XIENCE XPEDITION 1074250-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648162183), received between Apr 10, 2017 and Aug 19, 2020 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Difficult to Remove; Stretched; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: THE STENT REMAINED STUCK IN THE PROTECTIVE SHEATH AND CAME OFF OF THE BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 10427968 ↗
• MalfunctionFeb 13, 2020Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  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: No Consequences Or Impact To Patient

  MAUDE report 9707663 ↗
• 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 9613487 ↗
• MalfunctionSep 27, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2019 TWO XIENCE XPEDITION STENTS, SIZES 2.75 X 38 AND 2.5 X 38 MM, WERE IMPLANTED IN THE CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY; ONE WAS IMPLANTED IN THE PROXIMAL TO MID LAD, THE OTHER WAS IMPLANTED IN THE DISTAL LAD. ON (B)(6) 2019 THE PATIENT HAD CHEST PAIN AND WAS FOUND TO HAVE A NON ST ELEVATION MYOCARDIAL INFARCTION. THERE WAS IN-STENT RESTENOSIS IN THE PROXIMAL TO MID LAD. THIS WAS TREATED WITH A NON-ABBOTT DRUG ELUTING STENT. IN THE DISTAL LAD, THE STENT WAS FRACTURED. THE DISTAL STENT WAS LOCATED IN AN AREA WITH A LARGE AMOUNT OF MOVEMENT BECAUSE IT IS AT A BEND. THE DISTAL STENT WAS PATENT AND DID NOT REQUIRE ANY TREATMENT. THE PATIENT CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131005 ↗
• DeathApr 10, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED, MILDLY TORTUOUS, AND MILDLY CALCIFIED ECCENTRIC LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 2.5X38MM XIENCE XPEDITION STENT WAS IMPLANTED ON (B)(6) 2014. A NON-ABBOTT STENT WAS IMPLANTED ON (B)(6) 2014. NO PATIENT ISSUES WERE NOTED DURING A FOLLOW-UP VISIT ON (B)(6) 2015. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 WITH ACUTE CORONARY SYNDROME AND PRESENTED WITH MYOCARDIAL INFARCTION. THROMBOSIS WAS CONFIRMED IN THE PROXIMAL PART OF THE IMPLANTED XIENCE XPEDITION (IN-STENT). THE THROMBOSIS WAS CONFIRMED THROUGH ANGIOGRAPHY. THE CAUSE OF THROMBOSIS WAS A RUPTURE OF STENOSIS IN THE IMPLANTED STENT. THE ASPIRATION OF THROMBUS WAS PERFORMED AND PERCUTANEOUS CARDIO PULMONARY SUPPORT WAS INTRODUCED. THE PATIENT EXPIRED ON (B)(6) 2017 DUE TO CARDIAC ARREST. ADDITIONALLY, THE DUAL ANTIPLATELET THERAPY WAS NOT CONTINUED SINCE 12-MONTHS OF DOSING PERIOD ENDED. THE REPORTED CAUSE OF DEATH WAS STENT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Death; Myocardial Infarction; Stenosis; Thrombosis

  MAUDE report 6478424 ↗