Resolute Onyx™ RONYX27530UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169556935), received between Sep 13, 2017 and Aug 18, 2022 — classified as 2 deaths, 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING ADVANCEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15247766 ↗
• InjuryMay 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE 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 AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT INJURY REPORTED.  THE PHYSICIAN STATED THAT THIS WAS NOT A PRODUCT ISSUE AS THE LESION SHOULD HAVE BETTER PREPPED BEFORE ATTEMPTING TO STENT AND THAT CSI SHOULD HAVE BEEN PERFORMED ON THE LESION BEFORE ATTEMPTING TO STENT.

  Patient problems: Insufficient Information

  MAUDE report 14494686 ↗
• InjuryJun 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT IS STATED THAT THE DEVICE WAS REMOVED FROM THE PATIENT WITH A SNARE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12007601 ↗
• InjuryMar 23, 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 LAD AND ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LCMA. APPROXIMATELY 5 DAYS POST PROCEDURE PATIENT SUFFERED GASTROINTESTINAL BLEED . GI BLEEDING WAS SUSPECTED AS THE PATIENT HAD BLACK STOOLS AND GENERALIZED WEAKNESS. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE EVENT WAS TREATED WITH BLOOD TRANSFUSION, MEDICATION AND SURGICAL PROCEDURE. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11552068 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE ONE RESOLUTE ONYX RX DES WAS IMPLANTED IN THE MID LAD. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH CHEST PAIN DISCOMFORT, SHORTNESS OF BREATH AFTER TAKING BOWEL PREP FOR COLONOSCOPY, HE WAS SCHEDULED FOR THE COLONOSCOPY ON THE SAME DAY. CARDIOLOGY WAS CONSULTED. NSTEMI IN SETTING OF AFIB W/RVR. PATIENT WAS TREATED WITH MEDICATION. VENTRICULAR RATE CAME UNDER CONTROL AND THE PATIENT HAS RECOVERED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DRUGS OR THE DEVICE, THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE MEDICATION BUT POSSIBLE RELATED TO THE DEVICE.

  Patient problems: Myocardial Infarction

  MAUDE report 10513104 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE TWO RESOLUTE ONYX DES STENT WERE IMPLANTED IN THE LAD. APPROXIMATELY 32 MONTHS LATER THE PATIENT WAS ADMITTED TO (B)(6) WITH STROKE SYMPTOMS. RIGHT SIDE WAS DOWN. PATIENT WAS NUMB, WALKS WITH WALKER, SHE'S WAS MORE FORGETFUL AND VISION WAS WEAKER. SPEECH WAS PROGRESSING ALONG WITH RIGHT SIDE OF FACE NUMB. PATIENT WAS ON MEDICATION. THE PATIENT WAS TREATED WITH HOSPITALIZATION. THE PATIENT IS RECOVERING. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION OR THE DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 10475618 ↗
• MalfunctionApr 17, 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 LESION. IT WAS REPORTED THAT THERE WAS A KINK ON THE DISTAL SHAFT AND THE HYPOTUBE. IT WAS ALSO REPORTED THAT THERE WAS NO STENT ON THE BALLOON. NO PATIENT INJURY WAS REPORTED. UPON ANALYSIS IT WAS NOTED THAT THE BALLOON HAD BEEN INFLATED AND THIS MAY HAVE OCCURRED IN VIVO. IT WAS INDICATED THAT THE STENT DISLODGED OFF THE BALLOON IN VIVO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9971517 ↗
• DeathApr 15, 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 1ST DIAGONAL AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LCMA. ANOTHER RESOLUTE ONYX DES WAS ALSO IMPLANTED. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM VENTRICULAR TACHYCARDIA AND DIED. EVENT WAS TREATED WITH MEDICATION, CPR AND ICD FIRED SHOCK. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9961677 ↗
• InjurySep 16, 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 IMPLANTED IN THE LAD. APPROXIMATELY SIX MONTHS LATER THE PATIENT HAD INTRAPARENCHYMAL HAEMORRHAGES. THE PATIENT WAS NOT TAKING DAPT AT THE TIME OF THE EVENT. APPROXIMATELY ONE WEEK LATER THE PATIENT DIED. THE DEATH WAS CLASSIFIED AS NON-CARDIAC. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE AND ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 9069998 ↗
• DeathAug 2, 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. IT WAS REPORTED THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 8854150 ↗
• MalfunctionJul 29, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED. THE DEVICE COULD NOT CROSS THE LESION, IT WAS REMOVED AND A BUDDY WIRE SYSTEM WAS ATTEMPTED BUT THE DEVICE WOULD STILL NOT CROSS. THE LESION WAS PREDILATED A SECOND TIME USING A NON COMPLIANT BALLOON HOWEVER THE DEVICE STILL COULD NOT CROSS. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETE USING TWO 2.75 X 15 MM RESOLUTE ONYX STENTS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8835497 ↗
• InjuryJul 5, 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 CX. APPROXIMATELY 4 MONTHS POST PROCEDURE PATIENT SUFFERED NSTEMI. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR TO THE ANTI-PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATIONS. THE PATIENT IS RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8763419 ↗
• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE LAD WAS TREATED. APPROX 13 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED RECTAL BLEEDING. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE EVENT WAS TREATED WITH MEDICATION. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 8607119 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE CX ARTERY. APPROXIMATELY THREE WEEKS POST PROCEDURE, THE PATIENT PRESENTED WITH NSTEMI TYPE 2. DEMAND ISCHEMIA OCCURRED FROM HYPERTENSION AND ACUTE RESPIRATORY FAILURE. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8590260 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX CORONARY DES WAS IMPLANTED IN THE LAD. APPROXIMATELY THREE MONTHS LATER THE PATIENT PRESENTED WITH INCREASING CHEST PAIN AND WAS DIAGNOSED WITH A NON STEMI (VESSEL UNKNOWN). CARDIAC ENZYMES WERE UP AND WERE TRENDING UP PRE PROCEDURE. THE PATIENT WAS TREATED WITH NON TARGET VESSEL PCI BY STENTING THE RCA. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8568028 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL PROCEDURE, TWO RESOLUTE ONYX DRUG ELUTING STENTS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY, EXHIBITING 95% STENOSIS. THE LESION WAS IDENTIFIED AS DIFFUSE AND MILDLY CALCIFIED. THE LESION SHOWED MILD ANGULATION AND MILD TORTUOSITY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE 2.75 X 30MM STENT WAS DEPLOYED AT 12 ATMS, INFLATED ONCE, AND THE 3.0 X 12MM STENT WAS INFLATED ONCE AND DEPLOYED AT 15 ATMS. APPROX 8 DAYS POST PROCEDURE THE PATIENT PRESENTED WITH A STEMI. LESION IS BEING TREATED FOR IN STENT RESTENOSIS, THROMBUS PRESENT. THE LESION WAS TREATED WITH A NON-MEDTRONIC STENT AND BALLOONS. THE PATIENT IS REPORTED AS BEING ALIVE WITHOUT INJURY.

  Patient problems: Myocardial Infarction; Stenosis; Thrombus

  MAUDE report 7555902 ↗
• InjuryMay 22, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  PREVIOUSLY TWO RESOLUTE ONYX RX DRUG ELUTING STENTS WERE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT THE LESION WAS EXTREMELY CALCIFIED. HAZINESS WAS OBSERVED POST IMPLANTATION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT THE PATIENT PRESENTED LESS THAN TWO WEEKS POST STENT PLACEMENT WITH POSSIBLE THROMBUS OR OBSTRUCTION BETWEEN THE TWO IMPLANTED RESOLUTE ONYX STENTS. IT WAS INDICATED THAT THE STENTS WERE OVERLAPPING AT IMPLANT. AT FOLLOW UP, TISSUE PROLAPSE WAS OBSERVED BETWEEN THE TWO STENTS. A CONCERN WAS EXPRESSED THAT THE STENT MAY HAVE FRACTURED AT THE POINT OF OVERLAP. THERE WAS A QUESTION AS TO THE PATIENT'S COMPLIANCE TO ADAPT. IT IS BELIEVED THE PATIENT MAY HAVE STOPPED TAKING IT AND THAT THE TISSUE PROLAPSE OBSERVED MAY HAVE BEEN THROMBUS. A NON

  Patient problems: Occlusion; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7532530 ↗
• InjurySep 13, 2017Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION LOCATED DISTAL RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS REPORTED TO BE MILDLY TORTUOUS, MODERATELY CALCIFIED WITH 80% STENOSIS. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NO DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE PROTECTIVE SHEATH AND THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES ENCOUNTERED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED DURING POSITIONING. THE PROXIMAL END OF THE STENT GOT COMPRESSED DURING DELIVERY TO THE LESION. IT IS UNKNOWN HOW THIS OCCURRED BUT IT WAS POTENTIALLY DUE TO THE TIP OF THE GUIDE CATHETER. THE PROXIMAL END GOT FLARED OUT AND WOULDN'T COME BACK INTO T

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6860940 ↗