XIENCE XPEDITION 1074225-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648162046), received between Nov 11, 2016 and Nov 5, 2018 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROXIMAL MARGINAL ARTERY INTERVENTION, DURING DEPLOYMENT OF THE 2.25 X 18 MM XIENCE XPEDITION STENT AT 12 ATMOSPHERE (ATM), THE BALLOON WOULD NOT HOLD PRESSURE AND SLOWLY DEFLATED. THE BALLOON WAS INFLATED TWICE TO ENSURE THE STENT WAS WELL APPOSED TO THE VESSEL WALL AND THE RESULT WAS NOTED AS VERY GOOD. OUTSIDE THE ANATOMY, A MICRO HOLE WAS NOTED IN THE BALLOON AREA. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040394 ↗
• MalfunctionApr 30, 2018Difficult to Remove

  IT WAS REPORTED THE PROTECTIVE SHEATH GOT STUCK ON THE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE TIP AND INNER MEMBER WERE SEPARATED.

  Patient problems: No Patient Involvement

  MAUDE report 7473950 ↗
• InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE XIENCE XPEDITION STENTS (2.25 X 18 MM. 2.25 X 08 MM AND 3.0 X 12 MM) WERE IMPLANTED IN THE RIGHT CORONARY ARTERY ON (B)(6) 2014. ON (B)(6) 2017, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND RESTENOSIS IN THE STENTS WAS FOUND WHICH WAS TREATED WITH TWO NON-ABBOTT STENTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 6374875 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED DE NOVO LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). TWO XIENCE XPEDITION DRUG ELUTING STENTS WERE IMPLANTED. THE PATIENT WAS BROUGHT BACK TO THE LAB THE SAME DAY DUE TO ST ELEVATION AND ANGIOGRAPHY CONFIRMED THROMBOSIS IN THE PROXIMAL 2.25X18MM XIENCE XPEDITION STENT. THE THROMBOSIS WAS TREATED WITH A NON-ABBOTT CATHETER AND INTRACORONARY REOPRO. THE PATIENT WAS A NON-RESPONDER FOR PLAVIX AND WAS NOT ON ASPIRIN AT THE TIME OF THE THROMBOSIS. IT IS POSSIBLE THERE WAS A MECHANICAL EDGE DISSECTION. THE PROXIMAL STENT WAS POST-DILATED AND A LARGER STENT WAS PLACED PROXIMAL WITH GOOD RESULTS. THE PATIENT WILL BE ON TICAGRELOR FOR 12 MONTHS FOLLOWED BY TICAGRELOR AND WARFARIN FOR 6 MONTHS AND FINALLY ASPIRIN AND WARFARIN THEREAFTER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONALLY INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection; Non specific EKG/ECG Changes; Thrombosis

  MAUDE report 6096177 ↗