XIENCE XPEDITION 1074225-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648162060), received between Mar 31, 2017 and Jan 21, 2020 — classified as 1 death, 6 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT A CORONARY PROCEDURE, TREATING A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). THREE XIENCE XPEDITION STENTS (2.25 X 28 MM, 2.5 X 38 MM, 3.0 X 18MM) WERE IMPLANTED. ON (B)(6) 2019, 100% RESTENOSIS WAS NOTED IN THE 2.5 X 38 MM XIENCE XPEDITION STENT IN THE MID RCA. ON (B)(6) 2019, 100% RESTENOSIS WAS NOTED IN THE 2.25 X 28 MM XIENCE XPEDITION STENT IN THE DISTAL RCA. BALLOON ANGIOPLASTY WAS PERFORMED ON (B)(6) 2019 IN THE MID AND DISTAL RCA. THE PATIENT CONDITION RESOLVED ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 9613491 ↗
• DeathJul 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, A 2.25X28MM XIENCE XPEDITION WAS PLACED ATRIOVENTRICULAR IN THE RIGHT CORONARY ARTERY (RCA) TO TREAT A DISSECTION, A 2.5X38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE DISTAL RCA, AND A 3.0X23 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL RCA TO TREAT A DISSECTION. ON AN UNKNOWN DATE, ESTIMATED AS (B)(6) 2015, 100% RESTENOSIS WAS NOTED IN THE ATRIOVENTRICULAR RCA WHERE THE 2.25 X 28 MM XIENCE WAS IMPLANTED. THE RESTENOSIS WAS NOT TREATED AS THE PATIENT HAD NO SYMPTOMS. ON (B)(6) 2017, THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR PNEUMONIA AND THE PATIENT EXPIRED. PER PHYSICIAN, THE CAUSE OF DEATH IS NOT KNOWN AND THE RELATIONSHIP TO THE DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Death

  MAUDE report 7659951 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED WITH ASYMPTOMATIC ISCHEMIA. ON (B)(4)2014, CORONARY INTERVENTION WAS PERFORMED. BALLOON ANGIOPLASTY WAS PERFORMED AND A 2.25 X 28 MM XIENCE XPEDITION STENT AND A 2.75 X 8 MM XIENCE XPEDITION STENT WERE IMPLANTED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED IN THE FIRST DIAGONAL BRANCH OF THE LAD. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. RE-STENOSIS WAS NOTED ON (B)(6) 2017, IN THE 2.25 X 28 MM XIENCE XPEDITION STENT AND IN A NON-TARGET VESSEL. REVASCULARIZATION WAS PERFORMED ON (B)(6) 2017, AND A DRUG ELUTING STENT WAS IMPLANTED AT THE TARGET LESION. BALLOON ANGIOPLASTY WAS PERFORMED IN THE NON-TARGET VESSEL. THE PATIENT CONDITION RESOLVED ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7184633 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, AFTER PRE-DILATATION, A 2.25X28 MM AND 2.75X8 MM XIENCE XPEDITION STENT WAS IMPLANTED IN MID AND PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). ON (B)(6) 2016, THE PATIENT EXPERIENCED ACUTE CORONARY SYNDROME. RESTENOSIS WAS FOUND IN THE 2.25X28 MM XIENCE XPEDITION STENT AND A NON-TARGET LESION. PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH A DRUG ELUTING STENT WAS PERFORMED IN THE STENT AND BALLOON ANGIOPLASTY WAS PERFORMED IN THE NON-TARGET LESION. THE PATIENT RECOVERED ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Stenosis

  MAUDE report 6574188 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, THREE XIENCE XPEDITION STENTS (2.25X28MM, 2.5X38MM, 3.0X18MM) WERE SUCCESSFULLY IMPLANTED IN THE CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA) LESION. ON (B)(6) 2015, IT WAS CONFIRMED THERE WAS NO ISSUE WITH ANY STENT AND THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT). ON (B)(6) 2015, IT WAS CONFIRMED THERE WAS NO ISSUE WITH ANY DEVICE AND THE PATIENT HAD STOPPED TAKING CLOPIDOGREL. ON (B)(6) 2016, TARGET LESION RESTENOSIS OF THE MID RCA, 2.25X28MM XIENCE XPEDITION STENT, WAS NOTED. CLOPIDOGREL WAS PRESCRIBED AGAIN. ON (B)(6) 2016, BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT AND THE CONDITION IMPROVED. PER PHYSICIAN, THE RESTENOSIS WAS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE STENT PROCEDURE AND NOT RELATED TO THE DAPT MEDICATIONS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED REGARDING THIS DEVICE ISSUE.

  Patient problems: Stenosis

  MAUDE report 6491011 ↗
• InjuryApr 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2014, XIENCE XPEDITION 2.25 X 28 MM AND A 2.25 X 23 MM STENTS WERE IMPLANTED IN THE RESTENOSED PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA) LESION. THE PATIENT WAS ON DUAL ANTI-PLATELET THERAPY (DAPT) CONSISTING OF ASPIRIN 100 MG/DAY ONGOING FROM PRIOR TO THE INDEX PROCEDURE, CLOPIDOGREL 75 MG/DAY FROM PRIOR TO THE INDEX PROCEDURE TO (B)(6) 2016 AND PRASUGREL 3.75 MG/DAY ONGOING FROM (B)(6) 2016. ON (B)(6) 2015, RESTENOSIS OF THE XIENCE XPEDITION 2.25 X 28 MM STENT WAS NOTED AND WAS REPORTED ACCORDINGLY ON 12/22/2015. ON (B)(6) 2016, RESTENOSIS OF THE XIENCE XPEDITION 2.25 X 28 MM STENT IN RCA WAS NOTED. THE RESTENOSED LESION WAS TREATED WITH BALLOON ANGIOPLASTY ON (B)(6) 2016 AND THE PATIENT CONDITION WAS IMPROVED ON (B)(6) 2016. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6477305 ↗
• InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 THE 2.25X28 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) AND THE 3.5X38MM XIENCE ALPINE STENT WAS IMPLANTED IN THE PROXIMAL LAD. AT THE EIGHT-MONTH FOLLOW-UP VISIT ON (B)(6) 2015, RESTENOSIS WAS FOUND IN THE NON-TARGET LESION (NO XIENCE STENT WAS IMPLANTED) VIA CORONARY ANGIOGRAPHY. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION ON (B)(6) 2015 AND A DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD. AT THE ONE YEAR-FOLLOW-UP, ON (B)(6) 2016, THE PATIENT WAS NOTED TO HAVE HEPATOCELLULAR CARCINOMA SINCE (B)(6) 2015. IN (B)(6) 2016, THE PATIENT DIED FROM HEPATOCELLULAR CARCINOMA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 6450966 ↗