Resolute Integrity™ RSINT22530UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169037335), received between Jan 31, 2017 and Sep 13, 2018 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2018Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE LAD. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. IT WAS REPORTED THAT DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT AND THE STENT WAS NEVER DEPLOYED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872029 ↗
• MalfunctionFeb 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE INTEGRITY RX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED IN A PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. A GUIDELINER WAS USED BUT IT STILL DID NOT AID DELIVERY. WHILE BEING REMOVED FROM THE PATIENT, THE STENT WAS PULLED BACK INTO THE GUIDELINER AND THE STENT WAS REPORTED TO HAVE FELL OFF THE DELIVERY SYSTEM BALLOON. THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7276102 ↗
• InjuryNov 27, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION EXHIBITING MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. THE LESION WAS SITUATED IN THE MID/DISTAL LAD. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO ISSUES WERE ENCOUNTERED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED POST-REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS NOTED THAT THE STENT WOULD NOT ADVANCE THROUGH PREVIOUSLY DEPLOYED STENTS TO THE DISTAL LESION. WHEN IT WAS REALISED THAT THE STENT WOULD NOT ADVANCE ANY FURTHER, THE STENT WAS PULLED BACK FOR REMOVAL. THE STENT SUBSEQUENTLY DISLODGED, AND WAS NOT REMOVED. POST-DISLODGEMENT, A BALLOON WAS USED TO CRUSH THE DISLODGED STENT UP AGAINST THE MID LAD VESSEL WALL. NO FURTHER PATIENT INJURY WAS REPORTED POST PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7058417 ↗
• MalfunctionJun 22, 2017Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO IMPLANT THE RESOLUTE INTEGRITY RX STENT IN A PATIENT'S MID CIRCUMFLEX (CX) ARTERY WHICH HAD MODERATE TORTUOSITY, CALCIFICATION AND 80% STENOSIS. NO REPORTED DAMAGE TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED DURING PREP. IT WAS REPORTED THAT DURING THE PROCEDURE, NEGATIVE PRESSURE WAS PULLED RIGHT BEFORE INFLATION, WHEN THE DEVICE WAS POSITIONED AT THE LESION, AND BLOOD WAS NOTICED IN THE SALINE MIXTURE (BALLOON LEAK). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT NOR WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. DEVICE WAS NEVER IMPLANTED. NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING A RESOLUTE 2.25 X 30MM RX STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6661056 ↗
• InjuryFeb 22, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LAD LESION EXHIBITING 100% STENOSIS (CTO). NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING OR ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP / TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE USED. STENT DISLODGEMENT WAS REPORTED TO HAVE OCCURRED DURING ADVANCEMENT AND PULL BACK IN THE LESION. IT WAS REPORTED THAT THE CTO WAS FIXED, BUT THAT THE DISLODGED STENT ENDED UP IN THE ILIAC ARTERY AND COULDN'T BE REMOVED. AN ATTEMPT HAD BEEN MADE TO SNARE THE STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6348636 ↗
• InjuryJan 31, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD A STENT PLACED PREVIOUSLY (2008) IN THE MID-PROX LAD. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND TORTUOUS DISTAL LAD LESION EXHIBITING 80% STENOSIS. NO DAMAGE NOTED TO DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT IN THE MID-PROX LAD ON A CURVE. RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT THE RESOLUTE INTEGRITY STENT GOT STUCK IN THE PREVIOUSLY DEPLOYED STENT. A BALLOON WAS USED IN AN ATTEMPT TO REMOVE THE DEVICE WITHOUT SUCCESS. THE PHYSICIAN PULLED BACK HARD AND THE DELIVERY SYSTEM CAME OUT WITHOUT THE STENT ON THE DELIVERY SYSTEM BALLOON. THE PHYSICIAN CRUSHED THE UN-DEPLOYED STENT IN TO THE LAD USING A NON-MDT STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6289056 ↗