Resolute Integrity™ RSINT25026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037519), received between Feb 6, 2017 and Nov 16, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionNov 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 60-70% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND 99% IN THE DISTAL RIGHT CORONARY ARTERY (RCA), THE OSTIUM AND MID RCA WAS ALSO REQUIRED TO BE TREATED.. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE RIGHT ARM RADIAL ARTERY. IT WAS STATED THAT PER FLUOROSCOPY THE STENT APPEARED TO HAVE BEEN COMPROMISED DURING INITIAL ADVANCEMENT AGAINST SEVERE DIFFUSE CALCIFICATION AND AN ATTEMPT TO WITHDRAW THE STENT DUE TO NO CROSS FAILED. IT IS POSSIBLE THAT THE PROXIMAL STRUTS CAUGHT ON THE GUIDE LUMEN AND THEREFORE MAKING A WITHDRAWAL THROUGH THE GUIDE AND SHEATH IMPOSSIBLE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10842264 ↗
• MalfunctionFeb 9, 2017Material 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 TORTUOUS PROXIMAL CX LESION EXHIBITING 90% STENOSIS. NO DAMAGE WAS NOTED TO DEVICE PACKAGING AND NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE TARGET LESION. THE PHYSICIAN REMOVED THE DEVICE AND IT WAS NOTED THAT THE STENT STRUT WAS LIFTED UP ON THE DISTAL END. THE PHYSICIAN USED ANOTHER STENT WHICH CROSSED AND DEPLOYED WITHOUT INCIDENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6313570 ↗
• InjuryFeb 6, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS PROXIMAL CX LESION EXHIBITING 80% STENOSIS. NO ISSUES WERE NOTED WITH THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP/ TRAY WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NO DIFFICULTIES REMOVING THE PROTECTIVE SHEATH. STENT INSPECTED POST SHEATH REMOVAL WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OR EXCESSIVE FORCE REQUIRED. IT WAS REPORTED THAT THE PHYSICIAN FELT THE STENT GET CAUGHT ON A PIECE OF CALCIUM WHICH RESULTED IN THE STENT DISLODGING FROM THE DELIVERY BALLOON. THIS OCCURRED BEFORE REACHING THE LESION. THE PHYSICIAN MAINTAINED WIRE POSITION AND WAS ABLE TO USE A REGULAR 2.50 BALLOON TO DEPLOY THE STENT BEFORE IT CAUSED A BLOCKAGE AND USED AN NC BALLOON TO INFLATE THE STENT TO 3.25MM. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6303173 ↗