XIENCE Skypoint™ 1804250-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08717648233081), received between Jul 7, 2021 and May 21, 2026 — classified as 9 injuries, 22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 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 (2.5 X 18, 2.75 X 23, 3.5 X 28 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 25243710 ↗
• MalfunctionNov 24, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  SUBSEQUENT TO THE INITIAL REPORT BEING FILED, IT WAS REPORTED THAT WHAT WAS REPORTED AS A RUPTURE WAS AN OUTER MEMBER (SHAFT) LEAK NOTED 5MM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH.NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632706 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL-MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.5X18MM XIENCE SKPOINT STENT WAS IMPLANTED, POST IMAGING WAS PERFORMED AND STENT WAS POST DILATATED WITH UNSPECIFIED NC TREK BALLOON. THE PATIENT BEGAN TO VOMIT AND ST ELEVATION WAS OBSERVED. UPON RE-IMAGING THE LAD WAS OBSERVED TO BE OCCLUDED DOWN FROM THE OSTIUM TO DISTAL BED. ANGIOPLASTY CONFIRM ACUTE THROMBOSIS AND A NON-ABBOTT STENT WAS PLACED PROXIMAL TO THE EXISTING STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 22925818 ↗
• MalfunctionAug 26, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY. THE 2.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED INTO THE DIAGNOSTIC CATHETER AND SIGNIFICANT RESISTANCE WAS NOTED. IT WAS DECIDED TO REMOVE THE SDS FROM THE CATHETER BUT THE STENT BECAME DISLODGED WHEN THE SDS WAS OUTSIDE THE ANATOMY. A DIFFERENT DEVICE WAS USED TO TREAT THE LESION SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898822 ↗
• InjuryJun 30, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; 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 LEFT MAIN CORONARY AND RAMUS ARTERY WITH MILD TO MODERATE CALCIFICATION. AN UNSPECIFIED STENT WAS IMPLANTED IN THE LEFT MAIN ARTERY. THEN, THE PHYSICIAN DIRECTED AN UNSPECIFIED GUIDE WIRE (GW) INTO THE RAMUS ARTERY AND THE LESION WAS BALLOONED SUCCESSFULLY. THE 2.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS THEN ATTEMPTED TO BE ADVANCED TO THE RAMUS ARTERY; HOWEVER, THE SDS MET RESISTANCE WHEN ADVANCING THROUGH THE FIRST IMPLANTED STENT AND THE SDS BECAME STUCK WITH THE IMPLANTED STENT. AN ATTEMPT WAS MADE TO REMOVE THE SDS, BUT THE STENT BECAME DISLODGED AND ONLY THE DELIVERY SYSTEM AND GW WERE ABLE TO BE REMOVED FROM THE PATIENT. THEREFORE, THE DISLODGED STENT WAS CRUSHED WITH A NC TREK BALLOON AGAINST THE INITIALLY IMPLANTED STENT, ENDING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22366684 ↗
• InjuryApr 25, 2025Difficult to Remove; Device Damaged by Another Device; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH CALCIFICATION. THE AREA INTENDED TO BE TREATED WAS AN UNSTENTED GAP BETWEEN TWO UNSPECIFIED PREVIOUSLY IMPLANTED STENTS. AN ACTIVATED CLOTTING TIME (ACT) TEST WAS PERFORMED AND THEN AN UNSPECIFIED 1.4 MM LASER WAS USED FOR IN STENT RESTENOSIS IN THE PROXIMAL STENT. THE 2.5X18 MM XIENCE SKYPOINT STENT WAS THEN IMPLANTED AT 9 ATMOSPHERES IN THE GAP AND OVERLAPPING AREAS WERE EXPANDED WITH THE STENT BALLOON. A NON-ABBOTT SCORING BALLOON WAS ADVANCED TO THE DISTAL STENT FOR ANGIOPLASTY. HOWEVER, UPON REMOVAL, THE BALLOON CAUGHT ON THE XIENCE SKYPOINT STENT AND THE STENT BECAME DEFORMED AND SHORTENED. THE PATIENT WAS SENT FOR OPEN HEART SURGERY TO REMOVE THE BALLOON AND THE DEFORMED STENT. THERE WERE NO ADVERSE PATIENT SEQUELA DURING THE PROCEDURE AND THE PATIENT IS STABLE FOLLOWING THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912860 ↗
• MalfunctionAug 21, 2024Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. ABLATIONS WERE PERFORMED A 2.25X18MM NON-ABBOTT BALLOON WAS USED TO PRE-DILATE THE LESION. THE 2.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, RESISTANCE WAS FELT ANATOMY. WHEN ATTEMPTING TO DEPLOY THE STENT THE BALLOON ON THE DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES. THE STENT WAS NOT DEPLOYED AND WAS REMOVED WITH THE DELIVERY SYSTEM. A NEW 2.25X10MM NON-ABBOTT BALLOON WAS USED TO INFLATE THE LESION A 2.25X18MM XIENCE SKYPOINT WAS IMPLANTED. A 2.5X10MM BALLOON WAS USED TO PERFORM POST-DILATATION SEVERAL TIMES. 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 20014713 ↗
• MalfunctionMar 15, 2024Difficult to Remove; Material Rupture; Difficult to Advance; Activation Failure; Difficult to Remove; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH HEAVY CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. A GUIDE WIRE WAS DELIVERED AND TWO NON-ABBOTT BALLOONS WERE USED FOR PRE-DILATATION. THEN, THE 2.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE LESION AND DEPLOYMENT WAS ATTEMPTED. THE DEVICE WAS INFLATED ONCE TO 2 ATMOSPHERES AND IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE SDS WAS ATTEMPTED TO BE REMOVED BUT THERE WAS RESISTANCE WITH THE ANATOMY. A PINHOLE RUPTURE WAS NOTED. A GUIDE CATHETER WHICH WAS ALREADY PRESENT INSIDE THE ANATOMY WAS ADVANCED TO MOUNT THE STENT AND THEN THE SDS WAS PULLED STRONGLY AND THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDING CATHETER. TWO NON-ABBOTT STENTS WERE DEPLOYED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. UPON REMOVAL FROM THE ANATOMY THE SDS WAS INSPECTED AND A PINHOLE RUPTURE WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18915415 ↗
• MalfunctionJan 8, 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, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 2.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS FELT WITH ANATOMY AND THE STENT'S STRUTS BECAME EXTENDED (STRETCHED). A NON-ABBOTT DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. 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 18466329 ↗
• MalfunctionDec 15, 2023Difficult 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 LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 99% STENOSED. THE XIENCE SKYPOINT SETENT DELIVERY SYSTEM FAILED TO CROSS AND THERE WAS DIFFICULTY DURING REMOVAL FROM THE ANATOMY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 18339896 ↗
• MalfunctionDec 4, 2023Material Rupture; Material Rupture

  RETURN DEVICE ANALYSIS NOTED THE HYPOTUBE WAS SEPARATED. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE SEPARATION WAS NOT NOTED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256800 ↗
• InjurySep 7, 2023Material Rupture; Difficult or Delayed Activation; Activation Failure; Material Rupture; Difficult or Delayed Activation; Activation Failure

  SUBSEQUENTLY, AFTER THE INITIAL WAS FILED IT WAS NOTED AFTER THE DELIVERY SYSTEM BALLOON RUPTURED THE STENT HAD PARTIALLY DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703514 ↗
• MalfunctionApr 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, WHEN THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PACKAGE, THE SHAFT WAS OBSERVED TO HAVE SEPARATED IN TWO PIECES. THERE WAS NO DAMAGE REPORTED TO THE DEVICE PACKAGING. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16840468 ↗
• MalfunctionFeb 27, 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 LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS NOTED DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16445853 ↗
• MalfunctionFeb 27, 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 LEFT CIRCUMFLEX ARTERY. THE 2.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS FELT DURING REMOVAL WITH ANATOMY. A NON-ABBOTT STENT 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 16445709 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A 2.50X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS IMPLANTED, WITHOUT ISSUE, IN A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE FIRST DIAGONAL ARTERY. ON (B)(6) 2022, THE PATIENT COMPLAINED OF CHEST PAIN. ON (B)(6) 2022, CORONARY ANGIOGRAPHY CONFIRMED 99% FOCAL LESION IN THE FIRST DIAGONAL ARTERY, WHICH WAS TREATED WITH A DRUG COATED BALLOON (DCB), WITHOUT ANY ISSUES. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 16383106 ↗
• MalfunctionJan 6, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 2.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO ADVANCE DUE TO IT BEING STUCK WITH AN UNSPECIFIED GUIDE WIRE. A 2.5X23 MM XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 16117526 ↗
• MalfunctionJan 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND THE PROCEDURE WAS PERFORMED EMERGENTLY TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) ARTERY. A 2.5X18MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE TARGET LESION AND IMPLANTED AT 12 ATMOSPHERES (ATM) WITHOUT ISSUE; HOWEVER, DURING POST-DILATATION OF THE STENT WITH THE STENT DELIVERY SYSTEM BALLOON, THE BALLOON RUPTURED AT 14 ATM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. 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 16098603 ↗
• MalfunctionDec 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 2.5X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND DURING REMOVAL THERE WAS RESISTANCE WITH THE ANATOMY. A NON-ABBOTT SDS 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 16024994 ↗
• InjurySep 28, 2022Material Rupture; Difficult or Delayed Activation; Patient-Device Incompatibility; Material Rupture; Difficult or Delayed Activation; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID CIRCUMFLEX ARTERY THAT WAS 90% STENOSED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM NC TREK AT 2 INFLATIONS WITHOUT ISSUE. THEN A 2.5X18MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE LESION WITHOUT ISSUE. DEPLOYMENT WAS INITIATED AND THE STENT PARTIALLY DEPLOYED, WHEN IT WAS NOTED THAT THE STENT-BALLOON COULD NOT BE PRESSURIZED PAST 2 ATMOSPHERES AND LEAKAGE WAS NOTED COMING FROM A PINHOLE ON THE BALLOON. THE STENT IMPLANT HAD PARTIALLY DEPLOYED AT THE LESION (NOT WELL APPOSED TO THE VESSEL WALL), SO IT WAS DECIDED TO REMOVE THE DELIVERY SYSTEM. THE PATIENTS PRESSURE IMMEDIATELY DROPPED AND EKG CHANGES WERE NOTED. THE PATIENT BECAME UNRESPONSIVE FOR 30 SECONDS. MEDICATION WAS ADMINISTERED AND THE PATIENTS VITALS STABILIZED AND RETURNED TO NORMAL. THEN A 1.5X8MM AND A 2.5MM BALLOONS WERE USED TO FULLY IMPLANT THE XIENCE IMPLANT SUCCESSFULLY. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes

  MAUDE report 15499328 ↗
• MalfunctionJul 19, 2022Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. A BMW GUIDEWIRE (GW) WAS POSITIONED AND A TREK BALLOON WAS USED FOR LESION PRE-DILATATION. THEN, THE 014 WHISPER GW WAS POSITIONED. THE 2.50X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT FAILED TO REACH THE LESION AS IT BECAME STUCK AND CAUGHT WITH THE WHISPER GW. THE GW AND SDS WERE REMOVED TOGETHER FROM THE ANATOMY. A KINK ON THE MONORAIL LUMEN OF THE SDS WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. A 2.25MM XIENCE SKYPOINT STENT AND A NON-ABBOTT GW WERE USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059978 ↗
• InjuryJul 1, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CARDIAC ARREST, BEING RESUSCITATED DUE TO AN ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) IN THE LEFT MAIN. IT WAS NOTED THAT THE LESION IN THE LEFT MAIN ARTERY WAS HEAVILY CALCIFIED AND MODERATELY TORTUOUS. TWO GUIDE WIRES WERE ADVANCED THROUGH THE LEFT MAIN, ONE DOWN THE LEFT ANTERIOR DESCENDING(LAD) ARTERY AND ONE DOWN THE RAMUS INTERMEDIUS (RI) ARTERY. FOUR XIENCE SKYPOINT STENTS (2-2.5X18, 2-3.0X18) WERE ATTEMPTED, BUT FAILED TO REACH THE LESION AT SOME POINT DURING THE PROCEDURE, A DISSECTION WAS NOTED; HOWEVER, IT WAS UNKNOWN WHAT CAUSED IT. THE DISSECTION WAS TREATED WITH A NON-ABBOTT STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND POST PROCEDURE THE PATIENT STATUS WAS GOOD AND THE PATIENT WAS STABLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14888318 ↗
• MalfunctionJun 28, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. AFTER THE LESION WAS PREDILATED, THE 2.5X18MM XIENCE SKYPOINT STENT SYSTEM WAS ADVANCED TO THE LESION AND DURING STENT DEPLOYMENT, A LEAK WAS NOTED, SO HIGH-SPEED INFLATION WAS PERFORMED, SUCCESSFULLY IMPLANTING THE STENT. AFTER REMOVAL OF THE STENT DELIVERY SYSTEM, A PINHOLE RUPTURE WAS NOTED ON THE TIP OF THE DEVICE. POST-DILATATION WAS PERFORMED WITH AN NC BALLOON AND INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THE STENT WAS WELL APPOSED TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848821 ↗
• MalfunctionJun 23, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 90% ECCENTRICALLY STENOSED, HEAVILY CALCIFIED AND HEAVILY TORTUOUS VESSEL IN THE FIRST OBTUSE MARGINAL (1ST OM) ARTERY. THE 2.5X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) MET RESISTANCE DUE TO THE ANATOMY AND FAILED TO CROSS THE LESION. THERE WAS NO DEVICE INTERACTION. THE SDS WAS REMOVED INDEPENDENTLY. THERE WAS RESISTANCE 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 14793741 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT WAS ADMITTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI). THREE XIENCE SKYPOINT STENTS (2.25X23MM, 2.5X18MM, 2.75X23MM) WERE IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS RE-HOSPITALIZED WITH CHEST PAIN AND STEMI. PERCUTANEOUS CORONARY ANGIOPLASTY WAS PERFORMED IN TWO PLACES, RESOLVING THE EVENT AND THE PATIENT WAS DISCHARGED HOME WITH NO ADVERSE SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Myocardial Infarction

  MAUDE report 14190850 ↗