XIENCE XPEDITION 1074300-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648162381), received between Jan 23, 2017 and Oct 9, 2020 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS WITH A CHRONIC, TOTAL OCCLUSION (100%) WITHIN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) LESION. PRE-DILATATION WAS PERFORMED. THREE 3.0X38MM XIENCE XPEDITION STENTS WERE IMPLANTED AND A 3.0X18MM XIENCE XPEDITION STENT WAS IMPLANTED WITHOUT A DEVICE ISSUE REPORTED. TIMI FLOW 3 AND 0% RESIDUAL STENOSIS WAS OBSERVED. PLAQUE SHIFT HAD OCCURRED WITHIN A XIENCE STENT AND THE SIDE BRANCH WAS LOST. THE SIDE BRANCH WAS ATTEMPTED TO BE RE-CROSSED UNSUCCESSFULLY. THE PATIENT HAD GONE INTO VENTRICULAR FIBRILLATION, TREATED WITH CARDIOVERSION. DURING OCT IMAGING, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENTS RHYTHM RETURNED TO NORMAL SINUS AND THE EVENT RESOLVED. ELEVATED CARDIAC ENZYMES WERE ALSO OBSERVED WITHOUT ANY TREATMENT REPORTED AND WITHOUT ANY NEW MYOCARDIAL INFARCTION (MI) DIAGNOSED. REPORTEDLY, THE ELEVATED ENZYMES WERE LIKELY DUE TO CARDIAC ARREST ALONG WITH LOSS OF A SIDE BRANCH. THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Cardiac Arrest; Cardiac Enzyme Elevation; Occlusion; Prolapse; Ventricular Fibrillation

  MAUDE report 10656302 ↗
• MalfunctionMar 11, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SHAFT OF A 3.0X38MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) SNAPPED DURING ADVANCEMENT OVER AN UNSPECIFIED GUIDE WIRE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820954 ↗
• MalfunctionJul 19, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED, MODERATELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE PROWATER GUIDE WIRE WAS IN THE DISTAL RCA AND THEN A BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE WAS BROUGHT INTO THE POSTERIOR DESCENDING ARTERY (PDA). THE PDA WAS STENTED ON THE BMWUII GUIDE WIRE WITH A 3.0X38 MM XIENCE XPEDITION STENT, JAILING THE PROWATER GUIDE WIRE. A XIENCE XPEDITION STENT WAS DEPLOYED AT 10 ATMOSPHERES (ATM) FOR 7 SECONDS AND THE GUIDE WIRES WERE EXCHANGED, PUTTING THE PROWATER INTO THE PDA AND THE BMWUII INTO THE STENT STRUTS TO OPEN THE SIDE BRANCH. THE MID RCA WAS THEN STENTED WITH A 3.5X38 MM XIENCE XPEDITION STENT AT 18 ATM FOR 15 SECONDS. AFTER THE PROCEDURE, THE PHYSICIAN NOTED THAT THE PROWATER GUIDE WIRE WAS STRIPPED [PEELED] AND DAMAGED. NO RESISTANCE WAS NOTED DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809169 ↗
• InjuryAug 27, 2018Expulsion; Expulsion

  IT WAS REPORTED THAT IN (B)(6) 2018, THE PROCEDURE WAS PERFORMED USING TWO XIENCE XPEDITION STENTS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION. A 3.0 X 38 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL RCA AND A 3.0 X 18 MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE MID RCA. ON (B)(6) 2018, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME FROM A DE NOVO BLOCKAGE. ANGIOGRAPHY REVEALED THE STENTS HAD 70-80% RESTENOSIS IN THE RCA IN BOTH XIENCE XPEDITION STENTS. BALLOON ANGIOPLASTY WAS PERFORMED TO TREAT THE RESTENOSIS. PER THE PHYSICIAN, THE CAUSE OF THE RESTENOSIS WAS UNDER EXPANSION OF THE STENT. THE LEFT ANTERIOR ARTERY WAS ALSO TREATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 7819670 ↗
• DeathJan 23, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESIONS LOCATED IN THE LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERIES ON (B)(6) 2016. AFTER ABLATION WAS PERFORMED WITH A NON-ABBOTT DEVICE, A PERFORATION OCCURRED. NON-ABBOTT STENTS WERE IMPLANTED TO TREAT THE PERFORATION. THEN, TWO XIENCE XPEDITION (3.0 X 38 MM AND 3.0 X 8 MM) STENTS WERE IMPLANTED. AFTER IMPLANTATION OF THE XIENCE XPEDITION STENTS, BLOOD FLOW WAS DECREASED AND THE PATIENT'S CONDITION CHANGED FOR THE WORSE. IN SPITE OF INTRA-AORTIC BALLOON PUMP (IABP) AND PERCUTANEOUS CARDIO PULMONARY SUPPORT (PCPS) FOLLOWED BY CORONARY ARTERY BYPASS GRAFT (CABG), ON (B)(6) 2016, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS HEART FAILURE DUE TO THE DECREASED BLOOD FLOW CAUSED BY PLAQUE, HOWEVER IT COULD NOT BE CONFIRMED WHEN THE PLAQUE SHIFT OCCURRED; AFTER IMPLANT OF ONE OR BOTH STENTS. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: Death; Ischemia; Prolapse

  MAUDE report 6271745 ↗