Resolute Integrity™ RSINT30022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169037168), received between Dec 15, 2016 and Apr 11, 2019 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION SO IT WAS REMOVED FROM THE PATIENT. IT IS STATED THAT THE STENT FELT AS THOUGH IT WAS GETTING STUCK INSIDE THE GUIDE LINER. IT IS REPORTED THAT ON REMOVAL OF THE STENT IT WAS NOTED TO BE DEFORMED AT THE PROXIMAL END. THE PROCEDURE WAS COMPLETE USING THE SAME SIZE AND MODEL STENT. IT IS REPORTED THAT THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502827 ↗
• MalfunctionFeb 13, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8334439 ↗
• MalfunctionJan 17, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION IN THE OBTUSE MARGINAL (OM). THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. IT WAS REPORTED THAT THE STENT FRAYED WHILE ATTEMPTING TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8256250 ↗
• MalfunctionNov 30, 2018Use of Device Problem; Use of Device Problem

  A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A NON TORTUOUS, NON CALCIFIED LESION LOCATED IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT WAS IMPLANTED IN THE PATIENT 7 HOURS AFTER ITS EXPIRATION DATE. IT IS INDICATED THAT IT IS UNKNOWN HOW THE PRODUCT WAS ON THE SHELF FOR USE AS PRODUCT NEAR EXPIRY DATE IS PULLED AND PUT IN THE INVENTORY OFFICE TO BE CHECKED OUT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8118993 ↗
• MalfunctionApr 23, 2018Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE STENT HAD DIFFICULTY ADVANCING THROUGH A PREVIOUSLY DEPLOYED STENT TO THE LESION SITE. THE PHYSICIAN THEN REMOVED THE STENT AND NOTED THAT THE STRUTS HAD FLARED DURING ADVANCEMENT. A RSINT30018UX DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450042 ↗
• MalfunctionSep 18, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT (3.0X22MM) TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 70% STENOSIS IN THE MID LAD. THE LESION WAS PRE-DILATED. 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. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WAS DAMAGED BY THE CALCIUM; ON REMOVAL THE PHYSICIAN EXAMINED THE STENT AND IT WAS REPORTED TO BE BENT. THE PHYSICIAN FELT THAT THE TIP WAS SLIGHTLY BENT FROM THE CALCIFICATION. NO ADDITIONAL DEVICES WERE REQUIRED TO REMOVE THE STENT. THE PROCEDURE WAS THEN COMPLETED USING A GUIDELINER AND A LONGER STENT, RESOLUTE INTEGRITY 3.0X38MM. THERE IS NO PATIENT INJURY. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6872152 ↗
• MalfunctionApr 18, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO TREAT A SEVERELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LAD LESION EXHIBITING 95% STENOSIS USING A RESOLUTE INTEGRITY DRUG ELUTING STENT. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE INSPECTED AND NEGATIVE PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE STENT WAS SUCCESSFULLY DEPLOYED AND BALLOON DEFLATED WITH NO ISSUES NOTED, BUT AS THE BALLOON CATHETER WAS WITHDRAWN IT SEEMED TO "CATCH" ON THE DISTAL END OF THE CATHETER. IT WAS REPORTED THAT WITH SOME PERSISTENCE THE BALLOON CATHETER WAS ABLE TO BE PULLED INTO THE CATHETER, BUT THE WIRE CAME WITH IT, ALTHOUGH THE CATHETER REMAINED IN THE AORTA. THE SAME WIRE WAS USED TO REQUIRE THE VESSEL AND A SECOND RESOLUTE WAS DEPLOYED DISTAL TO THE FIRST ONE WITH NO ISSUES NOTED ON EITHER DEPLOYMENT OR REMOVAL OF THE SECOND BALLOON CATHETER. ON REMOVAL OF THE BALLOON FROM THE STENT NO RESISTANCE ENCOUNTERED AS THE DEVICE WAS RETRACTED OVER THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499437 ↗
• MalfunctionFeb 28, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A CALCIFIED MID - DISTAL RCA LESION. PRE-DILATION WAS CARRIED OUT USING A EUPHORA BALLOON. THE STENT WAS ADVANCED BUT FAILED TO CROSS THE TARGET LESION. IT WAS REPORTED THAT WHEN REMOVED IT WAS NOTED THAT THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED USING RESOLUTE STENTS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6363775 ↗
• DeathDec 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS SENT HOME ON MAXIMUM MEDICAL THERAPY AS SURGERY WAS NOT AN OPTION. THE ANGINA PERSISTED AND THE PATIENT RETURNED TO THE ER 3 DAYS LATER WITH UNRELENTING CHEST PAIN. DIAGNOSTIC CATHETER SHOWED A SEVERELY CALCIFIED NON-TORTUOUS OSTIUM CX LESION. IVUS SHOWED SIGNIFICANT PLAQUE BURDEN. THE LEFT MAIN WAS PRE-DILATED WITH AN NC EUPHORA BALLOON WITH NO ISSUES NOTED. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 3.0MMX22MM RESOLUTE INTEGRITY STENT FROM THE LM TO THE CIRCUMFLEX..THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT WHEN THEY DEPLOYED THE RESOLUTE INTEGRITY STENT THE PATIENT HAD A SPIRAL DISSECTION IN THE CIRCUMFLEX AND STARTED TO LOSE CIRCULATION. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE CALCIFIED AREA OF THE VESSEL WAS AFFECTED BY THE STENT PLACEMENT. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE 2 X RESOLUTE INTEGRITY 2.50MMX18MM STENTS IN THE CIRCUMFLEX TO SALVAGE THE ARTERY. BOTH STENTS PASSED THROUGH PREVIOUSLY DEPLOYED STENTS. NO RESISTANCE OR EXCESSIVE FORCE WAS USE

  Patient problems: Death; Intimal Dissection

  MAUDE report 6176782 ↗