XIENCE XPEDITION 1074275-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648162268), received between Sep 18, 2017 and Sep 18, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionSep 18, 2017Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT A 2.75 X 28 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WOULD NOT CROSS. UPON REMOVAL OF THE SDS FROM THE GUIDE CATHETER, ONE OF THE STENT STRUTS WAS FOUND TO BE BENT. ANOTHER XIENCE SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. ADDITIONAL INFORMATION RECEIVED STATES: THE STENT WENT INTO THE GUIDING CATHETER SMOOTHLY, BUT WHEN IT WAS BEING REMOVED, RESISTANCE WAS MET AT THE ROTATING HEMOSTATIC VALVE, BUT IT PASSED THROUGH. WHEN THE SDS WAS REMOVED, THE STENT DAMAGE WAS OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6872825 ↗