XIENCE XPEDITION 1074300-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648162336), received between Aug 9, 2017 and Oct 2, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Advance” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2018Difficult 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 PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT MAIN ARTERY. A 3.0X15MM XIENCE XPEDITION STENT DELIVERY SYSTEM FAILED TO CROSS DUE TO THE ANATOMY; HOWEVER, WHEN AN ATTEMPT TO REMOVE THE SDS WAS MADE IT WAS NOTED THAT THE STENT WAS CAUGHT WITH THE ANATOMY AND THE STENT DISLODGED. THE PHYSICIAN STATED THAT THIS WAS DUE TO THE TIGHT AND CALCIFIED LESION, NOT DUE TO A DEVICE MALFUNCTION. AN UNSPECIFIED BALLOON CATHETER WAS ADVANCED TO COMPRESS THE STENT AGAINST THE ARTERY AND A SECOND UNSPECIFIED STENT WAS DEPLOYED OVER THE CRUSHED STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7927741 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND A 3.0 X 15 MM XIENCE XPEDITION STENT WAS DEPLOYED IN THE CORONARY ARTERY. ON (B)(6) 2017, THE PATIENT WAS MOVED TO THE HOSPITAL BY EMERGENCY VISIT AND HOSPITALIZED WITH CHEST PAIN. THROMBUS (IN-STENT) WAS CONFIRMED BY ANGIOGRAPHY. A THROMBUS SUCTION CATHETER AND EXCIMER LASER WERE USED TO TREAT THE THROMBUS. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Thrombosis

  MAUDE report 6904086 ↗
• InjuryAug 9, 2017Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, ECCENTRIC AND MILDLY CALCIFIED DE NOVO MID RIGHT CORONARY ARTERY THAT WAS 99% STENOSED. THE PATIENT PRESENTED WITH SEVERE CORONARY ARTERY DISEASE IN 3 VESSELS, AN INFERIOR SEGMENT ELEVATED MYOCARDIAL INFARCTION (STEMI), AND THROMBUS WITH A TIMI I FLOW. DURING THE ADVANCEMENT OF A 3.0 X 15 MM XIENCE XPEDITION STENT, EMBOLIZATION OF THROMBUS OCCURRED WITH ST ELEVATION. THEREFORE, THE STENT FAILED TO CROSS THE LESION AND IT WAS REMOVED AND REPLACED WITH A 3.0 X 23 XIENCE XPEDITION STENT TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism; Non specific EKG/ECG Changes

  MAUDE report 6779012 ↗