XIENCE Skypoint™ 1804250-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648233050), received between Dec 7, 2021 and Mar 6, 2024 — classified as 1 death, 4 injuries, 2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2024Material Rupture; Activation Failure; Material Rupture; Activation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18851789 ↗
• DeathDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS REPORTED THAT THE PATIENT HAD A CAROTID SURGERY ON (B)(6) 2023, WHICH A 7-10/40 ACCULINK STENT AND A 9TX40X136 XACT STENT WERE IMPLANTED WITH NO REPORTED ISSUE. ON (B)(6) 2023, THE PATIENT PRESENTED WITH A STEMI AND AN OCCLUSION IN THE LEFT MAIN WAS OBSERVED. A 2.5X8MM XIENCE SKYPOINT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE PATIENT HAD TO BE INTUBATED POST PROCEDURE AND PATIENT EXPIRED ON (B)(6) 2023. IN THE PHYSICIAN¿S OPINION, THE XIENCE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 18249924 ↗
• InjuryNov 9, 2023Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED, RETURN DEVICE ANALYSIS AND FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THE STENT REMAINED ON THE DELIVERY SYSTEM THE STENT DID NOT DISLODGE; HOWEVER, THE STENT STRUT WAS FLARED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103737 ↗
• InjuryOct 7, 2022Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565773 ↗
• InjuryJun 21, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS RIGHT CORONARY ARTERY. THREE XIENCE SKYPOINT STENT DELIVERY SYSTEMS (2.5X15MM, 2.5X12MM, AND 2.5X08MM) FAILED TO CROSS THE LESION; HOWEVER, A DISSECTION WAS NOTED. IT IS UNKNOWN IF THERE WAS ANY TREATMENT PROVIDED FOR THE DISSECTION. AN UNSPECIFIED STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 14758666 ↗
• InjuryApr 14, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14114143 ↗
• MalfunctionDec 7, 2021Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953674 ↗