Resolute Integrity™ RSINT30038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169037205), received between Dec 14, 2016 and Nov 23, 2021 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN A PATIENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION WITH RED SKIN THROUGH WHOLE BODY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 12861287 ↗
• MalfunctionMay 31, 2018Material Deformation; Material Deformation

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE DEVICE WAS INSPECTED BEFORE USE, WITH NO ISSUES NOTED. RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN PULLED OUT IT WAS NOTED THAT THE PROXIMAL PORTION OF THE STENT WAS DAMAGED. IT WAS REPORTED THAT THE STENT MAY HAVE GOTTEN CAUGHT ON THE GUIDE, WHEN REMOVING THE DEVICE FROM THE PATIENT, RESULTING IN THE DAMAGE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556431 ↗
• MalfunctionJan 12, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS LESION WITH 80% STENOSIS IN THE PROXIMAL LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT THE STENT STRUT GOT LIFTED UP. THE PROCEDURE WAS COMPLETED USING A RSINT30034UX DEVICE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185146 ↗
• MalfunctionNov 9, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE LAD. THERE WERE THERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DETACHED/UNRAVELLED FROM THE BALLOON AFTER TRYING TO ADVANCE STENT TO LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTE INTEGRITY DEVICE OF THE SAME SIZE. THE PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012529 ↗
• InjuryOct 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A PATIENT'S SEVERELY TORTUOUS, MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY WHICH EXHIBITED 75% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING OR WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE LESION WAS PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN USED A 6FR NON MDT GUIDE EXTENSION CATHETER TO DELIVER THE STENT AND TRIED MULTIPLE TIMES TO DELIVER THE STENT WITHOUT SUCCESS. THE STENT FAILED TO GET PAST THE SECOND BEND IN THE ARTERY. UPON ATTEMPTING TO REMOVE THE STENT FROM THE LESION, THE STENT BECAME STUCK AND COULD NOT BE RETRIEVED INTO THE GUIDE EXTENSION CATHETER. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS PULLING IT INTO THE GUIDE CATHETER THIS LIKELY CAUSED THE STENT TO BEGIN TO DISLODGE. UPON COMPLETE REMOVAL OF THE DEVICE (REMOVING EVERYTHING AT ONCE) THE STENT WAS NOT ON THE BALLOON. THE DISLODGED STENT

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6983026 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA WHICH WAS TREATED BY TWO RESOLUTE INTEGRITY DRUG ELUTING STENTS- ONE INTO THE MID LAD AND ONE INTO THE DIST LCX. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED NON-ST ELEVATION MYOCARDIAL INFARCTION. THIS WAS TREATED WITH REVASCULARISATION OF THE RCA (NON-TVR). THE PATIENT RECOVERED

  Patient problems: Myocardial Infarction

  MAUDE report 6499464 ↗
• MalfunctionDec 14, 2016Leak/Splash; Leak/Splash

  IT IS REPORTED THAT AN ATTEMPT WAS BEING MADE TO USE RESOLUTE INTEGRITY DEVICE IN A RCA LESION WITH NO CALCIFICATION OR TORTUOSITY. NO DAMAGE WAS NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE BALLOON WOULD NOT HOLD PRESSURE AT 10ATM DURING DEPLOYMENT. IT WAS REPORTED THAT THE BALLOON SEEMED TO BE INTACT AFTER REMOVAL HOWEVER, BLOOD WAS VISIBLE INSIDE. A LEAK WAS SUSPECTED SOMEWHERE WITHIN THE SHAFT. POST DILATION WAS CARRIED OUT WITH A WITH A NC MEDTRONIC BALLOON. NO INJURY WAS CAUSED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6174468 ↗