Resolute Integrity™ RSINT22512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169037403), received between Jan 24, 2017 and Jan 24, 2018 — classified as 1 death, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 24, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS INTENDING ON IMPLANTING A RESOLUTE INTEGRITY DRUG ELUTING STENT INTO A PATIENT. NO DAMAGE WAS NOTED TO THE PACKAGING NOR WERE THERE ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE PROTECTIVE SHEATH WAS PRESENT ON THE STENT AFTER IT WAS REMOVED FROM THE HOOP AND THERE WERE NO DIFFICULTIES REMOVING THE SHEATH. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT SLIPPED WHILE LOADING THROUGH THE HAEMOSTATIC VALVE. THE STENT CAME OFF THE BALLOON DISTAL TO THE HAEMOSTATIC VALVE. THE ACCOUNT NOTED THAT THE STENT WAS HARD TO TRACK THROUGH THE GUIDE CATHETER SO THE PHYSICIAN PULLED BACK THE DELIVERY SYSTEM AND OBSERVED THAT STENT SLIPPAGE HAD OCCURRED IN THE GUIDE. THE PHYSICIAN CHANGED OUT THE GUIDE CATHETER AND REWIRED THE VESSEL AND PUT IN NEW STENT. THE DEVICE WAS REPLACED WITH A MEDTRONIC PRODUCT AND NO INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7214632 ↗
• InjuryJan 18, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT AN OM3 LESION WITH NO CALCIFICATION OR TORTUOSITY AND WITH 99 % LESION STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH TWO NON-MEDTRONIC BALLOONS. NO DIFFICULTIES WERE NOTED WHEN LOADING THE DEVICE ONTO THE GUIDEWIRE. THE PHYSICIAN STATED THAT RESISTANCE WAS ENCOUNTERED WHEN TRYING TO PASS THE STENT THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED THAT THE STENT WAS ADVANCED THROUGH THE GUIDE CATHETER AND INTO A PREVIOUSLY PLACED PROXIMAL STENT WHEN IT ENCOUNTERED RESISTANCE. THE RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO PASS THE STENT THROUGH THE MID-DISTAL PORTION OF THE PREVIOUSLY DEPLOYED STENT. WHEN ATTEMPTING TO REMOVE, THE STENT MET FURTHER RESISTANCE WHEN RETRACTING THE DEVICE OVER THE GUIDEWIRE. THE PHYSICIAN HAD TO REMOVE THE SDS, NON MEDTRONIC GUIDE CATHETER AND NON MEDTRONIC GUIDE EXTENSION CATHETER FROM THE PATIENT AS A UNIT. ONCE THE SDS WAS REMOVED, THE PHYSICIAN NOTED THAT THE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7203388 ↗
• MalfunctionNov 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL DIAGONAL BRANCH EXHIBITING 98% STENOSIS. 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/TRAY. NO ISSUES REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED POST-REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THERE WERE TWO WIRES PRESENT- ONE WITH THE STENT, AND THE OTHER WITH A BALLOON. THE PHYSICIAN HAD TRIED TO ADVANCE THE 2.25X12MM RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT ON THE DIAGONAL WIRE. THE BALLOON WAS ON THE LAD WIRE. THE STENT WOULD NOT PASS AND IT THEN DISLODGED AND HUNG UP ON THE ADJACENT BALLOON. IT WAS REPORTED THAT THERE W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040076 ↗
• InjuryNov 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN USED A 2.25 X 12MM RESOLUTE INTEGRITY RX DRUG ELUTING STENT IN A TORTUOUS LESION. NO ISSUES WERE NOTED TO THE PACKAGING AND NO PHYSICAL ANOMALIES WERE NOTED. NORMAL PREP AND PROCEDURAL PROTOCOLS WERE FOLLOWED. IT IS REPORTED THAT THE STENT CAME OFF THE BALLOON IN THE PATIENT'S ARTERY. IT WAS NOTED THE STENT LEFT THE BALLOON WITHOUT BEING DEPLOYED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THE PATIENT UNDERWENT LIMA CABG PROCEDURE IN LIEU OF THIS PROCEDURE. PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN REMARKED THAT THIS EVENT SPED UP THE REQUIREMENT OF THE LIMA CABG PROCEDURE BUT THAT THE PROCEDURE WAS REQUIRED REGARDLESS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7032133 ↗
• MalfunctionAug 18, 2017Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN OBSERVED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS DAMAGED ATTEMPTING TO CROSS A LESION . NO PATIENT INJURY WAS REPORTED AND THE PRODUCT WAS REPLACED WITH ANOTHER RESOLUTE INTEGRITY DRUG ELUTING STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803894 ↗
• InjuryMay 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS INTENDING TO USE A RESOLUTE INTEGRITY DEVICE TO TREAT A LESION IN THE MID TO DISTAL LM CORONARY ARTERY. THE VESSEL WAS NON TORTUOUS WITH MILD CALCIFICATION AND EXHIBITED 10% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY OR WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE PHYSICIAN WAS STENTING THE LAD WITH A RESOLUTE DEVICE OF A DIFFERENT SIZE. UPON INFLATION THE DELIVERY SYSTEM MOVED DUE TO THE PATIENTS HEAVY BREATHING. THE PHYSICIAN ENDED UP STENTING A LITTLE INTO THE LEFT MAIN. IT WAS REPORTED THAT SOME OF THE STENT WAS HANGING OUT. THE PHYSICIAN FLARED THE END OF THE STENT AND BALLOONED THE PROXIMAL END OF THE CIRC WITH AN SC BALLOON AND THEN ATTEMPTED TO STENT THE CIRC. UPON ENTERING THE CIRC WITH THE STENT IT WAS REPORTED THAT THE PHYSICIAN FELT RESISTANCE AND PULLED THE DELIVERY SYSTEM BACK. THE INFLATION DEVICE REMAIN ON

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6559585 ↗
• DeathApr 25, 2017Material Deformation; Positioning Problem; Material Deformation; 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

  MAUDE report 6517867 ↗
• MalfunctionJan 24, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT. THE TARGET LESION WAS IN THE DISTAL RCA. THE TARGET LESION WAS PRE-DILATED. THERE WAS NO DAMAGE TO PACKAGING. THE PACKAGING WAS SEALED. THE DEVICE WAS INSPECTED BEFORE USE. IT WAS NOTED TO BE IN GOOD WORKING ORDER WITH NO DEFECTS COMING OUT OF THE PACKAGE. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO ADVANCE THE DEVICE THROUGH A PROXIMAL CALCIFIED AREA OF THE RCA. THIS PROXIMAL AREA WASN'T DETERMINED AS AN ISSUE WHILE PRE-BALLOONING THE TRUE TARGET DISTAL LESION. THE DEVICE WOULDN'T CROSS THE PROXIMAL RCA, SO IT DIDN'T GET TO THE TARGET LESION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE WAS DAMAGED DURING USE. WHEN IT WAS REMOVED, IT WAS NOTED THAT STENT STRUTS WERE STICKING OUT AND BENT. NO PATIENT INJURY REPORTED. THE TARGET LESION WAS TREATED WITH ANOTHER RESOLUTE INTEGRITY STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6272319 ↗