XIENCE Skypoint™ 1804275-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08717648233142), received between Jul 22, 2021 and Sep 29, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936410 ↗
• InjuryNov 24, 2025Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY THAT IS 98% STENOSED. THE 2.75X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS NOTED TO HAVE DIFFICULTY CROSSING THE LESION DUE TO ANATOMY AND IN-STENT RESTENOSIS OF A PREVIOUS UNSPECIFIED STENT. DURING REMOVAL THE STENT MET RESISTANCE WITH ANATOMY AND THE PREVIOUS IMPLANTED STENT. THE STENT DISLODGED AND A NON-ABBOTT BALLOON AND BUDDY WIRE WERE USED TO CRUSH THE STENT INTO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23633624 ↗
• MalfunctionJun 30, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. A 2.75X12MM XIENCE SKYPOINT DRUG-ELUTING STENT WAS DEPLOYED AT 11 ATMOSPHERES. THE XIENCE SKYPOINT BALLOON WAS THEN USED FOR POST-DILATATION AND RUPTURED. AN UNSPECIFIED BALLOON WAS USED FOR POST-DILATATION. 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 22362525 ↗
• MalfunctionJan 29, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED RESISTANCE WAS MET ADVANCING THE 2.75X12MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) OVER A HI TORQUE FLOPPY GUIDE WIRE. THE SDS WAS UNABLE TO ADVANCE THROUGH THE COPILOT VALVE. THE SDS WAS REMOVED AND REPLACED WITH ANOTHER SAME SIZE SKYPOINT. 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 21264717 ↗
• MalfunctionApr 1, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS HEAVILY TORTUOUS. THE XIENCE SKYPOINT DES 2.75 X 12 RX US FAILED TO CROSS DUE TO THE ANATOMY. A NON-ABBOTT STENT WAS USED AS TREATMENT. WHEN THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE, THE STENT BALLOON CAME OFF WHEN IT WAS REMOVED FROM THE BODY, OUTSIDE THE PATIENT. 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 19014972 ↗
• InjuryMar 1, 2024Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. IT WAS ATTEMPTED TO STENT THE PROXIMAL LAD. THE XIENCE SKYPOINT DES 2.50 X 15 RX STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED BUT RUPTURED AT APPROXIMATELY 9 ATMOSPHERES, LEAVING THE STENT PARTIALLY DEPLOYED. THE SDS AND STENT WERE NOT ABLE TO BE REMOVED, BUT WERE EVENTUALLY SNARED AND REMOVED ALONG WITH THE GUIDE. NO STENT WAS IMPLANTED AND THE PATIENT WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) ONLY. THE PATIENT HAD NO COMPLICATIONS POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822244 ↗
• MalfunctionSep 6, 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 DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH HEAVILY CALCIFIED, TORTUOUS AND 90% STENOSED. THE XIENCE SKYPOINT WAS ADVANCED, BUT FAILED TO REACH THE LESION DUE TO THE ANATOMY. DURING REMOVAL, RESISTANCE WAS NOTED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366797 ↗
• MalfunctionMay 23, 2022Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE POSTERIOR LEFT VENTRICULAR ARTERY WITH HEAVY CALCIFICATION. THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCING BUT THE DEVICE FAILED TO CROSS DUE TO THE HEAVY CALCIFICATION. THEREFORE, THE SDS WAS REMOVED AND A GUIDELINER WAS ADVANCED. THE SDS WAS ABLE TO BE RE-ADVANCED THROUGH THE GUIDELINER AND THE STENT CROSSED THE LESION. HOWEVER DURING THE FIRST INFLATION, AT 8 ATMOSPHERES, THE BALLOON WOULD NOT HOLD PRESSURE AND STARTED LOSING PRESSURE. DESPITE THIS, THE STENT WAS DEPLOYED AS INTENDED TO TREAT THE TARGET LESION. POST DILATATION WAS THEN PERFORMED WITH A 2.5X12 NC TREK BALLOON WITHOUT ISSUES. HOWEVER, AFTER THE PROCEDURE A DISSECTION WAS NOTED IN THE MID RIGHT CORONARY ARTERY TO THE OSTIAL. UNSPECIFIED STENTS WERE DEPLOYED TO COVER THE DISSECTION, ENDING THE PROCEDURE. NO OTHER ISSUES REPORTED. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR SURGERY CONSULTATION DUE TO THE ASCENDING AORTA DISSECTION. PER THE PHYSICIAN, IT WAS CONFIRMED THAT THE XIENCE SKYPOINT AND NC TREK DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION RATHER IT IS SUSPECTED THAT THE GUIDE WIRE OR GUIDELINER WERE CONTRIBUTING FACTORS OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14479354 ↗
• InjuryNov 17, 2021Material Rupture; Difficult or Delayed Activation; Material Rupture; Difficult or Delayed Activation

  IT WAS REPORTED THAT THIS WAS A PROCEDURE TO TREAT THE PROXIMAL RIGHT CORONARY ARTERY. A 2.75X12MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE, BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES AFTER THE FIRST INFLATION. AN NC TREK BALLOON WAS ADVANCED TO HELP FULLY APPOSE THE STENT AGAINST THE VESSEL WALL. THE STENT WAS ABLE TO BE ULTIMATELY DEPLOYED/ APPOSED IN THE TARGET LESION. THE DELIVERY SYSTEM 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12828835 ↗
• MalfunctionAug 24, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS HEAVILY CALCIFIED AND NON-TORTUOUS. THE XIENCE SKYPOINT WAS ADVANCED TO THE LESION WITHOUT ISSUE. WHEN PULLING BACK TO POSITION, THE STENT DELIVERY SYSTEM BECAME STUCK IN THE CALCIFICATION. THE ENTIRE DEVICE WAS REMOVED AS A UNIT WITH NO HARM TO THE PATIENT. THE PATIENT WILL BE RE-SCHEDULED FOR ALTERNATIVE TREATMENT. 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 12363567 ↗
• MalfunctionJul 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI) AND THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE 2.75X12 MM XIENCE SKYPOINT STENT WAS PLACED. THE BALLOON WAS INFLATED ONCE AT 5 TO 6 ATMOSPHERES (ATM) FOR 5 SECONDS AND RUPTURED. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT RESISTANCE AND THE STENT WAS CONFIRMED WITH ANGIOGRAPHY TO BE DEPLOYED. POST-DILATATION WAS PERFORMED ABOUT 3 TIMES WITH A 2.75X10MM BALLOON AND IT WAS CONFIRMED WITH IVUS THAT THE STENT WAS COMPLETELY APPOSED AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE STENT EASILY CROSSED AND WAS APPOSED AS IT WAS SHORT LENGTH STENT. 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 12214891 ↗