XIENCE XPEDITION 1074225-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648162022), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2019Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. FOUR UNSPECIFIED STENTS WERE IMPLANTED DURING THE PROCEDURE. THEN A 2.25X12MM XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION BUT VIA ANGIOGRAPHY, BEFORE DEPLOYMENT ATTEMPTS, THE PHYSICIAN COULD NOT SEE THE STENT. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT IMPLANT HAD BEEN FOUND ON THE STERILE TABLE. IT IS SUSPECTED THAT THE STENT DISLODGED DURING PREPARATION PHASE. TWO (2.25X8MM) XIENCE STENTS WERE USED TO SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459262 ↗