Resolute Integrity™ RSINT35012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037106), received between Mar 28, 2017 and Apr 18, 2018 — 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.

• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED WITHOUT ANY REPORTED ISSUES. IT IS REPORTED THAT POST IMPLANT THAT THE PATIENT HAS BLOOD ON THE BRAIN. IT IS NOT KNOWN IF THIS ISSUE IS IN ANY WAY RELATED TO THIS PATIENT'S STENT. PATIENT IS TO HAVE AN MRI.

  Patient problems: Stroke/CVA

  MAUDE report 7439153 ↗
• MalfunctionApr 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE OSTIUM OF THE RIGHT CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE PHYSICIAN WENT TO INFLATE THE STENT AND THEN DEFLATED THE BALLOON AND NOTICED THAT THERE WAS NO STENT. THE LESION WAS AT AN ANGLE AND THE PHYSICIAN HAD TO BRING THE STENT BACK INTO THE GUIDE SEVERAL TIMES DUE TO LACK OF SUPPORT, IT IS REPORTED THAT THIS MAY BE WHY THE STENT DISLODGED. NO INTERVENTION WAS CARRIED OUT. THE PHYSICIAN SCANNED THE PATIENT FROM TRUNK TO HEAD BUT THE STENT COULD NOT BE FOUND. THE PATIENT IS ALIVE WITHOUT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421492 ↗
• 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 . IT 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 6438388 ↗