Resolute Integrity™ RSINT40012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037311), received between May 2, 2017 and Aug 12, 2020 — classified as 1 death, 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 18, 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.

• DeathAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, TWO RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS. IT WAS REPORTED THAT THE PATIENT DECEASED 5 YEARS POST IMPLANTATION OF THE RESOLUTE INTEGRITY STENTS. IT WAS STATED THAT THE CAUSE OF DEATH WAS CHOLECYSTITIS.

  Patient problems: Death; Inflammation

  MAUDE report 10395004 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT IMPLANTED. APPROXIMATELY ONE WEEK POST IMPLANTATION THE PATIENT EXPERIENCED HIVES ON THEIR HANDS. THE PATIENT HAS BEEN TREATED WITH ANTIHISTAMINES HOWEVER THE HIVES STILL PERSIST AND ARE GETTING PAINFUL. PATIENT ALSO TAKES PLAVIX AND LIPITOR AND IS NOT AWARE OF ANY ALLERGIES THEY MAY HAVE. PATIENT SPECIFICALLY ASKED ABOUT THE ZOTAROLIMUS ON THE STENT AND WAS INFORMED BY TECHNICAL SERVICES THAT THE DRUG COMPLETELY ELUTES WITHIN 180 DAYS.

  Patient problems: Reaction; Urticaria

  MAUDE report 7062564 ↗
• InjuryMay 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN IMPLANTED ONE RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT CHEST PAIN EXPERIENCED BY THE PATIENT. IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE CHEST PAIN DUE TO A SMALL EDGE DISSECTION. THIS WAS TREATED BY IMPLANTATION OF A SECOND RESOLUTE INTEGRITY DRUG ELUTING STENT.

  Patient problems: Intimal Dissection

  MAUDE report 6536321 ↗