Resolute Onyx™ RONYX30008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169556966), received between Jul 5, 2017 and Apr 21, 2021 — classified as 2 deaths, 19 injuries, 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE LCMA. APPROXIMATELY 13 MONTHS POST PROCEDURE PATIENT SUFFERED A MYOCARDIAL INFARCTION (UNKNOWN VESSEL). PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11699550 ↗
• MalfunctionFeb 15, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OSTIUM LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT IS STATED THAT THE STENT STRIPPED INSIDE THE TELESCOPE AND THE DISLODGED STENT WAS REMOVED WITH THE WHOLE SYSTEM, WHICH WAS DOUBLE WIRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327137 ↗
• DeathMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD. APPROXIMATELY 12 MONTHS LATER THE PATIENT SUFFERED DEATH FROM CARDIOPULMONARY FAILURE. DEATH WAS CLASSIFIED AS NON-SUDDEN CARDIAC DEATH. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. SAFETY COMMENTED DEATH.

  Patient problems: Death; Heart Failure/Congestive Heart Failure; Stenosis

  MAUDE report 9784715 ↗
• InjuryFeb 4, 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 INTO THE LCMA. APPROX 5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED DEMAND ISCHEMIA AND PNEUMONIA. CEC ADJUDICATED THE MI ENDPOINT AS NON-Q-WAVE-MI (VESSEL UNKNOWN) 3RD UDMI SPONTANEOUS. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 9663991 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE TWO RESOLUTE ONYX RX CORONARY DES WERE USED TO TREAT A LESION IN THE LCMA. APPROXIMATELY NINE MONTHS POST PROCEDURE THE PATIENT SUFFERED WORSENING CORONARY ARTERY DISEASE. THE PATIENT WAS TREATED WITH MEDICATION AND PCI.CEC ADJUDICATED THE EVENT AS NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI SPONTANEOUS. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND POSSIBLY RELATED TO THE DEVICE. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9652131 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, SIX RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. PATIENT RECOVERED. CEC ADJUDICATED EVENT A MYOCARDIAL INFARCTION WITH REVASCULARISATION CARRIED OUT IN THE CX AND 2ND OM FOLLOWING STENT THROMBOSIS EVENT TYPE. INVESTIGATOR ASSESSED EVENT IS CAUSALLY RELATED TO DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9640969 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, 5 RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; THREE IN THE RCA AND TWO IN THE LAD. THE FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES WITH NO TREATMENT CARRIED OUT. PATIENT RECOVERED. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI PCI. CEC ASSESSMENT COMMENTED THAT THERE WAS A LARGE SIDE BRANCH OCCLUSION. INVESTIGATOR ASSESSED THE EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9552208 ↗
• InjuryDec 16, 2019Adverse 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. APPROXIMATELY 2 WEEKS LATER THE PATIENT SUFFERED PATCHY BILATERAL PULMONARY ALVEOLAR AND INTERSTITIAL OPACITIES MOST SUSPICIOUS FOR BRONCHOPNEUMONIA.

  Patient problems: Bronchopneumonia; Pneumonia

  MAUDE report 9473553 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX RX CORONARY DES WERE USED TO TREAT A LESION IN THE LCMA. APPROX. NINE MONTHS LATER (B)(6) 2019) THE PATIENT SUFFERED TARGET VESSEL IN-STENT RESTENOSIS TREATED WITH MEDICATION AND STENTING USING A RESOLUTE ONYX DES. THE SITE AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND UNLIKELY TO BE RELATED TO THE DEVICE. THE PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 9260574 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. TWO DAYS LATER A STAGED PROCEDURE WAS CARRIED OUT TO TREAT THE LAD WITH THE IMPLANTATION OF THREE RESOLUTE ONYX DRUG-ELUTING STENTS. POST STAGED PROCEDURE, A PLAQUE SHIFT OCCURRED IN 2ND DIAGONAL WITH TIMI FLOW 1-2 CAUSING ST ELEVATION IN LATERAL LEADS ON TELEMETRY. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI-PCI AND SLOW FLOW IN THE DIAGONAL.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9103993 ↗
• InjurySep 23, 2019Adverse 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 CX AND LCMA. APPROXIMATELY 7.5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED TYPE 2 MI. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION AND MEDICATION AND RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND NOT RELATED TO THE INDEX DEVICE.

  Patient problems: Myocardial Infarction

  MAUDE report 9102613 ↗
• DeathAug 7, 2019Adverse 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 INTO THE LAD. IT WAS REPORTED THE PATIENT DIED. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 8868578 ↗
• InjuryJul 9, 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 USED TO TREAT THE LAD AND CX. DURING A STAGED PROCEDURE THREE DAYS LATER, ONE RESOLUTE ONYX DES WAS USED TO TREAT THE RCA. APPROXIMATELY 2 MONTHS POST PROCEDURES THE PATIENT SUFFERED A STROKE AND WAS TREATED WITH MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR THE ANTI-PLATELET MEDICATION AND THE PATIENT IS RECOVERING.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 8770548 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE CX AND ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE LCMA. APPROX 6 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED ACUTE STROKE. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS NOT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 8639411 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE OM1. POST PROCEDURE ELEVATED TROPONIN WAS OBSERVED. CEC ADJUDICATED Q-WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI, Q-WAVE MI (TARGET VESSEL), SCAI DEFINITION PERI-PCI AND ADJUDICATED STENT THROMBOSIS NO EVENT. IT IS REPORTED THAT THE MI OCCURRED IN THE TARGET VESSEL - THE RCA, AND ALSO IN THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 8338526 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD. ON THE SAME DAY, PATIENT SUFFERED PCI RELATED MYOCARDIAL INFARCTION. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTIPLATELET.

  Patient problems: Myocardial Infarction

  MAUDE report 8320222 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 6 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX. IT WAS REPORTED THAT THE LEFT CIRCUMFLEX ARTERY BECAME COMPLETELY OCCLUDED DURING THE INDEX PROCEDURE AND WAS TREATED WITH PLACEMENT OF A STENT. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTIPLATELET MEDICATION. PATIENT RECOVERED. SAFETY REPORTED PLAQUE SHIFT OCCURRED DURING PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8280818 ↗
• InjuryAug 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RS CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE RCA. IT WAS REPORTED THAT DURING CATHETERIZATION THE STENT WAS PLACED IN THE RCA, THE GUIDE AND STENT DISLODGED DURING INFLATION AND THE STENT DISLODGED AND EMBOLIZED. NO PATIENT INJURY WAS REPORTED - INTERVENTION WAS REQUIRED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7832589 ↗
• InjuryJan 29, 2018Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE OSTIUM OF THE LAD/CX. TORTUOSITY WAS MILD. CALCIFICATION WAS MILD. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED BY SNARE. ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY; THE STENT WAS BELIEVED TO HAVE CAUGHT ON AN OSTIAL LAD STENT. THE DEVICE WAS REPLACED BY ANOTHER MEDTRONIC PRODUCT. PATIENT STATUS POST PROCEDURE IS ALIVE ¿ NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7224142 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE GRAFT PROXIMAL LAD. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A SMALL HEART ATTACK. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 7208852 ↗
• MalfunctionDec 8, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION, LOCATED AT THE MID RIGHT CORONARY ARTERY, EXHIBITING 85% 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. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DESCRIBED THAT THE LESION WAS PRE-DILATED BUT THE PHYSICIAN WAS UNABLE TO GET THE STENT ACROSS THE LESION. THE PHYSICIAN COMPLETED THE PROCEDURE. PATIENT STATUS POST -PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7099296 ↗
• InjurySep 1, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENTS MEDICAL HISTORY INCLUDES CORONARY ARTERY DISEASE. PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE MID RCA. ABNORMALITIES REPORTED IN RELATION TO ANATOMY WERE REPORTED AS VERY ANTERIOR TAKE OFF. THE INTENDED LESION HAD INSTENT RE-STENOSIS, PREVIOUS NON-MDT STENT IMPLANTED. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED POST REMOVAL OF THE SHEATH WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE LESION WAS NOT PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL DURING DELIVERY OF THE DEVICE. RESISTANCE WAS OBSERVED AND EXCESSIVE FORCE WAS USED DURING ATTEMPTED DELIVERY . THE PHYSICIAN OBSERVED THAT THE DEVICE HAD DIFFICULTY IN CROSSING A 70% IN STENT RESTENOSIS (WHICH WAS CALCIFIED). SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION WITH THE STENT PRIOR TO REMOVAL. AFTER THE STENT WOULD NOT CROSS THIS LESION, THE STENT BECAME DISLODGED FROM THE DELIVERY SYSTEM AT THE TIP OF THE GUIDE CATHETER DURING RETRIEVAL. THE STENT REMAINED ON THE WIRE A

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6837286 ↗
• InjuryJul 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG-ELUTING STENT. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE ENCOUNTERED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE INTENDED LESION WAS IN THE PROXIMAL CX. LESION EXHIBITED MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 80 % STENOSIS. THERE WAS MULTIPLE LAYERS OF STENTS IN THE VESSEL. THE LESION WAS PRE-DILATED. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH THE STENT HOWEVER THE STENT FAILED TO CROSS. THIS 3.0 X 8MM STENT PASSED THOUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED DURING DELIVERY. WHEN THE OPERATOR ATTEMPTED TO PULL THAT STENT OUT, THE STENT BECAME DISLODGED FROM THE CATHETER. IT DISLODGED INSIDE AN OLD STENT AT THE OSTIUM CX. THE OPERATOR UNSUCCESSFULLY TRIED TO RETRIEVE THE STENT AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN THEN USED A BALLOON TO OPPOSE THE UNDEPLOYED STENT TO THE VESSEL WALL OF THE PROX CIRC. THE EMBOLISED STENT CAUSED THE PLAQUE TO SHIFT INTO THE LAD. THEN, A FINAL STENT WAS DEPLOYED IN THE OSTIUM OF THE LAD DUE TO PLAQUE SHIFT FROM THE PROXIMAL

  Patient problems: Occlusion; Patient Problem/Medical Problem

  MAUDE report 6685795 ↗