Resolute Integrity™ RSINT22508UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037397), received between Apr 25, 2017 and Apr 8, 2019 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE COULD NOT CROSS THE LESION. FOLLOWING REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT STENT DISLODGEMENT HAD OCCURRED DURING DELIVERY TO THE LESION AND THAT THE STENT REMAINED AT THE TARGET LESION. THE STENT WAS CRUSHED AGAINST ARTERY WALL AT LOCATION IT DISLODGED. NO FURTHER INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 8490799 ↗
• DeathApr 25, 2017Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT (2.25X12) TO TREAT A MID CIRCUMFLEX VESSEL JUST AFTER AN ACUTE ANGLE OFF THE LEFT MAIN WITH SEVERE CALCIFICATION. THE DEVICE HAD BEEN REMOVED FROM PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A SPRINTER LEGEND BALLOON AND THE PHYSICIAN ATTEMPTED TO DELIVER THE RESOLUTE INTEGRITY STENT. IT WAS REPORTED THAT THE STENT WOULD NOT CROSS THE SEVERE 90 DEGREE BEND. THE STENT WAS REMOVED AND IT WAS NOTED THAT A FEW STENT STRUTS HAD LIFTED AND DEFORMED. THE LESION WAS PRE-DILATED AGAIN AND THE PHYSICIAN ATTEMPTED TO DELIVER ANOTHER RESOLUTE INTEGRITY STENT (2.25X8) BUT THE DEVICE ALSO FAILED TO CROSS. DURING REMOVAL OF THE SECOND RESOLUTE THE STENT DISLODGED AND WAS VISUALIZED IN THE ACUTE BEND OF THE CX. IT WAS REPORTED THAT SHORTLY AFTER, THE CX VESSEL HAD NO FLOW ( TIMI 0 ) AND CPR WAS PERFORMED. THE CX HAD COLLATERAL THAT SUPPLIED A TOTAL RCA. FLOW IN THE CX WAS NEVER RESUMED. THEN IN THE DISTAL LM AND PROXIMAL LAD THE PHYSICIAN OBSERVED A DISRUPTION OR DISSECTION WHICH WAS STENTED SUCCESSFULLY WITH A NON MDT STENT. THE PHYSICIAN FELT THE DISRUPTION MIGHT

  Patient problems: Death; Intimal Dissection; Occlusion; Patient Problem/Medical Problem

  MAUDE report 6517869 ↗