Resolute Integrity™ RSINT35038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037298), received between Jan 10, 2018 and Feb 5, 2018 — 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 18, 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.

• MalfunctionFeb 5, 2018Material Deformation; Material Deformation

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A PATIENT. NO ISSUES WERE ENCOUNTERED WHEN PREPPING AND PREPARING THE DEVICE. THE LESION WAS PRE-DILATED. IT IS REPORTED THAT A RESOLUTE INTEGRITY STENT FAILED TO CROSS A LESION. UPON REMOVAL OF THE DEVICE FROM THE PATIENT, THE STENT WAS NOTED TO HAVE DAMAGED STRUTS. NO PATIENT INJURY, ISSUE OR COMPLICATION IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7240748 ↗
• MalfunctionJan 10, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION LOCATED AT THE RIGHT CORONARY ARTERY. THERE WERE THERE 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. NO DIFFICULTIES WERE NOTED DURING THE REMOVAL OF THE PROTECTIVE SHEATH AND DURING THE REMOVAL OF THE PACKAGING STYLETTE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THERE WAS A KINK AT THE TIP OF THE CATHETER/DELIVERY SYSTEM. THE TIP DAMAGE WAS FIRST NOTED WHEN THE PHYSICIAN WENT TO DELIVER THE STENT AND LOADED IT ONTO THE GUIDE WIRE; THE DEVICE WAS INSERTED INTO THE PATIENT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY. DEFORMATION OF STENT WAS NOTED DURING ANALYSIS. DEVICE ANALYSIS SHOWED THAT THE DISTAL END OF THE STENT WAS DAMAGED AND THE ACCOUNT HAS CONFIRMED THAT WAS INITIALLY REFERRED TO AS THE TIP OF THE C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7178295 ↗