XIENCE Skypoint™ 1804350-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08717648233371), received between Sep 20, 2021 and Apr 16, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 3.5X8 MM XIENCE SKYPOINT STENT WAS NOT CRIMPED AT THE STENT MARKERS WHEN REMOVED FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899412 ↗
• InjuryOct 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2022, ONCE 2.5X08MM XIENCE SKYPOINT WAS IMPLANTED IN THE PROXIMAL DIAGONAL, 3.5X23MM, 3.5X12MM, 3.5X15MM XIENCE SKYPOINTS IMPLANTED IN PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). ANOTHER 3.0X23, 3.0X12MM AND 3.5X08MM XIENCE SKYPOINTS WERE IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITHOUT ISSUE. HOWEVER, IN (B)(6) 2025, THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN AND DIZZINESS. THEREFORE, A STRESS TEST AND ANGIOGRAM REVEALED THE MID RCA AND MID LAD ARE OCCLUDED. PATIENT IS AWAITING BYPASS SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Obstruction/Occlusion

  MAUDE report 23270463 ↗
• InjuryAug 26, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.50X8MM XIENCE SKYPOINT RX DRUG ELUTING STENT (DES) WAS ADVANCED; HOWEVER, RESISTANCE WAS NOTED DUE TO THE TORTUOSITY OF THE LESION AND THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS CRUSHED USING A BALLOON AND ANOTHER XIENCE SKYPOINT WAS DEPLOYED TO EMBED THE STENT TO THE VESSEL WALL. A CLINICAL DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20064498 ↗
• InjuryJul 1, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A VERY CALCIFIED LESION IN THE CIRCUMFLEX CORONARY ARTERY. THE 3.50 X 08MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON-ABBOTT 7FR. EXTRA-BACKUP CATHETER 3.5 GUIDING CATHETER, WITH RESISTANCE FELT FROM A POSSIBLE GUIDING CATHETER KINK OR A SMALL LUMEN. THE SDS CONTINUED TO BE ATTEMPTED TO BE ADVANCED UNTIL IT WAS DECIDED TO BE REMOVED. DURING WITHDRAWAL, THE STENT DISLODGED INTO THE OSTIAL OF THE CIRCUMFLEX CORONARY ARTERY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO SNARE THE STENT, AND THE STENT FLOATED INTO THE DIAGONAL CORONARY ARTERY. THE STENT WAS WIRED AND TWO BALLOONS FROM ANOTHER MANUFACTURER, A 1.5MM AND A 2.0MM, WERE USED TO DEPLOY THE STENT IN THE DIAGONAL ARTERY IN HEALTHY TISSUE. THE CIRCUMFLEX ARTERY WAS OPTED TO NOT BE TREATED AS THE PATIENT HAD MULTIPLE DISEASED ARTERIES, AND AN UNSPECIFIED STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THERE WAS NO ADVERSE PATIENT SEQUALAE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19646712 ↗
• MalfunctionOct 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, HEAVILY TORTUOUS, 75% STENOSED LESION IN THE MID LEFT CIRCUMFLEX (MCX) ARTERY. A 3.5X08MM 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 FROM THE ANATOMY AND A NON-ABBOTT DEVICE 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 15574734 ↗
• MalfunctionJul 11, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HIGHLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 3.5X8 XIENCE SKYPOINT FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL, RESISTANCE WITH THE ANATOMY WAS ALSO MET. THE DEVICE WAS ABLE TO BE REMOVED AND ANOTHER DEVICE 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 14982382 ↗
• InjuryMay 10, 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 PRESENTED DUE TO EXPERIENCING AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) IN THE RIGHT CORONARY ARTERY (RCA). THREE XIENCE SKYPOINT STENTS WERE IMPLANTED, A 3.50X33MM, 3.50X8MM AND A 4.00X18MM. ON (B)(6) 2022, THE PATIENT WAS RE-HOSPITALIZED TO TREAT A DIFFERENT VESSEL; HOWEVER, IT WAS NOTED THAT THE THREE STENTS WERE OCCLUDED WITH THROMBUS. THEREFORE, ADDITIONAL STENTS WERE IMPLANTED TO TREAT THE THROMBOSIS. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14349962 ↗
• MalfunctionApr 20, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY. THE 3.5X08MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL THE SDS MET RESISTANCE WITH ANATOMY. A NEW 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 14162296 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X8MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED WITHOUT ISSUE AND IMPLANTED AT THE TARGET LESION. A 4X12MM NON-ABBOTT NC BALLOON WAS USED TO POST DILATATE THE STENT AT 14 ATM, AFTER WHICH, THE STENT STRUT APPEARED TO LOOK BROKEN UNDER IMAGING. IT IS THE PHYSICIAN¿S OPINION THAT THE ANGULATION OF THE VESSEL MAY HAVE CAUSED OR CONTRIBUTED TO THE STENT DAMAGE. NO FURTHER TREATMENT WAS PROVIDED, AND THE PROCEDURE WAS COMPLETED AT THAT POINT. 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 12806926 ↗
• MalfunctionSep 20, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). A 3.5X08MM XIENCE SKYPOINT DRUG ELUTING STENT (DES) WAS ADVANCED TO THE LESION AND INFLATED BUT THE BALLOON RUPTURED ON THE FIRST INFLATION TO 12 ATMOSPHERES (ATM). THE DES WAS REMOVED AND A NEW, SAME SIZE XIENCE SKYPOINT DES 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 12503068 ↗