Resolute Integrity™ RSINT35026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169037144), received between Mar 24, 2017 and Aug 9, 2018 — classified as 3 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 18, 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.

• MalfunctionAug 9, 2018Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7766414 ↗
• MalfunctionSep 22, 2017Device Expiration Issue; Device Expiration Issue

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION IN THE RCA. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING DEVICE FROM HOOP/TRAY. DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT WAS IMPLANTED APPROXIMATELY 16 DAYS POST EXPIRY DATE. NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REPORTED. THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885689 ↗
• MalfunctionMar 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS TREATING THE MID LAD- DIAGONAL BRANCH. THE VESSEL HAD SEVERE CALCIFICATION, 90% STENOSIS AND SEVERE TORTUOSITY; ARTERY DIAMETER 3.5MM. THE PHYSICIAN IMPLANTED ONE RESOLUTE INTEGRITY 3.0 X 26MM DRUG-ELUTING STENT IN THE 3RD DIAGONAL VESSEL INTO THE LAD AT THE BIFURCATION. MULTIPLE BALLOONS WERE PASSED THROUGH THE STENT STRUTS TO PTA THE MID LAD. THEN MULTIPLE STENTS WERE ATTEMPTED TO BE PLACED IN THE LAD WHICH RESULTED IN 5 NO CROSSES. ONE OF THE DEVICES THAT DID NOT CROSS WAS A SECOND 3.5X26MM RESOLUTE INTEGRITY. DURING DELIVERY OF THE SECOND 3.5X26MM RESOLUTE INTEGRITY, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THE SHAFT BROKE. EXCESSIVE FORCE WAS USED DURING DELIVERY AND THE DEVICE DID PASS THROUGH THE PREVIOUSLY DEPLOYED STENT. THE SHAFT OF THE DEVICE SNAPPED IN HALF BUT WAS REMOVED FROM THE PATIENT USING NORMAL PROCEEDINGS. THEN A 3.5X20MM CHOCOLATE BALLOON CATHETER WAS PASSED THROUGH THE STENTS STRUTS TO PTA THE MID LAD. UPON REMOVAL OF THE CHOCOLATE BALLOON, ONE OF THE NITINOL WIRES THAT MAKE UP THE CAGE WAS CAUGHT IN THE FIRST 3.0 X 26MM STENT. IT WAS REPORTED THAT THIS CAUSED THE STENT TO FRACTURE, AND 2/3 OF THE STENT BECAME DISLODGED AND W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6430880 ↗