XIENCE Skypoint™ 1804400-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08717648233517), received between Aug 26, 2021 and Sep 23, 2024 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Leak/Splash; Loose or Intermittent Connection; Product Quality Problem; Leak/Splash; Loose or Intermittent Connection; Product Quality Problem

  IT WAS REPORTED THAT A 4.0X33MM RX XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DES) WAS ADVANCED TO THE TARGET LESION HOWEVER WHEN ATTEMPTING TO INFLATE THE DEVICE CONTRAST WAS NOTED TO BE EXITING FROM THE LUER LOCK. IT APPEARED THE LUER THREADS WERE DEFORMED AND COULD NOT CONNECT CORRECTLY TO THE INDEFLATOR. THE SKYPOINT WAS REPLACED WITH ANOTHER XIENCE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281206 ↗
• MalfunctionJun 17, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT POPLITEAL ARTERY WITH MODERATE CALCIFICATION. THE 4.0X33 MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUE. AFTER DEPLOYMENT, THE DELIVERY SYSTEM AND GUIDE WIRE WERE REMOVED TOGETHER AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. OUTSIDE THE ANATOMY, THE DELIVERY SYSTEM HAD TO BE CUT IN ORDER TO REMOVE THE DEVICES FROM ONE ANOTHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548266 ↗
• DeathDec 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION AND THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE TO SEVERE CALCIFICATION. AN INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED FOR CALCIUM MODIFICATION, HOWEVER, A DISSECTION OCCURRED IN THE MID RCA. THE 4.5X15MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS USED WITHOUT ISSUES AND THEN A 4.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS USED TO TREAT THE DISSECTION. ANOTHER 2 NC TREK NEO BALLOONS, 4.5X12MM AND 4.5X15MM, WERE USED WITHOUT ISSUES AND A 4.5X15MM XIENCE SKYPOINT STENT WAS IMPLANTED SUCCESSFULLY IN THE PROXIMAL RCA. ANOTHER 4.5X12MM NC TREK NEO BALLOON WAS USED FOR POST DILATATION AND INFLATED TO 30 ATMOSPHERES (ATMS) WHEN A PERFORATION OCCURRED IN THE MID RCA. THE PHYSICIAN THEN USED A 4.0X20MM TREK BALLOON AS A TAMPONADE THEN PLACED A NON-ABBOTT COVERED STENT TO TREAT THE PERFORATION, HOWEVER, AT THAT POINT THE PATIENT ALREADY EXPIRED. REPORTEDLY, THE CAUSE OF DEATH WAS THE PERFORATION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 18253527 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 4.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED ON (B)(6) 2022 TO TREAT THE RIGHT CORONARY ARTERY (RCA). SINCE THE STENT WAS IMPLANTED THE PATIENT DEVELOPED A RASH FROM HER NECK TO THE LOWER EXTREMITIES INCLUDING THE CHEST, ARMS, BACK, AND THIGHS. THE RASH IS UNCOMFORTABLE WITH UNBEARABLE ITCHING AND DUE TO THE RASH, SHOWERS ARE PAINFUL TOO; THEREFORE, MEDICATION WAS PROVIDED BUT WERE REMOVED ONE AT A TIME SINCE TO TRY AND DETERMINE IF THE MEDICATION CAUSED THE ISSUE. ALL MEDICATIONS HAVE STOPPED AT THIS POINT; THEREFORE, THE PATIENT BELIEVES THERE IS A HYPERSENSITIVITY/ALLERGY TO THE STENT. THIS IS DUE TO THE PREVIOUS SENSITIVITY TO METAL IMPLANTS FROM A PREVIOUS BACK PROCEDURE. THE PATIENT HAS SEEN AN ALLERGIST AND A DERMATOLOGIST AND AT THE DERMATOLOGIST A BIOPSY WAS PERFORMED WHICH CONCLUDED THERE WAS DERMATITIS. THE PATIENT HAS RECEIVED 3 MONTHS OF CARDIAC REHABILITATION. THE PATIENT HAS SEEN MANY DOCTORS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 17079170 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED SOME OF THE IMAGES WITH THE DRAGONFLY OPTIS IMAGING CATHETER HAD POOR IMAGE DURING PRE-STENTING. WHEN REMOVING THE DRAGONFLY, THE CATHETER CAME OUT OF THE GUIDE CATHETER WITHOUT THE GUIDEWIRE, IT NORMALLY COMES OUT WITH THE GUIDE WIRE; IT HAD BEEN ADVANCED ON THE GUIDE WIRE. THERE WAS NO ISSUE DISCONNECTING THE DEVICE FROM THE DOC. AFTER IMAGING, A 4.0X33MM SKYPOINT STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH MILD CALCIFICATION AND A DISTAL DISSECTION WAS OBSERVED. A 3.0X15MM SKYPOINT STENT WAS IMPLANTED FOR TREATMENT. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 16461166 ↗
• MalfunctionOct 18, 2022Difficult 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 4.00X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER FAILED TO CROSS DUE TO THE ANATOMY. THE SDS WAS REMOVED WITH RESISTANCE DUE TO THE ANATOMY. 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 15629508 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN A MEETING ABSTRACT THAT THE PATIENT DEVELOPED ACUTE HEART FAILURE AND WAS DIAGNOSED WITH VERY SEVERE AORTIC STENOSIS. AFTER MULTIPLE PROCEDURES WERE PERFORMED, A 4.0X33 MM XIENCE SKYPOINT STENT WAS ADVANCED FROM INSIDE A NEWLY IMPLANTED TRANSCATHETER AORTIC VALVE. PERICARDIAL FLUID WAS NOTED AS INCREASING GRADUALLY DURING THE INTERVENTION AND THE BLOOD PRESSURE DECREASED. MOREOVER, AN ASCENDING AORTIC DISSECTION WAS NOTED BY POST-PERCUTANEOUS CORONARY INTERVENTION (PCI) AORTOGRAM. AN EMERGENCY THORACOTOMY WAS PERFORMED. AFTER REMOVAL OF THE STENT DELIVERY SYSTEM, A PROCEDURE WAS PERFORMED TO REPLACE PART OF THE AORTA AND THE AORTIC VALVE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY UNTIL DISCHARGE HOME. THE XIENCE SKYPOINT SDS FUNCTIONED AS INTENDED; HOWEVER IT IS UNKNOWN IF THE STENT CAUSED OR CONTRIBUTED TO THE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion

  MAUDE report 15569950 ↗
• InjurySep 7, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO, 100% STENOSED, MODERATELY CALCIFIED, MILDLY TORTUOUS VESSEL IN THE RIGHT CORONARY ARTERY (RCA). IT WAS AN ACUTE CORONARY SYNDROME (ACS) NO FLOW CASE AND AFTER A NON-ABBOTT GUIDE WIRE CROSSED, THERE WAS FLOW; HOWEVER, NUMEROUS THROMBUS WERE FOUND SO A NON-ABBOTT THROMBECTOMY DEVICE WAS USED. A 2.5X10 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS USED FOR DILATATION. THROMBUS WAS AGAIN ABSORBED WITH THE NON-ABBOTT THROMBECTOMY DEVICE AND FURTHER DILATION WAS PERFORMED. THE 4.0X33MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND REACHED THE LESION WITH RESISTANCE FROM THE ANATOMY. DURING POSITIONING THE SDS GOT STUCK AND WOULD NOT MOVE WHEN BEING PUSHED OR PULLED. THE XIENCE SKYPOINT SDS WAS ATTEMPTED TO BE PULLED WITH FORCE; HOWEVER, THE STENT DISLODGED IN THE RCA. THE STENT WAS ATTEMPTED TO BE RETRIEVED BY THREE GUIDE WIRES BUT THIS WAS UNSUCCESSFUL. IT WAS NOTED THAT THE PROXIMAL PART OF THE STENT BECAME FLARED AND COULD NOT BE PULLED THROUGH THE GUIDING CATHETER. THE DISLODGED, FLARED STENT WAS ULTIMATELY RETRIEVED FROM THE FEMORAL ACCESS FORCEFULLY WITH A SNARE DEVICE. THERE WAS NO EVIDENCE OF A STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435646 ↗
• InjuryAug 26, 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 DE NOVO LESION IN THE 100% STENOSED, MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PATIENT PRESENTED WITH ACUTE MYOCARDIAL INFARCTION (AMI). THE 4.0X33 MM XIENCE SKYPOINT STENT WAS IMPLANTED AT 16 ATMOSPHERES (ATM). THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU) BUT AFTER FIVE MINUTES, THE PATIENT HAD A FURTHER AMI AND A THROMBUS WAS CONFIRMED VIA ANGIOGRAPHY IN THE DISTAL PART OF THE STENT. THROMBUS ASPIRATION AND BALLOON DILATATION WAS PERFORMED. A DELAY IN THE PROCEDURE WAS REPORTED. THE PATIENT IS REPORTEDLY RECOVERING AND RECEIVED DUAL ANTIPLATELET THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 12374116 ↗