XIENCE XPEDITION 1074350-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648162572), received between Jul 13, 2017 and Oct 19, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionOct 19, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.50 X 33 MM XIENCE XPEDITION RX STENT DELIVERY SYSTEM (SDS), THE SDS WAS REMOVED FROM THE DISPENSER COIL LOOP AND IT WAS NOTED THAT THE HUB BROKE OFF THE SHAFT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6963603 ↗
• MalfunctionJul 13, 2017Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, 90% STENOSED, 30MM-LONG LESION IN THE MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER CROSSING THE LESION WITH A 014 HI-TORQUE (HT) VERSATURN F 190 HC GUIDE WIRE, A 2.5MM NON-ABBOTT BALLOON DILATATION CATHETER WAS ADVANCED OVER THE VERSATURN AND PRE-DILATATION WAS PERFORMED. A 3.5X33MM RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED OVER THE VERSATURN, BUT, PRIOR TO EXITING THE GUIDING CATHETER, RESISTANCE WAS MET BETWEEN THE XIENCE XPEDITION AND THE VERSATURN. WHEN ATTEMPTING TO RETRACT THE XPEDITION OVER THE VERSATURN, RESISTANCE WAS ALSO FELT BETWEEN THESE TWO DEVICES. THUS, BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. A NON-ABBOTT GUIDE WIRE WAS ADVANCED, FOLLOWED BY ADVANCEMENT AND DEPLOYMENT OF A 3.5X33MM NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712728 ↗