Resolute Integrity™ RSINT30018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169037151), received between Apr 4, 2017 and May 27, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionMay 27, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND THAT A STRUT OF THE STENT WAS OBSERVED TO BE FRAYED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8644115 ↗
• MalfunctionJan 7, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A NON CALCIFIED AND NON TORTUOUS PROXIMAL RCA LESION. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS REPORTED THAT THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT AFTER THE DEVICE ENTERED THE PATIENT'S BODY, IT WAS NOTED THAT THE STENT WAS FRACTURED. THE STENT WAS NEVER DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT. A NON-MEDTRONIC STENT WAS THEN USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221508 ↗
• MalfunctionJun 14, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE PROXIMAL LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN TAKEN OUT TO USE A GUIDE LINER THE STENT WAS NOTED TO BE DEFORMED. ANOTHER RESOLUTE INTEGRITY OF THE SAME SIZE WAS THEN USED. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7599984 ↗
• MalfunctionFeb 16, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS FRAYED. THIS OCCURRED IN VIVO AFTER BALLOON ANGIOPLASTY. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7276039 ↗
• MalfunctionJun 23, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DEVICE. IT WAS A VERY TIGHT CALCIFIED, LAD/DIAG LESION . THE LESION LOOKED TO BE CONTAINED TO MOSTLY DIAG. THE LESION WAS NOT PRE-DILATED. THE FIRST STENT, A 2.75 X 18MM RESOLUTE WAS DEPLOYED IN THE DIAG INTO THE LAD. THERE WAS PLAGUE SHIFT INTO THE LAD. A 3.0 X 18 MM WAS ATTEMPTED TO BE DEPLOYED IN THE MID LAD- THOUGH THE DIAG STENT. THE PHYSICIAN REPORTED THAT THE STENT MUST HAVE GOT CAUGHT ON THE DIAG STENT. THEY REMOVED THE STENT AND SAW STRUT DISRUPTION. A NEW STENT; 3.0 X 26 MM RESOLUTE INTEGRITY WAS ADVANCED AND DEPLOYED IT IN THE MID LAD WITH NO ISSUES. BOTH LAD AND DIAG HAD A GREAT ENDING RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6662691 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RESOLUTE INTEGRITY STENT IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAS BE NAUSEOUS ON AND OFF SINCE THE PROCEDURE.

  Patient problems: Reaction

  MAUDE report 6546933 ↗
• MalfunctionApr 4, 2017Material Deformation; Material Deformation

  IT IS REPORTED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS BEING USED IN THE CX. IT IS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PATIENT THE STENT STRUTS WERE DEFORMED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456040 ↗