Resolute Integrity™ RSINT22522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169037434), received between Dec 5, 2016 and Jan 17, 2020 — classified as 1 death, 2 injuries, 3 malfunctions.

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

• DeathJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS WERE USED TO TREAT CHEST PAIN. THE PATIENT LATER PASSED AWAY IN HOSPITAL.

  Patient problems: Death

  MAUDE report 9601987 ↗
• MalfunctionMay 24, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL (OM). IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS THE LESION DUE TO STENT DEFORMATION. IT WAS DESCRIBED THAT A WIRE BARB WAS ON THE STENT. THE PROCEDURE WAS THEN COMPLETED USING A RESOLUTE INTEGRITY OTW DEVICE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7539815 ↗
• InjuryMay 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION, WITH 90% STENOSIS, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. 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 DEVICE FAILED TO CROSS THE TARGET LESION. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE AND THE STENT DISLODGED IN THE RIGHT RADIAL SIDE OF THE WRIST. A SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE STENT AND THE PROCEDURE WAS COMPLETED USING A RESOLUTE CORONARY DRUG ELUTING STENT 225MM X 12MM. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: Embolism

  MAUDE report 7479116 ↗
• InjurySep 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY STENT TO TREAT A LESION. NO STENT ON FLUORO, NO STENT FOUND IN BODY, BED OR FLOOR.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6878629 ↗
• MalfunctionFeb 6, 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 MODERATELY CALCIFIED AND TORTUOUS MID CX LESION. NO DAMAGE NOTED TO PACKAGING, AND NO ISSUES NOTED DURING REMOVAL. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DURING REMOVAL FOLLOWING FAILED DELIVERY, IT WAS REPORTED THAT THE DEVICE GOT STUCK IN THE GUIDE AND THE STENT DISLODGED IN THE GUIDE. THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6303163 ↗
• MalfunctionDec 5, 2016Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A SLIGHTLY TORTUOUS AND SEVERELY CALCIFIED MID LAD LESION EXHIBITING 85% STENOSIS. NO DAMAGE NOTED TO DEVICE PACKAGING OR ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED 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 DURING DELIVERY AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT AFTER TRYING TO UNSUCCESSFULLY DELIVER THE STENT TO THE LESION, THE STENT WAS REMOVED. UPON INSPECTION IT WAS NOTED THAT THE STENT MAY HAVE BECOME DISLODGED FROM THE BALLOON. THE PHYSICIAN COMMENTED THAT THE STENT WAS OBSERVED TO BY ROUGHED UP ON THE END AND NOT CENTERED ON THE BALLOON AFTER REMOVAL DUE TO NO CROSS. ANOTHER RESOLUTE WAS USED TO PROGRESS THE CASE. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6144245 ↗