Resolute Integrity™ RSINT30030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037182), received between Apr 18, 2017 and May 8, 2018 — classified as 3 malfunctions.

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

• MalfunctionMay 8, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION LOCATED IN A MILDLY TORTUOUS RIGHT CORONARY ARTERY. 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 PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE DEVICE WAS REMOVED THROUGH THE GUIDE CATHETER. ANOTHER RESOLUTE INTEGRITY OF THE SAME SIZE AND LOT WAS THEN USED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493477 ↗
• MalfunctionApr 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY, EXHIBITING 90% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED 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 NOT 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 THE STENT DEFORMATION OCCURRED DURING POSITIONING/ADVANCEMENT. IT WAS REPORTED THAT THE STENT CAUGHT ON THE GUIDELINER DURING ADVANCEMENT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY. THE PROCEDURE WAS COMPLETED WITH A STENT OF THE SAME SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395028 ↗
• MalfunctionApr 18, 2017Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  THE PHYSICIAN INTENDED TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS REPORTED TO BE MODERATELY TORTUOUS AND SEVERELY CALCIFIED. IT WAS REPORTED THAT ORBITAL ATHERECTOMY WAS USED PRIOR TO STENT DEPLOYMENT DUE TO THE HEAVY CALCIFICATION OF THE LESION. NO DAMAGE WAS NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PREFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DURING BALLOON INFLATION, DIFFICULTIES WERE NOTED WHEN THE BALLOON WAS INFLATED TO 9 ATM. THE BALLOON ONLY PARTIALLY INFLATED. IT IS REPORTED THAT THE WHEN THE CATHETER WAS REMOVED, THE PHYSICIAN FOUND THAT THE SHAFT HAD A POSSIBLE HOLE IN IT. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. STENT WAS NOT IMPLANTED. THE SAME INFLATION DEVICE WAS NOT USED WITH OTHER DEVICES PRE/POST THE INFLATION DIFFICULTIES. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499486 ↗