XIENCE Skypoint™ 1804325-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08717648233326), received between Aug 31, 2021 and Jul 11, 2024 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 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 DISTAL LEFT CIRCUMFLEX ARTERY THAT IS 90% STENOSED. ABLATION WAS PERFORMED AND A 2.75X10MM BALLOON WAS USED TO PRE-DILATE THE LESION SEVERAL TIMES. A 3.25X18MM XIENCE SKYPOINT WAS ADVANCED TO THE LESION; HOWEVER, RESISTANCE WAS FELT WITH ANATOMY. WHEN ATTEMPTING TO DEPLOY THE STENT THE STENT BALLOON RUPTURED AT 6 ATMOSPHERES. THE STENT REMAINED STATIONARY ON THE DELIVERY SYSTEM AND WAS REMOVED. A 2.75X10MM BALLOON PERFORMED ADDITIONAL DILATATION AND A 3.0X18MM XIENCE SKYPOINT WAS DEPLOYED. A 3.25X12MM NC TREK NEO WAS USED FOR POST DILATATION TO 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 19723690 ↗
• MalfunctionDec 23, 2023Material Rupture; Activation Failure; Material Rupture; 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. ROTABLATION WAS PERFORMED AND PRE-DILATATION WITH A 3.0X15 MM NON-ABBOTT BALLOON WAS PERFORMED AND THEN THE 3.25X18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 10 ATMOSPHERES AND FAILED TO DEPLOY THE STENT. THE STENT WAS STILL ON THE BALLOON SO THE ENTIRE SDS WAS REMOVED FROM THE ANATOMY. MORE DILATATION WAS PERFORMED WITH THE 3.0X15 MM BALLOON AND A 3.0X18 MM XIENCE SKYPOINT STENT WAS DEPLOYED SUCCESSFULLY. POST DILATATION WAS PERFORMED WITH A 3.25X12 MM NC TREK BALLOON 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 18389785 ↗
• MalfunctionFeb 25, 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 IN THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH 99% STENOSIS, HEAVY CALCIFICATION AND HEAVY TORTUOSITY. THE 3.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT AND FAILED TO CROSS THE LESION. THERE WAS RESISTANCE WITH THE LESION DURING REMOVAL. THE SDS WAS REMOVED INDEPENDENTLY. A NON-ABBOTT DEVICE 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 16441053 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. ANGIOMAX WAS PROVIDED PRE-PROCEDURE. FOLLOWING, A 3.25X18MM XIENCE SKYPOINT STENT WAS IMPLANTED WITHOUT ISSUES REPORTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN RECOVERY. 600 MG OF PLAVIX HAD BEEN PROVIDED PER PROTOCOL. APPROXIMATELY 30 MINUTES LATER, THE PATIENT HAD BECOME DIAPHORETIC, DYSPNEIC, AND HAD ANGINA. IMAGING WAS PERFORMED AND THE XIENCE SKYPOINT STENT HAD OCCLUDED WITH THROMBUS. AS TREATMENT , THREE ADDITIONAL XIENCE SKYPOINT STENTS WERE IMPLANTED. THE EVENT RESOLVED AND DID NOT REQUIRE PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION AS PROVIDED REGARDING THIS ISSUE.

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

  MAUDE report 12836052 ↗
• MalfunctionSep 1, 2021Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE STYLET WAS REMOVED FROM THE XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WITH SOME RESISTANCE. AFTER REMOVAL, THE SHAFT OF THE SDS FRACTURED. ANOTHER XIENCE SKYPOINT WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406921 ↗
• MalfunctionAug 31, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. THE 3.25X18MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED; HOWEVER, RESISTANCE WAS MET WITH ANATOMY AND THE DEVICE FAILED TO CROSS. ADDITIONALLY, RESISTANCE WAS NOTED WITH ANATOMY DURING REMOVAL OF THE DEVICE. A NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE 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 12392165 ↗