Resolute Integrity™ RSINT35018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037120), received between Jan 26, 2017 and May 6, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE DISLODGED STENT WAS VISIBLE IN THE PROXIMAL RCA. THE DISLODGED STENT WAS ATTEMPTED TO BE REMOVED MULTIPLE TIMES USING A SNARE AND AN ATTEMPT TO DEPLOY A NON-MEDTRONIC STENT ALSO FAILED. IT WAS STATED THAT A NON-MEDTRONIC STENT WAS FIRST DEPLOYED IN THE PROXIMAL LESION AND ADDITIONAL NON-MEDTRONIC STENTS WERE ATTEMPTED TO BE DELIVERED TO THE MID RCA LESION BUT FAILED AND WERE REMOVED SUCCESSFULLY. IT WAS STATED THAT ADDITIONAL DILATION WAS COMPLETED AND AN ATTEMPT TO DELIVER THE RESOLUTE INTEGRITY STENT FAILED. IT WAS STATED THAT AFTER THE 3RD FAILED DELIVERY OF THE RESOLUTE INTEGRITY STENT THE WIRE AND GUIDE WERE REMOVED. A NEW GUIDE AND WIRE WERE INS

  Patient problems: Injury

  MAUDE report 10027953 ↗
• MalfunctionMar 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A SEVERELY CALCIFIED MODERATELY TORTUOUS MID CX LESION. IT WAS REPORTED THAT THE PHYSICIAN USED 2 RESOLUTE INTEGRITY RX DRUG ELUTING STENTS. IN BOTH CASES, IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED REMOVING THE DEVICES FROM THE HOOP/TRAY. NO ISSUES NOTED DURING DEVICE INSPECTION. NEGATIVE PREP COMPLETED ON ONE OF THE DEVICES. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT THE PHYSICIAN USED EXCESSIVE FORCE AND DOTTERING TECHNIQUES IN ATTEMPTING TO DELIVER BOTH RESOLUTE STENTS, FRACTURING THE SHAFTS DURING DELIVERY. NEITHER DEVICE REACHED THE TARGET LESION. KINKS IN THE CATHETER WERE NOT STRAIGHTENED AND NO DETACHED PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE LESION AREA WAS SEVERELY CALCIFIED. A NON-MDT STENT WAS THEN SUCCESSFULLY DEPLOYED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6438392 ↗
• MalfunctionJan 26, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A HIGHLY CALCIFIED, LONG, TORTUOUS LCX LESION WITH 70% STENOSIS. DEVICE WAS INSPECTED BEFORE USE, NO ISSUES NOTED. LESION WAS PRE-DILATED WITH VARIOUS BALLOONS. RESISTANCE WAS NOTED ADVANCING TO THE LESION, EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WAS DAMAGED BY THE CALCIUM AND WAS NOT FIT FOR USE. FOUR STENTS WERE REPORTED TO BE DEPLOYED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6278610 ↗