XIENCE Skypoint™ 1804250-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08717648233128), received between Jan 4, 2021 and Feb 16, 2026 — classified as 8 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Break

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 2.50 X 38MM XIENCE SKYPOINT DRUG-ELUTING STENT WAS IMPLANTED. POST DILATION WITH A NON-COMPLIANT BALLOON WAS PERFORMED WHEN A STENT FRACTURE WAS OBSERVED. A NEW XIENCE DES WAS IMPLANTED TO COVER THE STENT FRACTURE. 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 24349352 ↗
• MalfunctionMay 5, 2025Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS NOTED TO HAVE A HOLE IN THE BALLOON AND COULD NOT BE INFLATED TO DELIVER THE STENT. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT 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 21961852 ↗
• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERCUTANEOUS INTERVENTION (PCI) WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY ON (B)(6) 2024, WITH IMPLANT OF A 2.5X38MM XIENCE SKYPOINT STENT. THE PATIENT LEFT THE HOSPITAL THE SAME DAY AGAINST MEDICAL ADVICE (AMA), WITH NO DISCHARGE PAPERWORK. THE PATIENT WAS PRESCRIBED MEDICATIONS AND REPORTED COMPLIANCE. ON (B)(6) 2024, A MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE SPINE WAS PERFORMED. APPROXIMATELY, 10 DAYS LATER, DURING SCHEDULED FOLLOW UP, THE PATIENT'S PRE-EXISTING BLOOD PRESSURE WAS NOTED TO BE HIGHER THAN HIS USUAL, AND HIS MEDICATION DOSAGES WERE INCREASED. AN ADDITIONAL MEDICATION WAS ADDED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 20977371 ↗
• InjuryJun 27, 2024Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION OR TORTUOSITY. THE 2.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS INFLATED ONCE BUT PRESSURE WAS NOT SUSTAINED AND THE STENT WAS ONLY DEPLOYING AT THE ENDS. THERE WAS NO MOVEMENT IN THE MID SECTION OF THE STENT. THEN BLOOD WAS NOTED IN THE INFLATION DEVICE, INDICATING A RUPTURE. THE STENT WAS SNARED FROM THE ANATOMY AND A NEW, SAME SIZE XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627413 ↗
• InjuryMay 1, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THE XIENCE SKYPOINT DRUG ELUTED STENT (DES) 2.50 X 38 RX WAS TO BE USED IN THE MID LEFT ANTERIOR DESCENDING (MLAD) LESION. HOWEVER, RESISTANCE WAS FELT AND THE STENT FAILED TO CROSS. THE STENT DISLODGED IN THE RADIAL RECURRENT ARTERY (RRA) AND HAS YET TO BE REMOVED. A DISSECTION OCCURRED WITH SUBSEQUENT POOR FLOW. THE DISSECTION WAS TREATED WITH AN UNKNOWN STENT. THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) AND WAS PLACED ON IMPELLA DUE TO GOING INTO CARDIOGENIC SHOCK AND IS IN INTENSIVE CARE UNIT (ICU). THE PROCEDURE COMPLETED WITH USING A NON-ABBOTT DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Shock; Vascular Dissection

  MAUDE report 19222927 ↗
• InjuryFeb 5, 2024Adverse 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 RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION. THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND DURING POSITIONING A DISTAL END DISSECTION WAS NOTED. THE STENT WAS IMPLANTED; HOWEVER, FURTHER POST DILATATION WAS PERFORMED TO FURTHER TREAT THE DISSECTION. THE DISSECTION WAS RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 18646978 ↗
• MalfunctionJan 9, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS PROVIDED, INDICATING THAT THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475933 ↗
• MalfunctionJul 21, 2023Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 2.50X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED WHEN RESISTANCE WAS MET DUE THE ANATOMY; THEREFORE, THE PHYSICIAN USED EXCESSIVE FORCE TO CROSS THE LESION; HOWEVER, THE STENT FAILED TO CROSS THE LESION AND THE SHAFT WAS NOTED KINKED. THERE WAS RESISTANCE DURING REMOVAL DUE THE ANATOMY. 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 17373630 ↗
• MalfunctionJun 7, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) AFTER REMOVAL FROM THE DISPENSER HOOP, THE HUB OF THE SDS WAS ATTEMPTED TO BE CONNECTED TO THE INDEFLATOR WHEN IT WAS NOTED TO BE CRACKED. ANOTHER XIENCE SKYPOINT WAS USED TO CONNECT TO THE SAME INDEFLATOR AND COMPLETED THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT A PORTION OF THE HUB, IN LINE WITH THE NOTED CRACK, WAS SEPARATED AND NOT RETURNED. THE ACCOUNT CONFIRMED THE SEPARATION AT THE HUB. IT IS UNKNOWN WHEN IT OCCURRED, HOWEVER, IS POSSIBLE THAT THE SEPARATION OCCURRED BEFORE THE DEVICE WAS DELIVERED TO THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080821 ↗
• InjuryFeb 27, 2023Adverse 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 LESION IN THE DISTAL, MID, AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS IMPLANTED IN THE DISTAL LAD ARTERY. THE SECOND XIENCE SKYPOINT STENT, 2.75X38MM, WAS IMPLANTED IN THE MID LAD ARTERY. THE THIRD XIENCE SKYPOINT STENT, 3.0X28MM, WAS IMPLANTED IN THE MID TO PROXIMAL LAD ARTERY. ALL THREE STENTS WERE POST DILATED USING A 2.5X25MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) AT THE DISTAL PART OF THE LESION AND A 3.0X25MM NC TREK NEO BDC AT THE PROXIMAL PART OF THE LESION. ANGIOGRAM WAS USED TO CONFIRM THAT THE STENTS WERE FULLY APPOSED. AT THIS TIME IT WAS NOTED THERE WAS A DISTAL EDGE DISSECTION ON THE MOST DISTAL 2.5X38MM IMPLANTED STENT. AN ADDITIONAL 2.25X18MM XIENCE SKYPOINT STENT WAS ATTEMPTED TO BE USED TO TREAT THE DISSECTION AND CROSSED THE PROXIMAL SEGMENT (3.0X28MM STENT) BUT FAILED TO CROSS THE 2.75X38MM IMPLANTED STENT AND THE STRUTS BECAME FLARED. FURTHER POST DILATATION WAS PERFORMED FOR THE 3 IMPLANTED STENTS PER STANDARD PROCEDURE. A WIGGLE WIRE WAS USED AS A BUDDY WIRE AND ANOTHER 2.25X18MM XIENCE

  Patient problems: Vascular Dissection

  MAUDE report 16444373 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16207107 ↗
• MalfunctionDec 21, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DISTAL RIGHT CORONARY ARTERY (DRCA). THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS NOTED DURING REMOVAL WITH ANATOMY. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE IT WAS COMPLETED WITHOUT TREATMENT. THE WAS 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 16025079 ↗
• MalfunctionAug 4, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH A 2.5MM BALLOON. THEN A 2.5X38MM XIENCE SKYPOINT FAILED TO CROSS THE LESION DUE TO ANATOMY. THERE WAS RESISTANCE MET DURING REMOVAL. THE DISTAL STENT EDGE WAS NOTED TO BE FLARED. A 2.5X33MM NON-ABBOTT 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 15168552 ↗
• MalfunctionJun 24, 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 HEAVILY TORTUOUS, HEAVILY CALCIFIED RIGHT CORONARY ARTERY. AFTER PRE-DILATATION, A 3X38MM XIENCE SKYPOINT FAILED TO CROSS THE LESION DUE TO ANATOMY. THERE WAS RESISTANCE DURING REMOVAL OF THE DEVICE. THEN A 2.5X38MM XIENCE SKYPOINT WAS ALSO ATTEMPTED BUT ALSO FAILED TO CROSS DUE TO ANATOMY. THERE WAS RESISTANCE DURING REMOVAL OF THE DEVICE. IT WAS ALSO NOTED THAT THE DISTAL PART OF THE STENT WAS NOTED TO BE FLARED. THE PROCEDURE WAS SUCCESSFULLY FINISHED WITHOUT ANY TREATMENT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14808563 ↗
• MalfunctionMar 26, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE HEAVILY CALCIFIED AND HEAVILY TORTUOUS, 99% STENOSED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 2.5X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED TO THE LESION AND THERE WAS RESISTANCE WITH THE ANATOMY DURING REMOVAL. 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 13918942 ↗
• MalfunctionFeb 22, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 80% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). DURING ADVANCEMENT OF A 2.5X38MM XIENCE SKYPOINT DRUG ELUTING STENT SYSTEM (DESS), RESISTANCE WAS MET DUE TO THE HEAVY CALCIFICATION AND THE TORTUOSITY OF THE VESSEL. THE STENT MOVED FROM ITS PLACEMENT ON THE BALLOON BUT REMAINED TIGHTLY CRIMPED ON THE BALLOON. THE DESS WAS REMOVED COMPLETE FROM THE VESSEL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581757 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 100% STENOSED. THE 2.5X38MM XIENCE SKYPOINT STENT DELIVERY SYSTEM FAILED (SDS) TO CROSS DUE TO ANATOMY. RESISTANCE WITH ANATOMY WAS ALSO NOTED DURING REMOVAL OF THE SDS. A NON-ABBOT STENT 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 13003947 ↗
• MalfunctionDec 14, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE 90% STENOSED, HEAVILY CALCIFIED, HEAVILY TORTUOUS PROXIMAL CIRCUMFLEX CORONARY ARTERY. THE 2.50X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THERE WAS ALSO RESISTANCE WITH THE ANATOMY DURING INDEPENDENT REMOVAL. 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 13003167 ↗
• MalfunctionDec 9, 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, 90% STENOSED, DE NOVO LESION IN THE FIRST OBTUSE MARGINAL. A 2.5X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED BUT COULD NOT REACH THE TARGET LESION DUE TO THE ANATOMY. THE DES WAS REMOVED WITH RESISTANCE MET FROM THE ANATOMY, AND A NON-ABBOTT STENT 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 12972000 ↗
• InjuryOct 13, 2021Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.50X38MM XIENCE SKYPOINT STENT WAS DEPLOYED HOWEVER POST DEPLOYMENT THE PHYSICIAN FELT THE STENT HAD FRACTURED. AN ADDITIONAL NON-ABBOTT STENT WAS IMPLANTED AS TREATMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624434 ↗
• MalfunctionSep 17, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION AND TORTUOSITY, 100% STENOSIS. THE 2.50X38 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO REACH THE LESION DUE TO THE ANATOMY AND DURING INDEPENDENT REMOVAL, RESISTANCE WAS NOTED WITH THE ANATOMY. THERE WERE NO OTHER ISSUES WITH THE DEVICE NOTED. 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 12492188 ↗
• MalfunctionJun 4, 2021Difficult 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 MILDLY TORTUOUS, MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. AFTER THE LESION WAS PREPPED, A 2.5X38MM XIENCE SKYPOINT STENT FAILED TO CROSS DUE TO ANATOMY AND THE STENT WAS NOTED TO BE FLARED. DURING REMOVAL, RESISTANCE WAS ALSO MET WITH ANATOMY. THE PROCEDURE WAS COMPLETED WITH ANOTHER TWO STENTS. 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 11942394 ↗
• MalfunctionJan 4, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 2.50X38MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TOWARDS THE LESION, WHEN REVERSE BLOOD FLOW INTO THE INDEFLATOR WAS NOTED AND A BALLOON RUPTURE WAS SUSPECTED. THE DEVICE WAS NOT IMPLANTED AND WAS REMOVED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11114914 ↗