Resolute Integrity™ RSINT25022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169037380), received between Jan 9, 2017 and Jan 17, 2020 — classified as 1 death, 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 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 9601895 ↗
• InjuryMay 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION, LOCATED IN THE PROXIMAL DIAGONAL BRANCH ARTERY, EXHIBITING 80% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS REPORTED THAT A MEDTRONIC BALLOON WAS USED TO DEPLOY THE STENT IN THE DIAGONAL BRANCH. ANOTHER MEDTRONIC BALLOON WAS USED TO DILATE THE PORTION OF THE STENT THAT WAS IN THE LAD. PATIENT IS REPORTED TO BE DOING WELL POST PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7539807 ↗
• MalfunctionDec 14, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. 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. NEGATIVE PREP WAS NOT PERFORMED. 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 IS REPORTED THAT THE DEVICE WAS HUNG UP INSIDE A NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE ISSUE OCCURRED DURING ADVANCEMENT OF THE DEVICE AND DURING WITHDRAWAL OF THE DEVICE FROM THE GUIDE CATHETER. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. NO ISSUES NOTED WITH THE NON-MDT GUIDE CATHETER PRIOR TO THE STENT BEING HUNG UP. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116352 ↗
• MalfunctionNov 6, 2017Material Deformation; Material Deformation

  THE PHYSICIAN USED A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RAMUS ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES AND NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT IS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING CORONARY BALLOONS ACROSS THE LESION. THE RESOLUTE INTEGRITY DEVICE ENCOUNTERED EXTREME RESISTANCE AND WAS UNABLE TO CROSS THE LESION DUE TO THE EXCESSIVE CALCIFICATION IN THE RAMUS. UPON REMOVAL FROM THE BODY THE STENT WAS EXAMINED AND WAS NOTED TO BE DEFORMED ON THE PROXIMAL STRUTS; STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A 2.5X18MM RESOLUTE INTEGRITY RX DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7002553 ↗
• InjurySep 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN AN UNKNOWN VESSEL. AB NORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE. DURING DELIVERY, RESISTANCE WAS EN COUNTERED AND EXCESSIVE FORCE WAS USED. WHILE ATTEMPTING TO PLACE THE STENT, THE SHAFT OF THE CATHETER BROKE IN HALF. THE DEVICE WAS KINKED AND RESTRAIGHTENED DURING USE. THE BROKEN HALF OF THE DEVICE WAS RETRIEVED WITH SNARE. THE PHYSICIAN TOOK COMPLETE RESPONSIBILITY FOR THE SHAFT BREAKING. THE PHYSICIAN REPEATEDLY PUSHED AND PULLED VERY HARD AND ROUGH ON THE CATHETER WHILE ATTEMPTING TO DELIVER THE DEVICE. THE PHYSICIAN REPORTED THAT IT WAS A VERY DIFFICULT CASE, AND NOT A PRODUCT FAILURE. THE STENT WAS IMPLANTED. PATIENT HEALTH STATUS POST PROCEDURE IS ALIVE, FINE, AND NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6903283 ↗
• MalfunctionSep 6, 2017Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION IN THE LAD. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. IT IS REPORTED THAT THE STENT WOULD NOT ENTER THE GUIDELINER AND IT CRUMPLED UP ON ITSELF WHILE TRYING TO GO THROUGH THE GUIDELINER . STENT DISPLACEMENT OCCURRED WHILE IN THE PATIENT AND THE STENT REMAINED ON THE DELIVERY SYSTEM WHEN REMOVAL FROM THE BODY. THE SURGICAL TEAM TOOK THE STENT OFF THE DEVICE TO INSPECT IT ONCE IT WAS REMOVED FROM THE BODY. IT WAS REPORTED THAT THIS WAS A VERY DIFFICULT CASE AND THE PATIENT HAD BEEN DENIED SURGERY. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE INTEGRITY DEVICE. PATIENT IS OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6844940 ↗
• MalfunctionAug 22, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LAD LESION WITH (B)(4) STENOSIS. THERE ARE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE WAS NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. PRIOR TO USE AND DURING INSPECTION / PREP, NO ISSUES WERE NOTED WITH THE DEVICE WHEN THE PACKAGING STYLET AND PROTECTIVE PLASTIC SHEATH WERE REMOVED. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 USED DURING DELIVERY. THE PHYSICIAN NOTED DIFFICULTY ADVANCING THE STENT THROUGH THE CALCIFIED LESION. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. AFTER THE CATHETER WAS REMOVED, THE STENT WAS SEEN TO BE DEFORMED AND IT WAS REPORTED TO HAVE SLIPPED OFF THE BALLOON CATHETER AFTER REMOVAL FROM THE PATIENT. A NON MDT STENT WAS THEN USED, AND THE SAME ISSUE OCCURRED W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6809453 ↗
• InjuryAug 8, 2017Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION IN THE PROXIMAL CX ARTERY WITH 80% STENOSIS. IT IS REPORTED THAT THE PATIENT HAS A CALCIFIED CARINA BUT SEVERITY IS NOT LISTED. THE LESION WAS PRE-DILATED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO DIFFICULTIES WITH REMOVING THE STYLETTE OR PROTECTIVE SHEATH. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. INFLATION DEVICE WAS NEUTRAL.  TO REMOVE THE DISLODGED STENT, IT WAS SNARED FROM THE PROFUNDA FEDERAL ARTERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6773051 ↗
• InjuryJan 25, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT A MILDLY CALCIFIED AND NON -TORTUOUS MID RCA LESION. NO ISSUES WERE NOTED WITH THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP/ TRAY AND INSPECTED WITH NO ISSUES NOTED. RIGHT RADIAL APPROACH WAS USED DURING THE PROCEDURE. PROX RCA WAS PRE-DILATED 4 TIMES TO A MAX OF 13 ATMS WITH A BALLOON. 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 STENT WAS PREPPED AFTER CROSSING THE LESION AND INFLATED TO 13ATM. THE PHYSICIAN COULD NOT VISUALIZE STENT DEPLOYMENT UNDER FLORO. IT WAS AS IF THE BALLOON HAD BEEN INFLATED WITH AIR. IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND RESIDUAL AIR REMAINED. IT WAS REPORTED THAT IT FELT AS IF THERE WAS AN ISSUE WITH THE INFLATION LUMEN. NO CONTRAST COULD BE SEEN IN THE BALLOON. THE STENT WAS UNDER-DEPLOYED. DIFFICULTY WAS ENCOUNTERED RECROSSING WITH ANOTHER BALLOON. IT WAS THAT THE PHYSICIAN ENDED UP GETTING THE STENT FURTHER EXPANDED IN THE RCA USING VERY SMALL BALLOONS. ANOTHER STENT WAS PLACED AFTE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6275507 ↗
• InjuryJan 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL CIRCUMFLEX. THE LESION IS REPORTED TO HAVE MODERATE TORTUOSITY, SEVERE CALCIFICATION AND 90% STENOSIS. NO ANATOMICAL ABNORMALITIES WERE REPORTED. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH ANY PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER NO EXCESSIVE FORCE WAS USED. THE RESOLUTE STENT WAS UNABLE TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED FOLLOWING FAILED DELIVERY. THE STENT WAS SUCCESSFULLY REMOVED USING A SNARE. THE STENT DISLODGEMENT WAS ATTRIBUTED TO THE PRESENCE OF SIGNIFICANT CALCIUM. SURGERY WAS COMPLETED SUCCESSFULLY. NO INJURY IS REPORTED TO HAVE OCCURRED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6232237 ↗