XIENCE PRIME 1011733-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648177187), received between Feb 9, 2017 and Jul 17, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, A 3.5X28MM AND A 3.0X33MM XIENCE PRIME STENT WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. ON (B)(6) 2017, NEW, 100% RESTENOSIS WAS NOTED IN THE LAD XIENCE PRIME STENTS AND 60% RESTENOSIS WAS OBSERVED IN THE LEFT CIRCUMFLEX CORONARY ARTERY, UNSPECIFIED STENT. MEDICATIONS WERE PROVIDED AND BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT AND THE PATIENT'S CONDITION IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Stenosis

  MAUDE report 7696207 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED WITH ISCHEMIA. A CORONARY STENTING PROCEDURE WAS PERFORMED ON (B)(6) 2013, WITH IMPLANTATION OF A 3.0 X 33 MM XIENCE PRIME STENT AND A 3.5 X 28 MM XIENCE PRIME STENT IN THE LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2016, THE PATIENT EXPERIENCED A SERIOUS EPISODE OF ISCHEMIA AND IN-STENT RESTENOSIS WAS NOTED WITHIN THE XIENCE STENTS. ADDITIONALLY, A NEW AREA OF STENOSIS WAS NOTED IN THE CIRCUMFLEX ARTERY. ON (B)(6) 2016, ANGIOPLASTY WAS PERFORMED, USING A DRUG COATED BALLOON, TO TREAT THE RESTENOSIS OF THE XIENCE PRIME STENTS. INTERVENTION WAS PERFORMED, TREATING THE CIRCUMFLEX ARTERY, WITH IMPLANTATION OF AN UNSPECIFIED DRUG ELUTING STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Ischemia; Stenosis

  MAUDE report 7034556 ↗
• InjuryFeb 9, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED WITH A STENOSED BYPASS GRAFT. A 3.0X33 XIENCE PRIME STENT WAS SUCCESSFULLY IMPLANTED ALONG WITH 2 NON-ABBOTT STENTS IN THE PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA) TOTALLY OCCLUDED LESION. ON (B)(6) 2013, THE PATIENT PRESENTED FOR A FOLLOW-UP CORONARY ANGIOGRAM WITHOUT ANY CLINICAL SYMPTOMS. APPROX 41.63% STENOSIS WAS NOTED IN THE 3.0X33 XIENCE PRIME STENT. ADDITIONAL BALLOON ANGIOPLASTY WAS PERFORMED AS TREATMENT. MEDICATIONS WERE CHANGED. ON (B)(6) 2016 FOLLOW-UP CORONARY ANGIOGRAPHY WAS PERFORMED. IT WAS CONFIRMED THAT THERE WAS NO ISSUE WITH ANY INDEX PROCEDURE STENT. ON (B)(6) 2016, SEPSIS CAUSED BY ACUTE GALLBLADDER DISEASE WAS DIAGNOSED. NO TREATMENT WAS PROVIDED AND LATER THAT DAY, THE PATIENT EXPIRED. PER THE PHYSICIAN, THE DEATH WAS NOT RELATED TO THE IMPLANTED STENTS OR STUDY PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT.

  Patient problems: Death; Stenosis

  MAUDE report 6316286 ↗