Resolute Integrity™ RSINT22514UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169037410), received between Dec 14, 2016 and Feb 26, 2020 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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.

• MalfunctionFeb 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE INTEGRITY RX CORONARY DRUG ELUTING STENT TO TREAT A DIAGONAL LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS STATED THAT THE STENT CAME OFF THE BALLOON CATHETER INSIDE THE GUIDE CATHETER WHEN REMOVING THE DEVICE FROM THE ARTERY. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT OF THE SAME SIZE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9754966 ↗
• MalfunctionJan 3, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL RCA. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT 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 WAS PLACED IN THE BODY AND PHYSICIAN NOTICED A ¿KINK¿ IN THE STENT. THE PHYSICIAN THEN REMOVED THE STENT FROM THE BODY AND THE STENT WAS NEVER INFLATED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159504 ↗
• MalfunctionNov 29, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND NON-TORTUOUS LESION. 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 HOOP/TRAY. THE LESION WAS PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE TO THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT THE GUIDE LINER WRAPPED AROUND THE STENT AND CRUSHED IT. THE ENTIRE STENT WAS REMOVED WITH THE GUIDE LINER AND NOTHING WAS DEPLOYED IN THE BODY. PATIENT STATUS POST PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7066287 ↗
• MalfunctionOct 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE OF A RESOLUTE INTEGRITY DEVICE, THE DEVICE DETACHED DURING REMOVAL. THE DEVICE WAS REMOVED FROM PACKAGING AND HOOP WITH NO DAMAGE NOTED. DEVICE WAS PREPPED WITH NO ISSUES NOTED. THE PHYSICIAN WAS EMPLOYING A KISSING BALLOON TECHNIQUE USING THE RESOLUTE INTEGRITY, A MEDTRONIC 6FR LAUNCHER AND A NON MDT BALLOON DEVICE. TWO LESIONS WERE BEING TREATED IN THE OBTUSE MARGINAL (DIAGONAL BRANCH). LESION1 WAS NON TORTUOUS AND MILDLY CALCIFIED, LESION 2 WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. BOTH LESIONS HAD 70% STENOSIS. IT WAS REPORTED THAT THE RESOLUTE INTEGRITY WAS BEING PLACED IN LESION 1 AND A NON MDT BALLOON DEVICE IN LESION 2. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. WHILE PHYSICIAN WAS DOING THE KISSING BALLOON IN THE MEDTRONIC 6FR LAUNCHER, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER NO EXCESSIVE FORCE WAS USED. THE STENT WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. PHYSICIAN FELT RESISTANCE WHEN PULLING BACK THE DEVICES INTO THE GUIDE AND THAT IS WHEN HE REMOVED EVERYTHING. THE STENTS CATHETER WAS IN TWO PIECES (STENT WAS ALREADY DEPLOYED PREVIOUS T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6940381 ↗
• MalfunctionAug 17, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, NON CALCIFIED LESION WITH 95% STENOSIS IN THE OSTIUM DIAGONAL BRANCH. 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 NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE DEVICE WOULD NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT IN THE MID LAD AND WHEN REMOVED IT WAS NOTED THAT A STRUT WAS RAISED OUT OF PLACE. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE INTEGRITY DEVICE (2.25X14MM). THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799859 ↗
• MalfunctionJul 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MODERATELY TORTUOUS OSTIUM RCA LESION. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP / TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE STENT DID NOT PASS THROUGH A PREVIOUSLY IMPLANTED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE STENT FAILED TO CROSS THE TARGET LESION AND WAS REMOVED FROM THE PATIENT. NO INTERVENTION WAS REQUIRED. THE PHYSICIAN DILATED THE LESION AND PICKED UP THE RESOLUTE TO MAKE ANOTHER ATTEMPT BUT NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THEY SEARCHED THE FIELD AND SEARCHED THE PATIENT'S BODY THOROUGHLY UNDER FLUORO BUT COULD NOT LOCATE THE STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6700478 ↗
• MalfunctionFeb 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND TORTUOUS PROXIMAL RCA LESION EXHIBITING 80% STENOSIS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN PRE-DILATED THE LESION. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE OR EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS DELIVERED WITH NO ISSUES. SUFFICIENT TIME WAS GIVEN FOR THE BALLOON TO DEFLATE PRIOR TO REMOVING THE DEVICE FROM THE PATIENT. DURING REMOVAL OF THE DELIVERY SYSTEM, OVER THE WIRE, SEPARATED BREAKING INTO TWO PIECES NEAR WHERE THE WIRE EXITS THE RAPID EXCHANGE SEGMENT. ONE PIECE OF THE BROKEN STENT CATHETER WAS REMOVED UPON PULL BACK OUT OF THE BODY AND THE OTHER DETACHED PIECE OF THE STENT CATHETER REMAINED IN THE GUIDE CATHETER AND WHEN THE GUIDE CATHETER WAS REMOVED FROM THE BODY THE REMAINING PIECE WAS TAKEN OUT OF THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6328291 ↗
• InjuryFeb 7, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT. NO DIFFICULTIES REMOVING THE PROTECTIVE SHEATH, DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. LESION WAS PRE-DILATED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED AT THE LESION, BUT NO EXCESSIVE FORCE WAS USED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. IT IS REPORTED THAT DURING WITHDRAWAL OF THE DEVICE IN THE VESSEL/GUIDE CATHETER, THE STENT FELL OFF THE BALLOON AND WAS SNARED SUCCESSFULLY. NO FURTHER CLINICAL SEQUELAE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6306662 ↗
• MalfunctionDec 14, 2016Material Deformation; Material Deformation

  IT WAS REPORTED THAT A STENT STRUT LIFT WHILE USING A RESOLUTE INTEGRITY DRUG ELUTING STENT DURING POSITIONING. NO DAMAGE WAS NOTED TO THE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED AND NO ISSUES WERE REPORTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO EXCESSIVE FORCE WAS REPORTED DURING DELIVERY OF THE DEVICE. THE PHYSICIAN USED ANOTHER DEVICE TO CONTINUE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6173019 ↗