Resolute Integrity™ RSINT40022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037229), received between Feb 7, 2017 and Dec 19, 2017 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

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.

• MalfunctionDec 19, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A NON-TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY, EXHIBITING 99% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING. IT WAS DESCRIBED THAT THE LESION WAS PRE-DILATED USING A MEDTRONIC DEVICE (EUPHORA 3.0 X 15) AND THEN THE STENT WOULDN'T CROSS LESION. THE PHYSICIAN PULLED OUT SDS AND INSERTED A NON MEDTRONIC GUIDE EXTENSION CATHETER. IT WAS INFORMED THAT THE PHYSICIAN TRIED TO PASS STENT THROUGH THE NON MEDTRONIC GUIDE EXTENSION CATHETER, BUT STENT WOULDN'T GO THROUGH THE DEVICE COMPLETELY. THE SDS WAS PULLED OUT AND THE STENT WAS INSPECTED; THE STENT WAS DAMAGED, THE PROXIMAL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127922 ↗
• MalfunctionSep 15, 2017Material Deformation; Material Deformation

  IT WAS INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED DISTAL RCA LESION EXHIBITING 80% STENOSIS. THE LESION WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO PACKAGING OR ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTICE. THERE WAS NO RESISTANCE NOTED WHEN LOADING THE DEVICE THROUGH THE 6FR GUIDE CATHETER HOWEVER RESISTANCE WAS FELT WHEN ADVANCING THE DEVICE TO THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND RESISTANCE WAS FELT WHEN IT WAS BEING REMOVED FROM THE BODY. IT IS INDICATED THAT THIS MAY HAVE BEEN DUE TO THE CALCIUM IN THE VESSEL OR THE TIP OF THE GUIDE CATHETER; RESISTANCE WAS NOTED WHEN WITHDRAWING THE DEVICE THROUGH THE GUIDE CATHETER. IT WAS REPORTED THAT FORCE WAS USED WHEN REMOVING THE DEVICE AND AFTER REMOVAL, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING A RESOLUTE INTEGRITY 4.0X18MM STENT. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867911 ↗
• InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A RESOLUTE INTEGRITY RX DRUG ELUTING STENT DEVELOPED REACTION SYMPTOMS LESS THAN A YEAR LATER. THESE INCLUDED ULCERATIVE COLITIS, PAIN SWELLING IN JOINTS, DECREASED ENERGY LEVELS. THE PATIENT ALSO EXPERIENCED ECZEMA WHICH WAS REPORTED TO BE INCREASINGLY GETTING WORSE. THE PATIENT HAD A PATCH TEST REVEALING A NICKEL ALLERGY. PATIENT HAS NO PREVIOUS STENTS IMPLANTED. PATIENT TREATED WITH MEDICATION.

  Patient problems: Reaction

  MAUDE report 6306686 ↗