XIENCE XPEDITION 1074400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162640), received between Mar 9, 2018 and Feb 13, 2020 — classified as 1 death, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 2.5X30 MM TREK DILATATION CATHETER WAS INFLATED THREE TIMES IN THE CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. IT WAS INFLATED AT 14 ATMOSPHERES (ATMS), 20 ATMS AND 18 ATMS WHEN THE TREK RUPTURED. DURING REMOVAL OF THE TREK, THE BALLOON SEPARATED AND REMAINED IN THE ARTERY. ATTEMPTS MADE TO REMOVE/SNARE OUT THE SEPARATED SEGMENT OF THE TREK WERE NOT SUCCESSFUL. A VESSEL PERFORATION OCCURRED IN THE MID LAD DURING USE OF A NON-ABBOTT DILATATION CATHETER, BUT THE PATIENT REMAINED STABLE. THE 2.5X38 MM XIENCE XPEDITION STENT WAS DEPLOYED AT 12 ATMS FOR 15 SEC, THEN 12 ATM FOR 22 SEC, THEN 20 ATM FOR 15 SEC, AND 5 ATM FOR 11 SEC IN THE MID LAD OVER THE SEPARATED TREK BALLOON; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) DID NOT FULLY DEFLATE AND WAS DIFFICULT TO REMOVE FROM THE GUIDE CATHETER, SO THE SDS AND GUIDE CATHETER WERE REMOVED TOGETHER AS A UNIT. THE PATIENT REMAINED STABLE. A 3.5X38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL LAD AND A 4.0X12 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE OSTIAL LEFT MAIN CORONARY ARTERY. A 4.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PREDILATED LEFT MAIN TO LEFT CIRCUMFLEX. AFTER P

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Occlusion

  MAUDE report 9707781 ↗
• MalfunctionMar 9, 2018Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). A PROWATER GUIDE WIRE WAS ADVANCED IN THE VESSEL. PRE-DILATATION WAS PERFORMED. A 4.0 X 18 MM XIENCE XPEDITION STENT WAS DEPLOYED AT THE TARGET LESION; HOWEVER, THE DEFLATED BALLOON COULD NOT BE WITHDRAWN INTO THE GUIDING CATHETER. ALL THE DEVICES WERE REMOVED AS A SINGLE UNIT INTO THE DESCENDING AORTA TO SAFELY APPLY FORCE TO RETRACT THE SDS AND IT WAS REMOVED FROM THE GUIDING CATHETER WITH A LOT OF RESISTANCE. POST-DILATATION WAS ACCOMPLISHED BY USING AN EXCHANGE WIRE AND RE-WIRING OF THE VESSEL WITH GOOD ANGIOGRAPHIC RESULTS. THERE WAS 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 7328405 ↗