Resolute Onyx™ RONYX22508UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169556690), received between Sep 22, 2017 and Oct 19, 2021 — classified as 3 deaths, 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• DeathOct 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION IN THE MID CIRCUMFLEX (CX) ARTERY. 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. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT IN THE LAD. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS DISLODGED FROM DELIVERY SYSTEM AFTER ATTEMPTING TO STENT THE MID CIRCUMFLEX AND WAS FOUND LOCATED IN THE MID CIRCUMFLEX. A BALLOON WAS USED TO DO A SMALL INFLATION TO TRY RETRIEVE THE STENT OUT OF THE VESSEL, BUT WAS UNSUCCESSFUL. A MEDTRONIC GOOSE NECK SNARE WAS USED TO TRY TO SNARE THE STENT, BUT THE STENT COULD NOT BE RETRIEVED. TWO WIRES AND 7F NON-MDT GUIDE EXTENSION CATHETER WERE USED TO TRY TO RETRIEVE THE STENT. THE STENT WAS ABLE TO BE MOVED TO THE LEFT MAIN LOCATION, BUT THE TWO WIRES AND STENT WERE REPORTED AS BEING ¿STUCK¿ IN THE LEFT MAIN. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT WAS INTUBATED.

  Patient problems: Insufficient Information

  MAUDE report 12656899 ↗
• 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 11699574 ↗
• DeathMar 15, 2021Adverse 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 1ST DIAGONAL. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED RESPIRATORY FAILURE, SEPTIC SHOCK, PULSELESS ELECTRICAL ACTIVITY AND RENAL FAILURE. PATIENT WAS INTUBATED AND DIALYSIS WAS STARTED BUT THE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Cardiac Arrest; Sepsis

  MAUDE report 11479461 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE LAD, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA, ONE RESOLUTE ONYX WAS IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX WAS IMPLANTED IN THE 1ST RPL. SIX NC EUPHORA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED MYOCARDIAL INFARCTION INVOLVING THE RCA (TARGET VESSEL). ANGIOGRAM REVEALED IN-STENT RESTENOSIS. THE EVENT WAS TREATED WITH TARGET LESION REVASCULARIZATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11451224 ↗
• InjuryFeb 18, 2021Adverse 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 1ST-RPL. APPROXIMATELY 9 DAYS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CHEST PAIN - UNSPECIFIED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION (VESSEL UNKNOWN). PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11342091 ↗
• InjuryJan 5, 2021Adverse 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 LCMA. IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED INSTENT THROMBOSIS NON TARGET LESION. IT IS REPORTED THAT THE STENT THROMBOSIS WAS IN THE RAMUS IN A NON TARGET VESSEL AND WAS RESTENOSIS FROM PREVIOUS PTCA. THE PATIENT WAS TREATED WITH A BALLOON ANGIOPLASTY OF THE RAMUS. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND INDEX DEVICE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11115741 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A SNARE. IT WAS STATED THAT TANGLED WIRED AND USE OF GUIDE EXTENSION CATHETER BELIEVED BY PHYSICIAN TO HAVE CAUSED DISLODGMENT AND THERE IS NO NEGATIVE PRODUCT ACCUSATIONS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10911222 ↗
• 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 9663993 ↗
• 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 9652126 ↗
• 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 9260614 ↗
• InjuryJul 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE IT WAS INTENDED TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED BY PULLING IT INTO THE GUIDE WITH A BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8766908 ↗
• DeathApr 2, 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 2ND OBTUSE MARGINAL. APPROX 13 DAYS POST INDEX PROCEDURE THE PATIENT DIED. 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 OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 8473980 ↗
• MalfunctionMar 27, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, A PATIENT WAS IMPLANTED WITH A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED DURING ADVANCEMENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS IMPLANTED 3 DAYS PAST ITS EXPIRY DATE. THE PATIENT IS REPORTED TO BE ALIVE WITHOUT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456224 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA AND THAT 3 RETRACTED. IT IS REPORTED THAT A SERIOUS INJURY OCCURRED. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8417440 ↗
• InjuryFeb 13, 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 1ST DIAGONAL BRANCH. IT WAS REPORTED THAT PLAQUE / CARINA SHIFT OCCURRED. THIS WAS TREATED BY IMPLANTATION OF ONE RESOLUTE ONYX STENT INTO THE 1ST DIAGONAL BRANCH AND ONE RESOLUTE ONYX STENT INTO THE LAD. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS CAUSALLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8334632 ↗
• InjuryApr 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE DISTAL RCA. IT WAS REPORTED THAT THERE WAS NOT MUCH CALCIFICATION BUT THE LESION WAS VERY TIGHT, WITH 90% STENOSIS, AND AN APPROX 90 DEGREE BEND. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. NO DIFFICULTIES WERE REPORTED REGARDING REMOVING THE PROTECTIVE SHEATH. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE RESOLUTE ONYX WAS INTENDED TO BE IMPLANTED DISTAL TO A PREVIOUS STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE STENT COULD NOT BE ADVANCED DISTALLY ENOUGH WITH REASONABLE PUSH AND THEREFORE IT WAS DECIDED TO BRING IT BACK AND DO MORE PREDILATATION. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. ATTEMPTS WERE MADE TO DELIVER THE STENT TO THE LESION, TWICE, WITHOUT SUCCESS. THE PHYSICIAN REMOVED THE DEVICE AFTER THE SECOND ATTEMPT AND CHANGED THE GUIDE CATHETER. IT IS REPORTED THAT WHEN ATTEMPTING TO CROSS FOR THE THIRD TIME THE STENT DISLODGED. THE DISLODGED STENT WAS RETRIEVED USI

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7435607 ↗
• MalfunctionMar 30, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. A 0.014 WIRE WAS USED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT THE DEVICE COULD NOT PASS THROUGH THE LESION AND WHEN THE PHYSICIAN PULLED THE UN-DEPLOYED STENT BACK IN THE UNKNOWN BRAND GUIDE CATHETER, IT CAUGHT ON THE GUIDE CATHETER TIP AND DISLODGED. THE STENT ENDED UP DISTAL IN THE PERIPHERY. NO INTERVENTION WAS CARRIED OUT. THE STENT WAS NOT CRUSHED OR SNARED. THE STENT REMAINS IN THE PATIENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384491 ↗
• InjuryJan 22, 2018Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  THE PHYSICIAN ATTEMPTED TO TREAT TWO MODERATELY TORTUOUS, MODERATELY CALCIFIED LESIONS IN THE MID LAD, THE PROXIMAL LESION HAD 70% STENOSIS AND THE DISTAL LESION HAD 90% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. BOTH LESIONS WERE PRE-DILATED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING, AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES. A 2.5X15MM RESOLUTE ONYX STENT WAS ATTEMPTED FOR USE IN THE MOST DISTAL LESION BUT IT FAILED TO CROSS SO THE PHYSICIAN DEPLOYED IT IN THE MORE PROXIMAL LESION (PLI 30). FURTHER PRE-DILATION WAS PERFORMED AND A 2.75X12MM RESOLUTE ONYX WAS SUCCESSFULLY DEPLOYED IN THE DISTAL LESION. THERE WAS AN 8MM GAP BETWEEN THE TWO STENTS SO THE PHYSICIAN DECIDED TO DEPLOY A THIRD STENT AT THE SITE. A 2.25X12MM RESOLUTE ONYX (PLI-20) WAS ATTEMPTED BUT HAD DIFFICULTY GETTING THROUGH THE FIRST PROXIMAL STENT, EXCESSIVE FORCE WAS USED AND WHEN REMOVED THE STENT STRUTS WERE NOTED TO BE DEFORMED. A PTCA BALLOON WAS USED TO DILATE THE AREA. A 2.25X08MM RESOLUTE ONYX (PLI-10) DEVICE WAS ATTEMPTED AND WAS SUCCESSFUL IN REACHING THE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7208845 ↗
• InjuryJan 5, 2018Adverse 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 LCX. APPROXIMATELY 1 MONTH POST PROCEDURE, STENT THROMBOSIS WAS FOUND IN THE ONYX STENTS. INVESTIGATOR ASSESSED THAT EVENT IS PROBABLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION. PATIENT RECOVERED.

  Patient problems: Occlusion; Thrombus

  MAUDE report 7166999 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE PATIENT WAS TREATED WITH TWO RESOLUTE ONYX DRUG ELUTING STENTS, ONE IN THE 1ST LEFT POSTERIOR LATERAL AND THE 2ND IN THE CIRCUMFLEX ARTERY. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE THE PATIENT SUFFERED A NSTEMI. PATIENT WAS HOSPITALISED.

  Patient problems: Myocardial Infarction; Patient Problem/Medical Problem

  MAUDE report 6927965 ↗
• InjurySep 22, 2017Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  THE TARGET LESION WAS LOCATED IN THE 1ST OM AND EXHIBITED 80% STENOSIS PRIOR TO PRE-DILATION (IN-STENT RESTENOSIS OF A DRUG ELUTING STENT). THE LESION WAS PRE-DILATED. DURING DELIVERY OF THE RESOLUTE ONYX STENT THAT WAS PLANNED FOR THE 1ST OM, IT DISLODGED FROM THE BALLOON WITHIN A PREVIOUSLY DEPLOYED STENT IN THE PROXIMAL CIRCUMFLEX. THE STENT GOT CAUGHT ON THE GUIDELINER AND HAD TO BE PREMATURELY DEPLOYED IN THE PROXIMAL LCX. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6886705 ↗