Resolute Onyx™ RONYX40030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169557208), received between Dec 14, 2017 and Oct 7, 2021 — classified as 1 death, 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2021Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE DEVICE SHAFT WAS BROKEN. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589216 ↗
• MalfunctionSep 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 A STENT DISLODGMENT OCCURRED DURING REMOVAL OF THE DEVICE AFTER IT FAILED TO BE DELIVERED. THE STENT WAS STILL IN THE GUIDEWIRE AND WAS REMOVED. IT WAS REPORTED THAT THE DISLODGMENT WAS DUE TO A VERY CALCIFIED RCA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554477 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 11 MONTHS POST PROCEDURE PATIENT SUFFERED OF RESPIRATORY FAILURE AND MYOCARDIAL INFARCTION (UNKNOWN VESSEL). PATIENT WAS TREATED WITH MEDICATION AND INTUBATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11594376 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 12 MONTHS POST PROCEDURE PATIENT SUFFERED GI BLEEDING. THE PATIENT HAD BLOODY STOOL. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11560378 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED; ONE IN THE L-PDA AND ONE IN THE CIRCUMFLEX. TWO RESOLUTE ONYX DES WERE IMPLANTED DURING A REVASC PROCEDURE, ONE IN THE CX AND ONE IN THE OM. APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CHEST DISCOMFORT WITH EXERTION. PATIENT WAS HOSPITALIZED AND PTCA WITH BRACHYTHERAPY OF THE CX CARRIED OUT. A NON-MEDTRONIC BALLOON WAS USED. PATIENT RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. STENT THROMBOSIS IN THE CIRCUMFLEX (CASS #19) WAS CONFIRMED BY ANGIO. EVENT WAS TREATED WITH POBA. CEC ADJUDICATED THE EVENT AS TLR PERCUTANEOUS INTERVENTION OF THE CX.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10873998 ↗
• DeathMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED : ONE IN THE IN THE R-PDA AND TWO IN THE RCA. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT DEATH OCCURRED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED EVENT.

  Patient problems: Death

  MAUDE report 9834660 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM GI BLEED. EVENT WAS TREATED WITH BLOOD TRANSFUSION. PATIENT WAS NOT ON DAPT 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT PROBABLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 9786022 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED - ONE INTO THE L-PDA AND ONE INTO THE CX. DURING A REVASCULARIZATION PROCEDURE TWO RESOLUTE ONYX WERE IMPLANTED IN THE CX AND OM3. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE AND 6 MONTHS POST REVSACULARIZATION PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION . EVENT WAS TREATED WITH POBA IN THE CX. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 9659687 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD AND RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT SUFFERED HEMORRHAGIC SHOCK DUE TO GI BLEED AND WAS TREATED WITH BLOOD TRANSFUSION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9626509 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM A HEMORRHAGIC STROKE. EVENT WAS TREATED WITH MEDICATION. PATIENT DIED. DEATH WAS CLASSIFIED AS NON-CARDIAC DEATH. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 9595492 ↗
• MalfunctionSep 3, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION IN THE MID DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS ADVANCED THROUGH A GUIDLINER. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE WAS UNABLE TO CROSS THE LESION AND WAS REMOVED AND INSPECTED. ON INSPECTION, STENT STRUTS ON THE DISTAL END WERE LIFTED AND FLARED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8955683 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 1ST OBTUSE MARGINAL AND LAD. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED MI IN THE SETTING OF ACUTE PULMONARY EMBOLISM AND PNEUMONIA. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8914548 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE RCA. APPROXIMATELY 22.5 MONTHS POST PROCEDURE PATIENT SUFFERED TARGET VESSEL NSTEMI OF THE RCA. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR TO THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND THE ANTI-PLATELET MEDICATION. THE PATIENT IS RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8815041 ↗
• MalfunctionMar 20, 2019Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED AND ROTOBLATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THERE WERE INFLATION DIFFICULTIES DURING STENT DEPLOYMENT. IT WAS INDICATED THAT THERE WAS A LEAK IN THE BALLOON PRIOR TO ATTEMPTING TO INFLATE THE DEVICE AND THE STENT DELIVERY SYSTEM BALLOON WAS NOTED TO HAVE A HOLE IN IT. IT WAS INDICATED THAT THE HOLE MAY HAVE BEEN CAUSED FROM EITHER SHARP PLAQUE OR OCCURRED WHEN LOADING IT. IT WAS REPORTED THAT SMALL PRESSURE WAS NOTED FROM THE START OF INFLATION THEREFORE THE INFLATOR WAS PUSHED AS FAST AS POSSIBLE ALLOWING ENOUGH PRESSURE TO GET THE STENT OFF THE BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436505 ↗
• InjuryJan 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND NON-TORTUOUS LESION LOCATED AT THE MID CIRCUMFLEX ARTERY EXHIBITING 99% STENOSIS. THE ANATOMY WAS DESCRIBED AS DIFFICULT. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE INSPECTED WITH NO ISSUES NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS NOT INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS REMOVED USING A SNARE. PATIENT STATUS POST PROCEDURE IS ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7203386 ↗
• MalfunctionDec 15, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE RCA. IT WAS REPORTED THAT THE RESOLUTE ONYX WOULD NOT CROSS THE LESION AND WHEN REMOVED FROM THE BODY, THE STENT WAS DAMAGED AND COULD NOT BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120378 ↗
• InjuryDec 14, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN USED A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED BETWEEN THE LEFT MAIN ARTERY AND THE OBTUSE MARGINAL OSTIUM, EXHIBITING 100% STENOSIS (CTO). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS NOT PERFORMED. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DESCRIBED THAT THE PHYSICIAN COULDN'T CROSS THE LESION, SO PULLED BACK ON THE STENT, AND DESCRIBED THAT THERE WERE NO DIFFICULTIES APPARENT DURING REMOVAL. HOWEVER THE PHYSICIAN THEN SAW THAT ONLY THE BALLOON CAME OUT. THE STENT WAS LEFT IN THE LEFT MAIN, UN-DEPLOYED. THE DISLODGED STENT WAS NOT REMOVED. IT WAS STATED THAT THE PHYSICIAN CARRIED OUT INTERVENTION BY PASSING A NON-MEDTRONIC BALLOON THROUGH THE STENT. FOUR INFLATIONS WERE MADE TO EXPAND THE STENT IN THE LEFT MAIN AND MARGINAL, STARTING DISTALLY AND COMING

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7116327 ↗