Resolute Integrity™ RSINT35009UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037090), received between Feb 16, 2017 and Jan 30, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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.

• MalfunctionJan 30, 2019Difficult to Remove; Device Damaged by Another Device; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT WHILE ADVANCING THE STENT THROUGH SEVERE CALCIUM AND A NEWLY DEPLOYED STENT, THE RESOLUTE INTEGRITY ENCOUNTERED SEVERE RESISTANCE INSIDE THE STENT AND COULD NOT ADVANCE. THERE WERE TWO NON-MEDTRONIC GUIDE WIRES IN PLACE. THE DEVICE WAS PULLED BACK HOWEVER THE STENT BECAME CAUGHT INSIDE THE PREVIOUSLY DEPLOYED STENT AND POSSIBLY THE SECOND NON-MEDTRONIC GUIDE WIRE. THE RESOLUTE INTEGRITY STENT WAS PULLED BACK INTO THE GUIDE AND REMOVED WITH FORCE. IT WAS INDICATED THAT THE NON-MEDTRONIC GUIDE WIRE SEPARATED AND WRAPPED ON THE STENT BALLOON. IT WAS INDICATED THAT THE STENT UNRAVELED TO THE CORE WIRE. THE PATIENT IS REPORTED TO BE ALI VE WITHOUT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289089 ↗
• InjuryFeb 16, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO YOU A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND SEVERELY TORTUOUS MID LAD LESION EXHIBITING 90% STENOSIS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP TRAY. NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE PHYSICIAN PRE-DILATED THE LESION. DURING THE PROCEDURE, THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. IT IS REPORTED THAT THE RESOLUTE CAUGHT ON A STRUT AND DISLODGED WHEN THE PHYSICIAN PULLED BACK DEVICE. STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE PHYSICIAN CRUSHED THE STENT AGAINST THE DISTAL LAD WALL WITH ANOTHER STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6335114 ↗