XIENCE V 1009539-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648063879), received between Aug 12, 2016 and Aug 15, 2016 — classified as 2 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 16, 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.

• InjuryAug 15, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INDEX PROCEDURE DATE WAS (B)(6) 2010. THE PATIENT WAS ADMITTED TO TREAT RESTENOSIS AND AN UNKNOWN XIENCE STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. IN THE SAME PROCEDURE, ANOTHER LESION IN THE OBTUSE MARGINAL BRANCH WITH 100% STENOSIS WAS ALSO TREATED. ON (B)(6) 2010, AND (B)(6) 2011, FOLLOW-UP CORONARY ANGIOGRAPHY (CAG) WAS PERFORMED AND IT WAS CONFIRMED THAT THERE WERE NO ANGINA SYMPTOMS AND THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT). ON (B)(6) 2011 A 2.5X28MM XIENCE V STENT WAS IMPLANTED TO TREAT A LESION IN THE POSTERIOR LATERAL BRANCH WITH 75% STENOSIS AND A DISTAL EDGE DISSECTION OCCURRED. ON (B)(6) 2012 A FOLLOW-UP CAG WAS PERFORMED AND IT WAS CONFIRMED THAT THE PATIENT WAS COMPLIANT WITH DAPT. ON (B)(6) 2012 DAPT WAS TEMPORARILY STOPPED DUE TO A BIOPSY FOR STOMACH CANCER WHERE THE PATIENT WAS TREATED VIA SURGERY AND MEDICATION FOR THE STOMACH CANCER. ON (B)(6) 2012 DAPT WAS RESTARTED AS THE PATIENTS CONDITION BECAME STABLE AFTER THE SURGERY. ON (B)(6) 2013 FOLLOW-UP CAG WAS PERFORMED AND IT WAS CONFIRMED THAT THERE WERE NO ANGINA SYMPTOMS AND THE PATIENT WAS COMPLIANT WITH DAPT. ON (B)

  Patient problems: Intimal Dissection

  MAUDE report 5877094 ↗
• InjuryAug 12, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THREE XIENCE V STENTS WERE IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY, SIZES 2.5 X 28MM, 3.0 X 18MM, 3.0 X 08MM. ON (B)(6) 2011, RESTENOSIS WAS FOUND IN THE LESION. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH PCI FOR RESTENOSIS IN THE 2.5X28 XIENCE V STENT ON (B)(6) 2011. THE PATIENT CONDITION IMPROVED AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2012, RESTENOSIS WAS FOUND AGAIN IN THE LESION. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH A TRIPLE CORONARY ARTERY BYPASS GRAFT SURGERY IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY, THE POSTERIOR-LATERAL BRANCH OF LEFT CIRCUMFLEX CORONARY ARTERY, AND THE ARTERIOVENOUS BRANCH OF THE RIGHT CORONARY ARTERY ON (B)(6) 2012. THE PATIENT CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 5873618 ↗