATION, THE 2.25X12MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION WITH RESISTANCE FROM THE ANATOMY. AS THE DES WAS BEING INFLATED, IT WAS NOTED THAT THE STENT HAD DISLODGED IN THE PROXIMAL LEFT CIRCUMFLEX. THE DES WAS UNABLE TO BE RETRIEVED SO IT WAS CRUSHED, WITH A NON-ABBOTT BALLOON, TO THE VESSEL WALL. A 3.5X15 XIENCE SKYPOINT DES WAS THEN DEPLOYED OVER THE CRUSHED STENT. KISSING BALLOON TECHNIQUE (KBT) WAS PERFORMED AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 11369508 ↗