XIENCE Skypoint™ 1804400-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08717648233500), received between Aug 3, 2021 and Dec 22, 2025 — classified as 1 death, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A FIRST OBTUSE MARGINAL CORONARY ARTERY. A 4.00X28MM XIENCE SKYPOINT DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, A DISSECTION OCCURRED AND THE SDS WAS UNABLE TO CROSS TO THE LESION. A 4.0X28MM NON-ABBOTT DES WAS USED TO COVER THE DISSECTION. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 23872993 ↗
• MalfunctionOct 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE 4.0X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS PREPPED AND UPON ATTEMPTED REMOVAL OF THE PROTECTIVE SHEATH, THE SHEATH COULD NOT BE REMOVED. THEREFORE, THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383827 ↗
• MalfunctionMay 20, 2025Material Rupture; Difficult to Advance; Activation Failure; Material Rupture; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY THAT IS 90% STENOSED. PRE-DILATION WAS PERFORMED USING A 3.5X15MM NON-ABBOTT CORONARY CUTTING BALLOON. DURING ADVANCEMENT OF THE 4.0X28MM XIENCE SKYPOINT DRUG-ELUTING STENT (DES), RESISTANCE WAS NOTED DUE TO ANATOMY BUT ULTIMATELY CROSSED THE LESION. THE XIENCE SKYPOINT DES RUPTURED AT 6 ATMOSPHERES DURING THE FIRST INFLATION AND FAILED TO DEPLOY. THE XIENCE SKYPOINT WAS REMOVED ALONG WITH THE BALLOON. ADDITIONAL DILATION WAS PERFORMED USING A 4.0X10MM NON-ABBOTT BALLOON. A 4.0X15MM XIENCE SKYPOINT DES AND 4.0X18MM XIENCE SKYPOINT DES WERE SUCCESSFULLY DEPLOYED. POST-DILATION WITH A 4.0X10MM NON-ABBOTT BALLOON WAS USED CONCLUDING 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 22055072 ↗
• MalfunctionMay 22, 2024Deflation Problem; Improper or Incorrect Procedure or Method; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. THE 4.0X28MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS NOT PREPARED FOR USE OUTSIDE THE PATIENT ANATOMY. THE SDS WAS ADVANCED TO THE TARGET LESION AND THE STENT DEPLOYED; HOWEVER POST DEPLOYMENT NEGATIVE WAS APPLIED FOR 5 SECONDS AND THE BALLOON WOULD NOT DEFLATE. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON; THE PATIENT EXPERIENCED CHEST PAIN DUE TO THE INFLATED BALLOON. FINALLY ON THE THIRD ATTEMPT THE BALLOON PARTIALLY DEFLATED AND THE SDS WAS ABLE TO BE REMOVED AND THE CHEST PAIN RESOLVED. THERE WAS NO DAMAGE NOTED TO THE IMPLANTED STENT AND THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 19376981 ↗
• MalfunctionJan 3, 2024Inflation Problem; Deformation Due to Compressive Stress; Difficult to Advance; Inflation Problem; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING CORONARY THAT WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THE XIENCE SKYPOINT DES 4.00 X 28 RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND RESISTANCE WAS NOTED DURING ADVANCEMENT TO THE LESION. THE SDS BALLOON WAS INFLATED BUT THE STENT COULD NOT COMPLETELY BE IMPLANTED AS THE STENT SHAFT WAS BENT. A NEW STENT WAS USED AND IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439778 ↗
• MalfunctionDec 4, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED, HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL LEFT CIRCUMFLEX (PLCX) ARTERY. A 4.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO ANATOMY. THERE WAS ALSO RESISTANCE FELT WITH THE ANATOMY DURING REMOVAL OF THE SDS. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256659 ↗
• MalfunctionOct 23, 2023Difficult 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 DISTAL RIGHT CORONARY ARTERY THAT WAS MILDLY TORTUOUS AND 90% STENOSED. AFTER PRE-DILATATION, THE 4.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT FAILED TO CROSS DUE TO RESISTANCE WITH THE LESION. THERE WAS ALSO RESISTANCE WITH THE LESION DURING REMOVAL OF THE SDS. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986304 ↗
• InjuryJun 14, 2023Difficult or Delayed Positioning; Off-Label Use; Migration; Difficult or Delayed Positioning; Off-Label Use; Migration

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MILDLY CALCIFIED TIBIAL /POPLITEAL TRUNK. THE 4.0X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND DEPLOYED; HOWEVER, IT WAS BELIEVED THE STENT DID NOT DEPLOY AS IT WAS NOT VISIBLE ON THE XRAY. THE SDS WAS REMOVED AND THE STAFF BEGAN TO LOOK FOR THE STENT OUTSIDE THE PATIENT, BUT COULD NOT FIND THE STENT. THEREFORE, A CT SCAN WAS PERFORMED AND NOTED THE STENT HAD MIGRATE DOWN BELOW THE KNEE. NO INTERVENTION WAS MADE TO REMOVE THE STENT AND REMAINS FREE FLOATING. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES". DESCRIBE THE EVENT OR PROBLEM: SURGEON DEPLOYED A CORONARY STENT TO THE LOWER LEG (XIENCE SKYPOINT 4.0 MMX 28 MM). UPON REVIEW, THEY NOTICED THAT IT IS NOT VISIBLE ON X-RAY WITH C-ARM. CHARGE NURSE WAS MADE AWARE, INSPECTED THE CATHETER AND PACKAGING, AS WELL AS SEARCHED THE ROOM. MANAGER WAS MADE AWARE, AND SURGEON ORDERED FOR PATIENT TO GO TO CT FOR A FULL BODY CT SCAN AFTER PACU (POST ANESTHESIA CARE UNIT). PACKAGE WAS SAVED FOR INSPECTION. WHAT WAS THE ORIGINAL INTENDED

  Patient problems: Foreign Body In Patient

  MAUDE report 17129797 ↗
• MalfunctionMar 8, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS AGO A 4.0X28MM XIENCE SKYPOINT STENT WAS SUCCESSFULLY IMPLANTED IN THE VERTEBRAL ARTERY. ON (B)(6) 2023, THE PATIENT UNDERWENT A ROUTINE FOLLOW UP, AND IT WAS DISCOVERED THROUGH IMAGING THAT THE STENT HAD A COMPRESSED/SHORTENED AREA. THERE WAS NO HARM TO THE PATIENT. THE STENT IS PATENT AND THE PATIENT HAS NO SYMPTOMS WITH NO TREATMENT BEING ADMINISTERED AT THIS TIME. THE PATIENT WAS SENT HOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505479 ↗
• DeathDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT WITH A HISTORY OF NON-ST ELEVATION MYOCARDIAL INFARCTION HAD ONE 4.0X28MM XIENCE SKYPOINT STENT IMPLANTED. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED WITH SEPSIS AND CHRONIC ISCHEMIC HEART DISEASE. NO TREATMENT WAS PROVIDED. THE PATIENT EXPIRED ON (B)(6) 2022 AND THE CAUSE OF DEATH WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 16025137 ↗
• InjurySep 16, 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 THE MID RIGHT CORONARY ARTERY (RCA) AND THE DISTAL RCA. THE PATIENT HAD TWO UNSPECIFIED XIENCE SKYPOINT STENTS IMPLANTED IN (B)(6) OF 2022. A 2.5X15MM TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO PRE-DILATE BETWEEN THE TWO STENTS. SLOW DEFLATION OF THE BDC WAS NOTED, BUT HAD NO FURTHER ISSUES AND WAS REMOVED SUCCESSFULLY. OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THERE WAS A GAP BETWEEN THE TWO PREVIOUSLY IMPLANTED STENTS AND A 4.0X12MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY WITH SLOW DEFLATION OF THE DEVICE NOTED; HOWEVER, THE STENT DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY. A 4.0X38MM XIENCE SKYPOINT STENT WAS ATTEMPTED TO BE IMPLANTED PROXIMALLY FROM THE PREVIOUSLY IMPLANTED XIENCE SKYPOINT IN JANUARY; HOWEVER, FAILED TO BE IMPLANTED AS INTERACTION WITH THE PREVIOUSLY IMPLANTED STENT WAS FELT. THE 3.5X20MM TREK BALLOON DILATATION CATHETER WAS ADVANCED, THEN INFLATED TWICE TO 12 AND 10 ATMOSPHERES. THE PHYSICIAN ATTEMPTED THREE TIMES TO PULL NEGATIVE, BUT THE BDC WOULD NOT DEFLATE. IT WAS DECIDED TO REMOVE THE BDC WITH THE ENTIRE SYSTEM AS ONE UNIT. DURING REMOVAL THE SHAFT SEPARATED AND BECAME LODGED IN THE ELBOW A

  Patient problems: Angina; Dyspnea; Fatigue; Thrombosis/Thrombus

  MAUDE report 15442239 ↗
• MalfunctionApr 28, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THERE WAS DIFFICULTY IN REMOVING THE STYLET FROM THE 4.00 X 28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM; THEREFORE, THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE DEVICE WAS REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246558 ↗
• MalfunctionSep 24, 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, 99% STENOSED, DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 4X28MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT CROSS THE ANATOMY TO REACH THE TARGET LESION. UPON REMOVAL, THE DES MET RESISTANCE WITH THE ANATOMY BUT WAS ABLE TO BE REMOVED. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETED 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 12530590 ↗
• InjuryAug 3, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. ATHERECTOMY WAS PERFORMED AS WELL AS PRE-DILATATION WITH A NON-COMPLIANT BALLOON. A 4X28MM XIENCE SKYPOINT STENT WAS ADVANCED TO THE LESION AND RIGHT BEFORE DEPLOYMENT WAS INITIATED, A DISSECTION WAS NOTED AT THE PROXIMAL EDGE OF WHERE THE STENT WAS TO BE IMPLANTED. IT WAS DECIDED TO REMOVE THE NON-DEPLOYED XIENCE SKYPOINT AND PERFORM ADDITIONAL BALLOON TAMPONADE WITH A SEMI-COMPLIANT BALLOON. THE XIENCE SKYPOINT STENT WAS RE-INSERTED AND PLACED AT THE TARGET LESION AND TREATED THE DISSECTION. STANDARD POST DILATATION WAS PERFORMED. PER THE PHYSICIAN, IT IS UNKNOWN IF THE NON-COMPLIANT BALLOON OR XIENCE SKYPOINT CAUSED THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 12269208 ↗