XIENCE V 1009542-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648064234), received between Mar 24, 2017 and Apr 13, 2017 — classified as 2 deaths.

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.

• DeathApr 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, A 3.5X12MM XIENCE V STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL/OSTIUM CIRCUMFLEX (CX). THREE OTHER STENTS WERE IMPLANTED IN THE LEFT MAIN, DISTAL CX AND MID RIGHT CORONARY ARTERY (RCA). ON (B)(6) 2016, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHEST PAIN AND PNEUMONIA. PER CORONARY ANGIOGRAPHY, THERE WAS 95% IN-STENT STENOSIS IN THE OSTIAL CX STENT AS WELL AS STENOSIS IN OTHER AREAS OF THE HEART. BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. ON (B)(6) 2016 HAZINESS, A POSSIBLE THROMBUS, WAS NOTED IN THE OSTIAL CX. ANOTHER STENT WAS IMPLANTED AS TREATMENT. THE OBTUSE MARGINAL WAS STENTED AS WELL. THE PATIENT WENT INTO A HYPER-COAGULATED STATE. HEPARIN AND REPRO WERE ADMINISTERED; HOWEVER, A LARGE LEFT VENTRICULAR APICAL THROMBUS WAS NOTED WITH ISCHEMIA. THE PATIENT HAD PROGRESSIVE COAGULOPATHY AND BECAME HYPOTENSIVE. THE CAUSE OF THE HYPER-COAGULATED STATE WAS UNKNOWN. VASOPRESSORS WERE PROVIDED AS TREATMENT. THE PATIENT BECAME SEPTIC AND CARE WAS DISCUSSED WITH THE FAMILY. IT WAS DECIDED TO MAKE THE PATIENT A DO NOT RESUSCITATE (DNR). CARE WAS WITHDRAWN AND ON (B)(6) 2016, THE PATIENT EXPIRED. THERE WAS NO ADDITIONAL INFORMATION PROVI

  Patient problems: Angina; Death; Ischemia; Stenosis; Thrombosis

  MAUDE report 6488952 ↗
• DeathMar 24, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2012 DURING AN ELECTIVE PROCEDURE, THE PATIENT HAD A 2.75 X 24 MM NON-ABBOTT STENT WAS IMPLANTED IN THE POSTEROLATERAL OF THE LEFT CIRCUMFLEX AND A 3.50 X 12 MM XIENCE V STENT IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX. ON (B)(6) 2012, (B)(6) 2014 AND (B)(6) 2015. THE PATIENT HAD FOLLOW-UP VISITS AND NO ISSUES WERE NOTED. ON (B)(6) 2017 THE PATIENT EXPERIENCED TIGHTNESS IN THE CHEST AT HOME AND WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. AFTER ARRIVING AT THE HOSPITAL, THE PATIENT EXHIBITED INCREASING SYMPTOMS OF BRADYCARDIA EVENTUALLY RESULTING IN CARDIOPULMONARY ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS ATTEMPTED SEVERAL TIMES. HOWEVER, DURING THE CPR VENTRICULAR FIBRILLATION (VF) OCCURRED AND DEFIBRILLATION ATTEMPTS WERE MADE BUT THEY WERE IN VAIN. THE PATIENT DIED ON (B)(6) 2017. IN THE OPINION OF THE PHYSICIAN, BASED ON THE CONDITION OF THE PATIENT AND THE CIRCUMSTANCES, THE DEATH WAS CARDIAC DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Bradycardia; Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 6431723 ↗