XIENCE Skypoint™ 1804275-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08717648233173), received between May 19, 2021 and May 21, 2026 — classified as 7 injuries, 15 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND CORONARY ARTERY STENOSIS, HAD THREE XIENCE SKYPOINT (2.5X18, 2.75X23, 3.5X28 MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2026 WITH CHRONIC ISCHEMIC HEART DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED WITH STENT PLACEMENT ON (B)(6) 2026. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT WAS RE-ADMITTED WITH DYSPNEA. NO TREATMENT WAS REPORTED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 25243703 ↗
• MalfunctionMar 31, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE DELIVERY SYSTEM BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THE SDS WITH THE STENT WERE ABLE TO BE REMOVED WITHOUT ISSUE. ADDITIONAL DILATATION WAS PERFORMED, FOLLOWED BY IMPLANTATION OF A 2.5X23MM XIENCE SKYPOINT STENT. 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 24743180 ↗
• MalfunctionJan 2, 2026Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY. RESISTANCE WAS MET WHEN ADVANCING THE 2.75X23MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES) THROUGH A 5.5 FRENCH NON-ABBOTT GUIDELINER. THE DES WAS PULLED BACK; HOWEVER, RESISTANCE WAS ALSO MET WITH THE GUIDELINER. THE DES AND GUIDELINER WERE REMOVED AS ONE UNIT AND THE STENT TIP OF THE XIENCE SKYPOINT APPEARED TO BE MANGLED. A NEW XIENCE DES WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23949677 ↗
• MalfunctionOct 28, 2025Leak/Splash; Improper or Incorrect Procedure or Method; Difficult to Advance; Leak/Splash; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT CIRCUMFLEX (LCX) WITH MILD CALCIFICATION AND MILD TORTUOSITY. AFTER PRE-DILATION, THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY (SDS) WAS ADVANCED AND NEGATIVE PRESSURE WAS APPLIED TO THE DELIVERY SYSTEM, WHEN BLOOD WAS NOTED TO HAVE ASPIRATED [LEAK] IN THE SYRINGE. THE SDS WAS REMOVED FROM THE PATIENT. A NON-ABBOT DRUG ELUTING STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408348 ↗
• MalfunctionAug 5, 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 PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.75 X 23MM RX XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS PREPPED PRIOR TO REMOVING THE PROTECTIVE SHEATH. THE SDS WAS ADVANCED TO THE LESION FOR DEPLOYMENT; HOWEVER, THE STENT WAS NOTED TO BE DISLODGED AND LOCATED AT THE RADIAL ACCESS SITE OF THE COPILOT. THE DES WITH THE DISLODGED STENT WAS SIMPLY REMOVED AND REPLACED WITH ANOTHER XIENCE DES AND THE PROCEDURE WAS COMPLETED. 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 19906376 ↗
• MalfunctionJun 13, 2024Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE XIENCE SKYPOINT DELIVERY SYSTEM WAS ADVANCED YET FAILED TO CROSS THE LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY DUE TO HEAVY CALCIFICATION. UPON WITHDRAWAL WITH NO RESISTANCE, THE SHAFT WAS NOTED TO BE BENT AND SEPARATED INTO TWO PIECES OUTSIDE THE ANATOMY. A NON-ABBOTT STENT 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 19529216 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A XIENCE SKYPOINT STENT WAS IMPLANTED AND SOME TIME LATER THE PATIENT EXPERIENCED A POTENTIAL ALLERGIC REACTION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA. SUBSEQUENT TO THE INITIALLY FILED REPORT, 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 HAVE BEEN PROVIDED AND THE REACTION IS STILL PRESENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 18842434 ↗
• InjuryJan 11, 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 STENTS IS 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 EVEROLIMUS ELUTING CORONARY, MANUFACTURER ABBOTT LABORATORIES. MODEL NUMBER 1804225-12; LOT NUMBER 3011941; DESCRIPTION LAD (LEFT ANTERIOR DESCENDING). A FEW DAYS AFTER THE PROCEDURE, I STARTED GETTING SWELLING ON MY SCALP. THE SWELLING THEN PROGRESSIVELY EXTENDED TO EYES, FACE, EARS, NECK, CHEST, AND HAND, AND TO LESS EXTENT ON OTHER PARTS OF THE BODY. I ALSO FEEL SWELLING IN INTERNAL ORGANS LIKE HEART AND 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. I WAS PRESCRIBED PREDNISONE, DIPHENHYDRAMINE AND AMOXICILLIN-CLAVULANATE. I WAS ADVISED TO MEET WITH MY CARDIOLOGIST AND ALLERGY SPECIALIST WHICH I DID. AFTER COMPLET

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

  MAUDE report 18495559 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS A REPORTED THAT THE 2.75X23MM XIENCE SKYPOINT STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY APPROXIMATELY 1 YEAR AGO. ON (B)(6) 2023 THE PATIENT DID NOT RECEIVE DUAL ANTIPLATELET THERAPY (DAPT) MEDICATION AND WAS RE-HOSPITALIZED ON (B)(6) 2023 WITH CHEST PAIN, THROMBUS AND A MYOCARDIAL INFARCTION. THE LAD WAS NOTED TO HAVE RE-STENOSED. A NON-ABBOTT DEVICE WAS USED TO DE-CLOT THE LESION FOLLOWED BY IMPLANTATION OF A 3.25X15MM XIENCE SKYPOINT STENT TO TREAT THE RESTENOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 17545985 ↗
• MalfunctionMay 2, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD) WITH HEAVY CALCIFICATION NOTED DURING THE OPTICAL COHERENCE TOMOGRAPHY (OCT). PRE DILATATION WAS PERFORMED AND THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. ADDITIONAL DILATATION WAS PERFORMED, BUT THE STENT FAILED TO CROSS THE LESION AGAIN. THE SDS WAS REMOVED WITH RESISTANCE NOTED AND ANOTHER 2.75X18MM XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS 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 16854847 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Unspecified Infection

  MAUDE report 16658862 ↗
• MalfunctionDec 21, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION OF THE XIENCE SKYPOINT, AS THE STYLET WAS GETTING PULLED OUT IT BECAME STUCK. IT WAS PULLED HARDER AND WAS ABLE TO COME OUT, HOWEVER, IT WAS DECIDED TO USE ANOTHER NEW SAME SIZE DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE INCIDENT OCCURRED BEFORE PREPPING THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND THE DEVICE WAS NOT USED. 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 16026710 ↗
• MalfunctionDec 6, 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 99% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER FAILED TO ADVANCE DUE TO THE ANATOMY AND THE EDGE OF THE STENT STRUT WAS NOTED TO BE FLARED. THEREFORE, THE SDS WAS REMOVED WITH DIFFICULTY DUE TO THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 3.00X23 MM XIENCE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926983 ↗
• MalfunctionOct 1, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.75X23 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. AN UNSPECIFIED 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 15522549 ↗
• MalfunctionSep 7, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED AND TORTUOUS MID-DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. A 2.75X23MM XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WITH ANATOMY WAS ALSO MET. A DRUG COATED 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 15372359 ↗
• MalfunctionAug 3, 2022Product Quality Problem; Device Dislodged or Dislocated; Material Deformation; Product Quality Problem; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING UNPACKING OF A 2.75X33MM XIENCE SKYPOINT, IT WAS NOTED THAT THE STENT WAS COMPLETELY DISLODGED OFF THE DELIVERY SYSTEM AND THE BALLOON WAS ALREADY PARTIALLY INFLATED. THERE WAS NO RESISTANCE NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE DISPENSER HOOP COIL. THE DEVICE WAS CONFIRMED TO BE UNOPENED BEFORE OPENING FOR USE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER 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 15158906 ↗
• MalfunctionJun 16, 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 MID RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED AND HEAVILY TORTUOUS AND 90% STENOSED. THE 2.75X23MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED, BUT RESISTANCE WAS MET AND THE DEVICE FAILED TO CROSS THE LESION. RESISTANCE WAS NOTED DURING DEVICE REMOVAL. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY 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 14721300 ↗
• MalfunctionMay 9, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.75X23 MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE TARGET LESION; HOWEVER THE PHYSICIAN FELT AS THOUGH THERE WAS MORE BALLOON PROXIMAL TO THE MARKER ON THE STENT AND THAT THE BALLOON WENT MORE PROXIMAL IN THE VESSEL THAN IT SHOULD. THE STENT WAS IMPLANTED. 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 14337708 ↗
• MalfunctionApr 6, 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 DISTAL RIGHT CORONARY ARTERY (DRCA) WITH MODERATE CALCIFICATION AND HEAVY TORTUOSITY. A 2.75 X 23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, THE STENT COULD NOT CROSS THE LESION DUE TO ANATOMICAL CHALLENGES. THE SDS WAS REMOVED FROM THE PATIENT AND RESISTANCE WAS ALSO MET WITH THE LESION DURING REMOVAL. DESPITE THE USE OF AN EXTENSION CATHETER, ANOTHER UNSPECIFIED BALLOON COULD NOT CROSS THE TARGET LESION. THEREFORE, A NON-ABBOTT DRUG-COATED BALLOON WAS USED TO 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 14032154 ↗
• InjurySep 24, 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 A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 95% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. TWO-HOURS POST DEPLOYMENT OF A 2.75X23MM XIENCE SKYPOINT DRUG ELUTING STENT (DES), THE PATIENT WAS ON THE RECOVERY FLOOR WHEN HE EXPERIENCED CHEST PAIN. THE PATIENT WAS TAKEN TO THE CATH LAB AND IMAGING WAS PERFORMED SHOWING A TOTAL OCCLUSION OF THE IMPLANTED STENT. THE PATIENT WAS TREATED WITH MEDICATIONS AND AN UNSPECIFIED BALLOON WAS THEN ADVANCED AND POST-DILATATION TREATED THE OCCLUSION SUCCESSFULLY. SUBSEQUENTLY, THE PATIENT WAS FINE AND MOVED BACK TO THE RECOVERY FLOOR WITH NO FURTHER INTERVENTION REQUIRED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Obstruction/Occlusion

  MAUDE report 12530126 ↗
• InjurySep 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A 100% STENOSED AND MILDLY TORTUOUS DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.75X23 XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS INSERTED ADVANCED TO THE TARGET LESION. HOWEVER, DURING INFLATION, A CONTRAST LEAK OCCURRED DUE TO A PINHOLE RUPTURE. IT WAS THEN OBSERVED THAT A DISSECTION OF THE ARTERY SPREAD TO THE LEFT MAIN ARTERY. THE SDS WAS ABLE TO BE PRESSURIZED UP TO 16 ATMOSPHERES AND THE STENT WAS SUCCESSFULLY DEPLOYED. TO TREAT THE DISSECTION, AN ADDITIONAL XIENCE STENT WAS IMPLANTED. IT WAS NOTED THE VESSEL POST PROCEDURE STENOSIS WAS 20%. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 12492547 ↗
• MalfunctionMay 19, 2021Difficult 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 HEAVILY TORTUOUS, MODERATELY CALCIFIED DISTAL CIRCUMFLEX. THE 2.75X23MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, FAILED TO CROSS DUE TO ANATOMY. THE SDS WAS TAKEN OUT AND RE-INSERTED WITH AN EXTENSION CATHETER, BUT THE SDS STILL FAILED TO CROSS. DURING REMOVAL OF THE SDS RESISTANCE WAS MET WITH ANATOMY. AN UNSPECIFIED DILATATION CATHETER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849654 ↗