Resolute Integrity™ RSINT30015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169037502), received between Dec 15, 2016 and Sep 7, 2021 — classified as 3 deaths, 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS INTENDED TO USE A RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE MID LAD. IT WAS REPORTED THAT THE STENT CAME OFF FROM THE BALLOON INSIDE A NON-MDT GUIDE EXTENSION CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432948 ↗
• DeathFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED ((B)(6) 2013) WITHOUT ANY REPORTED ISSUE. IT WAS REPORTED THAT THE PATIENT EXPIRED APPROXIMATELY 6 YEARS LATER ((B)(6) 2019).

  Patient problems: Death

  MAUDE report 8309981 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT FAILED TO CROSS INTO A SVG GRAFT AND WAS THEN DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925275 ↗
• InjuryMay 8, 2018Material 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 AND MILDLY TORTUOUS LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A RIGHT RADIAL APPROACH WAS USED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING THE DELIVERY OF THE STENT TO THE MID LAD, THE DELIVERY CATHETER BROKE JUST DISTAL TO THE LUER/HUB. THE STENT WAS NOT DEPLOYED, AND THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. AN ATTEMPT WAS MADE TO USE ANOTHER RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT THE SAME LESION. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION PRE-DILATE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7493637 ↗
• MalfunctionMar 8, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION. THE TARGET LESION WAS HEAVILY CALCIFIED WITH 90% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING DEVICE FROM HOOP. THE DEVICE WAS INSPECTED PRIOR TO USE. NEGATIVE PREP WAS PERFORMED PRIOR TO USE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DURING AN ATTEMPT TO TREAT THE LESION IN THE LCX USING THE RESOLUTE INTEGRITY DRUG ELUTING STENT, THE LEFT CIRCUMFLEX WAS WIRED TO ITS DISTAL EXTENT USING A 0.014 NON-MEDTRONIC WIRE. THIS WAS USED TO DELIVER A 3.0 X 15 SPRINTER BALLOON TO THE MID CIRCUMFLEX STENOSIS WHERE A SERIES OF INFLATIONS WERE PERFORMED TO 10 ATM OF PRESSURE IN ORDER TO RELEASE THE LESION AND PREPARE IT FOR CORONARY STENTING. AN ATTEMPT WAS THEN MADE TO DELIVER A 3.0 X 15 RESOLUTE DES TO THE LESION SITE, HOWEVER THE STENT WOULD NOT CROSS THE TORTUOUS PROXIMAL CIRCUMFLEX WHICH WAS HEAVILY CALCIFIED, IMPEDING STENT PASSAGE. ACCORDINGLY, THE STENT WAS REMOVED FROM THE BODY AND INSTEAD A 3.0 X 8 NON-MEDTRONIC DEVICE WAS ADVANCED TO THE LESION SITE AND DEPLOYED AT 14 ATM OF PRESSURE. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323380 ↗
• DeathNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN IMPLANTED 3 RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS IN THE PROXIMAL, MID LAD WHICH HAD SEVERE TORTUOSITY AND CALCIFICATION WITH 100% STENOSIS (CTO). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE LESION. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE MID LAD AND POST-DILATED WITH A NC EUPHORA (3.25X8). ANOTHER RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE PROX LAD AND POST-DILATED WITH THE SAME NC EUPHORA BALLOON. A RESOLUTE INTEGRITY DES (2.75X30) WAS IMPLANTED IN THE MID RCA AND WAS POST-DILATED BY THE SAME NC EUPHORA BALLOON. IT WAS REPORTED THAT 7 DAYS POST MDT STENT IMPLANTATION, THE PATIENT CAME INTO THE ER WITH A STEMI AND VT (VENTRICULAR TACHYCARDIA). THE PATIENT RECEIVED DEFIBRILLATION TWICE, A CVL (CENTRAL VENOUS LINE), CPR WITH BALLOON PUMP AND LHC (LEFT HEART C

  Patient problems: Death; Myocardial Infarction; Thrombus

  MAUDE report 7052411 ↗
• DeathNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN IMPLANTED 3 RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENTS IN THE PROXIMAL, MID LAD WHICH HAD SEVERE TORTUOSITY AND CALCIFICATION WITH 100% STENOSIS (CTO). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE LESION. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE MID LAD AND POST-DILATED WITH A NC EUPHORA (3.25X8). ANOTHER RESOLUTE INTEGRITY DES (3.0X15) WAS IMPLANTED IN THE PROX LAD AND POST-DILATED WITH THE SAME NC EUPHORA BALLOON. A RESOLUTE INTEGRITY DES (2.75X30) WAS IMPLANTED IN THE MID RCA AND WAS POST-DILATED BY THE SAME NC EUPHORA BALLOON. IT WAS REPORTED THAT 7 DAYS POST MDT STENT IMPLANTATION, THE PATIENT CAME INTO THE ER WITH A STEMI AND VT (VENTRICULAR TACHYCARDIA). THE PATIENT RECEIVED DEFIBRILLATION TWICE, A CVL (CENTRAL VENOUS LINE), CPR WITH BALLOON PUMP AND LHC (LEFT HEART C

  Patient problems: Death; Myocardial Infarction; Thrombus

  MAUDE report 7052401 ↗
• MalfunctionOct 6, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WHICH WAS REPORTED TO BE MODERATELY TORTUOUS, MODERATELY CALCIFIED WITH 90% STENOSIS (IN STENT RE-STENOSIS OF AN OVERLAPPING NON MEDTRONIC STENT). NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES FOUND. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED USING A NON MEDTRONIC BALLOON. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT WAS PUSHED ACROSS THE LESION WITH RESISTANCE. WHEN IT WOULD NOT CROSS, THE STENT WAS REMOVED FROM THE PATIENT AND UPON INSPECTION IT WAS IDENTIFIED THAT A STENT STRUT HAD LIFTED UP TO A 90-DEGREE ANGLE. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE INTEGRITY WHICH WAS DEPLOYED SUCCESSFULLY AND CROSSED THE OVERLAPPING STENT. THERE IS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6921402 ↗
• MalfunctionAug 21, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG-ELUTING STENT TO TREAT A LESION IN THE RCA. IT IS REPORTED THAT WHEN THE STENT WAS REMOVED, THE STENT STRUT WAS SEEN TO BE JUTTING OUT. ANOTHER RESOLUTE INTEGRITY STENT WAS USED. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6806965 ↗
• MalfunctionMay 18, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES FOUND. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING/ADVANCEMENT . WHEN THE DEVICE WAS REMOVED, A FLARE WAS OBSERVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. A NEW RESOLUTE STENT WAS PLACED TO REPLACE THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574636 ↗
• InjuryJan 11, 2017Inaccurate Delivery; Device Dislodged or Dislocated; Inaccurate Delivery; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND SLIGHTLY TORTUOUS MID RCA LESION EXHIBITING 95% STENOSIS. IT WAS REPORTED THAT NO ISSUES WERE NOTED TO THE DEVICE PACKAGING OR ISSUES ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE HOOP / TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH, THE STENT WAS INSPECTED POST REMOVAL OF SHEATH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE STENT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT WHILE MANEUVERING THE STENT THROUGH THE PREVIOUSLY DEPLOYED STENT , THE STENT DISLODGED IN THE PROXIMAL RCA. IT WAS REPORTED THAT THE PHYSICIAN PASSED THE BALLOON BACK THROUGH THE STENT AND DEPLOYED THE STENT IN THE PROXIMAL RCA. THE PROXIMAL RCA WAS THEN RESTENTED SUCCESSFULLY WITH ANOTHER 3.0X15MM RESOLUTE INTEGRITY STENT. THE PHYSICIAN THEN USED A GUIDELINER THROUGH BOTH PROXIMAL STENTS AND DELIVERED

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6240278 ↗
• MalfunctionDec 15, 2016Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE TWO RESOLUTE INTEGRITY 3.0 X 15MM DRUG-ELUTING STENTS. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS CONFIRMED THAT THE STENTS WERE COMPLETELY INTACT WITH NO ISSUES NOTED WHEN REMOVED FROM THE SHEATH. NEGATIVE PREP WAS PERFORMED ON THE DEVICES. THE STENTS WERE REPORTED TO BE DEFORMED WHEN IN THE BODY BEING PUSHED UP AGAINST HEAVILY CALCIUM IN A CTO VESSEL, FOLLOWING MANY PRE-DILATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176520 ↗
• MalfunctionDec 15, 2016Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE TWO RESOLUTE INTEGRITY 3.0 X 15MM DRUG-ELUTING STENTS. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WAS NO DAMAGE NOTED TO THE PACKAGING, I.E. SHELF CARTON, HOOP/ TRAY. IT WAS CONFIRMED THAT THE STENTS WERE COMPLETELY IN TACT WITH NO ISSUES NOTED WHEN REMOVED FROM THE SHEATH. NEGATIVE PREP WAS PERFORMED ON THE DEVICES. THE STENTS WERE REPORTED TO BE DEFORMED WHEN IN THE BODY BEING PUSHED UP AGAINST HEAVILY CALCIUM IN A CTO VESSEL, FOLLOWING MANY PRE-DILATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176517 ↗