Resolute Integrity™ RSINT30026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169037175), received between Jan 11, 2017 and Jul 25, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2018Inadequacy of Device Shape and/or Size; Malposition of Device; Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE PATIENT PRESENTED WITH STEMI AND THROMBUS. A 3.00X26 MM RESOLUTE INTEGRITY DEVICE WAS USED TO TREAT A MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE OSTIUM OF THE LEFT MAIN TO THE PROXIMAL LAD (ARTERY DIAMETER 4.00 MM, LESION LENGTH 26 MM). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THE PATIENT WAS PUT ON DAPT. IT IS REPORTED THAT APPROXIMATELY ONE HOUR AFTER THE RESOLUTE INTEGRITY DEVICE WAS IMPLANTED, THE PATIENT HAD ST EVENT ELEVATIONS, SO THE PATIENT WAS BROUGHT BACK TO THE CATH LAB WHERE THE STENTED VESSEL WAS 100% OCCLUDED AT THE STENT SITE. THERE WAS ST ELEVATION POST STENTING DUE TO AN EXIT DISSECTION AND AN UNDERSIZED, MALAPPOSED STENT (THE STENT WAS TOO SMALL FOR THE VESSEL). IT WAS REPORTED THAT THE STENT WAS TOO SMALL FOR THE VESSEL AND UNDER EXPANDED. THE PHYSICIAN NOTED THROMBOTIC APICAL OCCLUSION AND WENT BACK IN WITH SEVERAL BALLOONS INCLUDING NON-CO

  Patient problems: Occlusion; ST Segment Elevation; Thrombus; Vascular Dissection

  MAUDE report 7718412 ↗
• MalfunctionSep 28, 2017Material Deformation; Material Deformation

  THE PATIENT PRESENTED TO THE EMERGENCY WITH CHEST PAIN AND PRE-OPERATIVE DIAGNOSIS OF NSTMI WITH POSITIVE TROPONIN BUT NO EKG CHANGES. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS MID CX LESION EXHIBITING 90-99% STENOSIS. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING DEVICE FROM HOOP/TRAY. DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS CROSSED WITH A 0.014 INCH GUIDEWIRE AND PRE-DILATED AT 14 ATM . THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY BUT NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE TARGET LESION AND STENT DEFORMATION IN VIVO DURING POSITIONING OCCURRED . THE LESION WAS AGAIN PRE-DILATED UP TO 12ATM AT MULTIPLE SITES. THE PROCEDURE WAS COMPLETED WITH FURTHER STENTING WITH RESOLUTE INTEGRITY STENTS. THERE WERE NO FURTHER EVENTS WITH THE STENTS THAT WERE USED TO COMPLETE THE PROCEDURE. THERE ARE NO INJURIES REPORTED. THE PATIENT'S MEDICATIONS ON DISCHARGE INCLUDED PLAVIX, ASPIRIN AND A STATIN AND A LOW DOSE BETA BLOCKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901036 ↗
• MalfunctionAug 2, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. IT IS REPORTED THAT THE DEVICE WAS UNABLE TO CROSS IN THE MID RCA AND THE STENT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759567 ↗
• MalfunctionMar 24, 2017Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  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 6430895 ↗
• MalfunctionFeb 14, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, 90% STENOSIS AND TORTUOUS LAD LESION. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. SOME RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE STENT, IT WAS REMOVED TO FURTHER DILATE THE LESION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WAS DAMAGED DUE TO THE VESSEL TORTUOSITY. THE PHYSICIAN CROSSED WITH ANOTHER RESOLUTE INTEGRITY STENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6328342 ↗
• MalfunctionJan 11, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN THE CIRCUMFLEX ARTERY . LESION EXHIBITED 90% STENOSIS, MINIMAL TORTUOSITY AND WAS HIGHLY CALCIFIED . NO ANATOMICAL ABNORMALITIES WERE REPORTED. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED POST-REMOVAL FROM PACKAGING WITH NO ISSUES NOTED. RESISTANCE WAS NOTED IN ADVANCING THE DEVICE AND EXCESSIVE FORCE IS REPORTED TO HAVE BEEN USED .THE PHYSICIAN TRIED TO CROSS, BUT THE LESION WAS VERY CALCIFIED. THE STENT STRUT IS REPORTED TO HAVE BEEN BENT (DEFORMED) AS A RESULT OF ATTEMPTING TO CROSS THE LESION. THE DEFORMATION WAS NOTED WHEN THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER RESOLUTE INTEGRITY RX DRUG ELUTING STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6240218 ↗