Resolute Integrity™ RSINT25018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169037373), received between Dec 15, 2016 and Jun 1, 2022 — classified as 2 deaths, 3 injuries, 10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE INTEGRITY CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO SNARE THE DISLODGED STENT BUT WAS NOT SUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. IT WAS STATED THAT PCI WAS PERFORMED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14562791 ↗
• MalfunctionNov 4, 2020Inflation Problem; Inflation Problem

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10783688 ↗
• InjuryJan 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH A RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT CALLED TO QUERY WHAT THE IMPLANTED STENT IS MADE FROM. THE PATIENT STATES BEING GENERALLY SICK WITH SHORTNESS OF BREATH SINCE IMPLANTATION OF THE STENT. THE PATIENT STATES BEING DIAGNOSED WITH AN ALLERGY TO COBALT CHROMIUM WHILE BEING TESTED FOR ALLERGIES TO METAL FOR AN UPCOMING KNEE REPLACEMENT. THE PATIENT WAS ADVISED TO SEE AN ALLERGIST TO GET MORE DETAILS AND SPECIFICS AS TO ALLERGIES AND TO WORK WITH THE ALLERGIST AND CARDIOLOGIST FOR A RESOLUTION TO SYMPTOMS. THE PATIENT WAS SENT THE IFU.

  Patient problems: Reaction

  MAUDE report 8230842 ↗
• MalfunctionJul 4, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A RESOLUTE INTEGRITY DRUG ELUTING STENT DEVICE FAILED TO CROSS A 90% STENOSED LESION LOCATED IN THE MID CIRCUMFLEX ARTERY. THE STENT BECAME DEFORMED WITH A BENT STRUT DURING THE ATTEMPTED PLACEMENT AT AN EXTREME ANGLE. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED USING AN NC BALLOON. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662399 ↗
• MalfunctionSep 15, 2017Inflation Problem; Inflation Problem

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION WITH 85% STENOSIS IN THE MID CIRCUMFLEX ARTERY. 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 PERFORMED WITH NO ISSUES. IT IS REPORTED THAT THE STENT WENT INTO THE CIRCUMFLEX WITH NO ISSUES BUT THE BALLOON WOULD NOT INFLATE ON THE FIRST INFLATION DURING STENT DEPLOYMENT. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM TO INSPECT AND NOTED THAT THE CONTRAST WAS LEAKING FROM THE CATHETER PROXIMAL TO THE STENT BUT BEFORE THE RX PORTION OF THE DEVICE. THERE WAS NO RESISTANCE OBSERVED DURING DELIVERY OR WITHDRAWAL OF THE DEVICE FROM THE LESION SITE AND NO EXCESSIVE FORCE WAS USED. DURING INSPECTION OF THE DEVICE THE DISTAL HUB OF THE CATHETER BROKE OFF (OUTSIDE THE PATIENT¿S BODY). THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE INTEGRITY DEVICE OF THE SAME SIZE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6867902 ↗
• MalfunctionSep 8, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID OBTUSE MARGINAL (OM) WHICH WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES ENCOUNTERED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT WHEN THE STENT WAS BEING POSITIONED IN THE TARGET LESION, ONE OF THE STRUTS APPEARED TO CATCH SOME OF THE CALCIFICATION AND WHEN PUSHED BECAME DEFORMED. THE PHYSICIAN DID COMPLETE THE PROCEDURE. THE SAME SIZE/MODEL STENT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851230 ↗
• MalfunctionSep 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID CX. IT WAS REPORTED THAT THE PHYSICIAN HAD TO REMOVE THE GUIDELINER AND WHEN THE STENT WAS REMOVED, IT WAS NOTICED THAT THE STENT WAS COMING OFF THE BALLOON. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6847649 ↗
• MalfunctionJun 28, 2017Leak/Splash; Leak/Splash

  A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS USED TO TREAT A MID RCA LESION EXHIBITING SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 95% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING NOR WERE THERE ANY ISSUES WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. A NON MDT GUIDE WIRE WAS CUT DOWN FROM A 300CM TO AROUND 180CM WIRE USING STERILE SNIPS. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM MAY HAVE BEEN DAMAGED DURING THE LOADING PROCESS. THERE WAS DIFFICULTY WHEN LOADING OTHER PRODUCTS ON THE WIRE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE BALLOON HAD DEFLATION DIFFICULTIES AT THE LESION SITE AND THE BALLOON BURST DURING STENT DEPLOYMENT AT 14 ATMS, DURING THE 1ST INFLATION. NO INTERVENTIONS WERE REQUIRED. A 2.5X15 NC SPRINTER WAS USED TO ENSURE THE VESSEL WAS DILATED, AND ANGIOGRAPHICALLY IT LOOKED GOOD. THE BALLOON AND DELIVERY SYSTEM WHERE REMOVED AND DID NOT CAUSE HARM TO THE PATIENT. WHEN THE SYSTEM CAME OUT THE BALLOON APPEARED PARTIALLY INFLATED. THE BALLOON AND INFLATIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6672594 ↗
• InjuryMar 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY. NO ISSUES REMOVING THE SHEATH. DEVICE WAS INSPECTED WITH NO ISSUES NOTED. LESION WAS PRE-DILATED. INFLATION DEVICE REMAINED ON NEUTRAL DURING DELIVERY OF THE STENT. DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED ADVANCING THE DEVICE TO THE LESION, BUT NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING WITHDRAWAL OF THE DEVICE IN THE VESSEL/GUIDE CATHETER, PART OF THE STENT FELL OFF DUE TO AN ISSUE WITH THE GUIDELINER NOT THE RESOLUTE STENT. THIS OCCURRED IN THE LEFT MAIN CORONARY ARTERY. THE PHYSICIAN RETRIEVED THE STENT WITH A SNARE AND THE PATIENT WAS REPORTED TO BE 'FINE'.

  Patient problems: Device Embedded In Tissue or Plaque; Patient Problem/Medical Problem; Stroke/CVA

  MAUDE report 6401878 ↗
• MalfunctionFeb 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY STENT TO TREAT A SLIGHTLY CALCIFIED AND NON-TORTUOUS MID LAD LESION. A RADIAL APPROACH WAS USED. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. NO ISSUES NOTED REMOVING THE PROTECTIVE SHEATH. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH THE CELL OF A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND VERY LITTLE FORCE USED. IT WAS REPORTED THAT THE STENT DISLODGED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT THE STENT WAS NOT REMOVED AND IS LODGED IN THE ULNAR VESSEL IN THE ARM. IT IS REPORTED THAT THE PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6306703 ↗
• MalfunctionJan 31, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A TORTUOUS AND CALCIFIED LESION. THE LESION WAS NOT PRE-DILATED. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION, AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO CROSS THE TARGET LESION AND WAS DAMAGED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A NON MEDTRONIC STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6289359 ↗
• MalfunctionJan 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO IMPLANT A RESOLUTE INTEGRITY RX DRUG ELUTING STENT IN THE PROXIMAL RCA-WITH MODERATE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS OF A PATIENT. THERE WERE NO ANATOMICAL ABNORMALITIES REPORTED AND THE PATIENT'S MEDICAL HISTORY SPECIFIED THERE WERE NO KNOWN ALLERGIES. NO DAMAGE WAS NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES REPORTED. NEGATIVE PREP WAS NOT PERFORMED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE IS REPORTED TO HAVE BEEN USED. STENT DISLODGEMENT DURING REMOVAL IS REPORTED TO HAVE OCCURRED FOLLOWING FAILURE OF DEVICE TO CROSS THE LESION. IT IS UNKNOWN IF THE STENT DISLODGED INSIDE OR OUTSIDE THE BODY. NO INJURY IS REPORTED TO HAVE BEEN CAUSED TO THE PATIENT. PATIENT RETURNED 2 DAYS LATER AND A PCI WAS PERFORMED ON THE PROXIMAL RCA USING A NON-MDT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6248826 ↗
• MalfunctionDec 20, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LAD LESION EXHIBITING 80% STENOSIS. NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. NO ISSUES NOTED REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND NO EXCESSIVE FORCE USED. DURING STENT DEPLOYMENT THE RESOLUTE INTEGRITY STENT SEEMED TO JUMP FORWARD WHEN THE PHYSICIAN INFLATED THE BALLOON TO 16ATM. A NON-MDT GUIDEWIRE WAS USED AND THE STENT WAS POST DILATED USING A NC EUPHORA TO POST DILATE. NO CLINICAL SEQUELAE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6188606 ↗
• 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 3.0 MM X 22 MM 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 LOOSE 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 2.50 MM X 18 MM STENTS IN THE CIRCUMFLEX TO SALVAGE THE ARTERY. BOTH STENTS PASSED THROUGH PREVIOUSLY DEPLOYED STENTS. NO RESISTANCE OR EXCESSIVE FORC

  Patient problems: Death

  MAUDE report 6177357 ↗
• 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 LOOSE 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 US

  Patient problems: Death

  MAUDE report 6176777 ↗