Resolute Integrity™ RSINT25014UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169037366), received between May 17, 2017 and Jan 22, 2018 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND SEVERELY TORTUOUS DISTAL CX LESION EXHIBITING 85% STENOSIS. THE PATIENT'S ANATOMY WAS DESCRIBED AS MULTIPLE LARGE ANGLE TURNS WITH CALCIUM AND TORTUOUS. NO DAMAGE WAS NOTED TO DEVICE PACKAGING . THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS PRE-DILATED. DURING THE PROCEDURE THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT STENT DEFORMATION IN VIVO DURING POSITIONING OCCURRED. IT WAS REPORTED THAT THE STENT WAS DAMAGED IN THE MIDDLE OD OF THE STENT. NO PATIENT INJURY WAS REPORTED. AS THE PHYSICIAN WAS CONCERNED THAT THERE WAS AN ISSUE WITH THE STENT THEN A 2.5 X 8MM RESOLUTE INTEGRITY STENT WAS THEN SELECTED AND USED TO COMPLETE THE PROCEDURE WITH NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7209742 ↗
• MalfunctionJun 16, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DUE TO AN ACUTE BEND AND CALCIFICATION OF THE TARGET LESION, THE STENT COULD NOT CROSS THE LESION. DUE TO MULTIPLE ATTEMPTS TO POSITION THE STENT, STENT STRUTS GOT DAMAGED. NO PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645981 ↗
• InjuryJun 9, 2017Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT RECEIVED A MEDTRONIC DRUG ELUTING STENT TO THE LEFT MAIN TO RAMUS DURING PCI. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST IMPLANT THE PATIENT WAS ADMITTED WITH CARDIAC SYMPTOMS. IT WAS REPORTED THAT THE PATIENT'S STENT HAD FRACTURED RESULTING IN FAILURE OF THE DEVICE. INTERVENTION WAS PERFORMED. THE DEVICE WAS NOT EXPLANTED. RESTENOSIS WAS NOTED, WHICH WAS TREATED WITH BALLOONING. IT IS REPORTED THAT THE PHYSICIAN COULD NOT DEFINITIVELY CONCLUDE WHETHER THERE WAS A STENT FRACTURE, OR WHETHER THE STENT IN QUESTION WAS A MEDTRONIC STENT. STENT FRACTURE/OCCLUSION NOTED IN THE RAMUS AND THE OCCLUSION OF THE LM TO RAMUS, SUCCESSFULLY TREATED WITH TVR

  Patient problems: Patient Problem/Medical Problem; Stenosis

  MAUDE report 6629620 ↗
• MalfunctionMay 17, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT. NO ISSUES NOTED TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. 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 DURING DELIVERY. NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO POSITION THE STENT IN THE ARTERY, BUT COULD NOT CROSS THE STENT AND IT PUSHED THE GUIDE OUT. THE PHYSICIAN BELIEVED THAT THE STENT MAY HAVE CAUGHT ON THE GUIDE. THE PHYSICIAN BALLOONED THE LESION AND WAS ABOUT TO PUT THE STENT BACK IN AND NOTICED THAT THE STRUTS WERE STICKING UP. IT IS UNKNOWN IF IT CAME OUT OF THE PACKAGE THAT WAY OR IF IT CAUGHT ON THE GUIDE AND DEFORMED THE STENT. ANOTHER RESOLUTE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571575 ↗