Resolute Integrity™ RSINT22518UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169037427), received between Mar 2, 2017 and Dec 15, 2017 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION IN A PATIENT'S MID LAD WHICH WAS MODERATELY CALCIFIED AND HAD 90% LESION 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 IDENTIFIED. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. SUFFICIENT TIME WAS GIVEN TO THE BALLOON TO DEFLATE PRIOR ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT. IT WAS REPORTED THAT THE DELIVERY SYSTEM CATHETER BROKE IN HALF DURING REMOVAL POST SUCCESSFUL STENT DEPLOYMENT, AT THE POINT WHERE THE DELIVERY SYSTEM CONNECTS TO HUB. TWO ADDITIONAL INFLATIONS WERE REQUIRED AS THE BALLOON WAS STUCK DURING REMOVAL. IT IS ASSUMED BY THE PHYSICIAN THAT IT MAY HAVE BEEN DUE TO THE CALCIFICATION. THE BALLOON DID NOT PULL BACK AS EASILY AS IT SHOULD HAVE. THERE WERE NO ISSUES ENCOUNTERED WHEN DEFLATING THE DEVICE. NO INTERVENTION WAS NEEDED TO RETRIEVE THE DEVICE. THE DEVICE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120446 ↗
• MalfunctionSep 28, 2017Difficult to Open or Remove Packaging Material; Material Distortion; Difficult to Open or Remove Packaging Material; Material Distortion

  PHYSICIAN INTENDED TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT. IT WAS REPORTED THAT THERE WERE NO ISSUES NOTED TO THE PACKAGING, THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NO ISSUES WERE NOTED; NO DEFECTS IN APPEARANCE APPARENT PRIOR TO ATTEMPTING THE REMOVAL OF THE STYLETTE OR PROTECTIVE SHEATH. RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE PROTECTIVE STYLETTE AND IT WAS STUCK. THE TECH THEN TRIED A SECOND TIME PRIOR TO TEARING THEIR GLOVE. THEIR GLOVE BECAME SNAGGED ON THE STYLETTE AND WAS STUCK ON THE OPEN AREA OF THE STYLET LOOP AND THE PROTECTIVE SHEATH WAS RESISTANT TO REMOVAL AND BECAME MISSHAPEN. A BREAK OCCURRED AT THE TIP. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS NOT KINKED AND RE STRAIGHTENED DURING USE. NEITHER THE TECH OR PHYSICIAN ATTEMPTED TO REMOVE THE PROTECTIVE SHEATH ONCE THE DEVICE HAD BEEN CONTAMINATED. THE DEVICE WAS NOT USED IN THE PATIENT AS THE TORN GLOVE CONTAMINATED THE PRODUCT SO THE TEAM REMOVED IT FROM THE TABLE. THE DEVICE WAS REPLACED WITH A NON MDT PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900363 ↗
• MalfunctionSep 22, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY RX DRUG ELUTING STENT TO TREAT A LESION IN THE OM. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS AND IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS FRAYED. NO PATIENT INJURY REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885680 ↗
• MalfunctionJun 1, 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 -DISTAL RIGHT CORONARY ARTERY. THE LESION WAS REPORTED TO BE SEVERELY TORTUOUS AND MODERATELY CALCIFIED WITH 99% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THERE WERE NO ISSUES REMOVING THE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT BECAME LOOSE DURING ADVANCEMENT TO THE LESION. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT FROM THE PATIENT AS IT WAS ON THE CATHETER. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6603987 ↗
• InjuryMay 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE INTEGRITY STENT WAS IMPLANTED IN THE LCX. APPROXIMATELY 10 MONTHS LATER, THE PATIENT SUFFERED CVA. THE EVENT IS UNRESOLVED AND THE PATIENT CONTINUED WITHOUT TREATMENT.

  Patient problems: Stroke/CVA

  MAUDE report 6568425 ↗
• MalfunctionMar 23, 2017Leak/Splash; Defective Device; Leak/Splash; Defective Device

  PHYSICIAN ATTEMPTED TO USE A RESOLUTE INTEGRITY STENT TO TREAT A MID LAD LESION WITH SEVERE TORTUOSITY AND SEVERE CALCIFICATION. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. LESION WAS PRE-DILATED. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHEN ADVANCING THE STENT AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A GUIDELINER WAS USED DURING THE PROCEDURE FOR SUPPORT. IT IS REPORTED THAT THE BALLOON OF THE DEVICE RUPTURED WHEN THE CATHETER WAS BEING ADVANCED AROUND A 90 DEGREE BEND. NO INFLATION WAS ATTEMPTED. PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6427086 ↗
• MalfunctionMar 2, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE INTEGRITY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS MID LM LESION EXHIBITING 98% STENOSIS. NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. SEVERE CALCIFICATION AND POSSIBLE OLD STENT WERE REPORTED AS ANOMALIES RELATED TO ANATOMY. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND EXCESSIVE FORCE WAS USED. STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PHYSICIAN USED ANOTHER RESOLUTE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6371376 ↗