Resolute Integrity™ RSINT27526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037465), received between Jun 16, 2017 and Dec 5, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION IN THE MID LAD WITH 95% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS WAS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING. IT WAS NOTED THAT A DISTAL STENT STRUT STUCK OUT WHILE STILL ON THE BALLOON. THE PHYSICIAN COMPLETED THE PROCEDURE AND THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7081967 ↗
• MalfunctionJun 16, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TARGET LESION WAS REPORTED TO BE MODERATELY TORTUOUS, SEVERELY CALCIFIED WITH 90% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE TRAY/HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES. THE DEVICE WAS NOT KINKED OR RESTRAIGHTENED DURING USE. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO CROSS THE LESION. UPON REMOVAL OF THE STENT THE DOCTOR SAID HE FELT SOME RESISTANCE. THE PHYSICIAN COULD NOT TELL IF THE TIP WAS FRACTURED, HE INSPECTED CLOSELY. IT WAS OBSERVED WHEN THE STENT WAS OUTSIDE THE GUIDE THAT IT HAD UNRAVELED. IT STAYED ON THE BALLOON AND DID NOT DISLODGE THROUGH THE SYSTEM. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645985 ↗