Resolute Onyx™ RONYX30018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00643169556997), received between Jun 19, 2017 and Aug 20, 2025 — classified as 8 deaths, 46 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING A PROCEDURE, ONE RESOLUTE ONYX DES WAS SUCCESSFULLY IMPLANTED IN THE SEVERELY STENOSED LEFT ANTERIOR DESCENDING ARTERY (LAD). APPROXIMATELY 22 MONTHS LATER, THE PATIENT HAD SEVERE ESOPHAGUS PAIN, AND THE NEXT DAY ATTENDED HOSPITAL WHERE THE PATIENT WAS DIAGNOSED WITH A HEART ATTACK. THE PATIENT WAS SENT TO THE CARDIOLOGY UNIT AND HAD SOME ARTERIES CLEANED OUT AND MEDTRONIC STENTS WERE IMPLANTED. APPROXIMATELY ONE MONTH LATER THE PATIENT ATTENDED AN OUT-PATIENT APPOINTMENT WHERE MORE WORK WAS CARRIED OUT. THE PATIENT THEN HAD ROUTINE 6-MONTH CHECKUPS. APPROXIMATELY 40 AND 17 MONTHS RESPECTIVELY POST MEDTRONIC STENT IMPLANTATION THE PATIENT SUFFERED SEVERE PAIN ACROSS THE TOP OF THEIR CHEST. THE PATIENT WAS HOSPITALIZED WITH ACUTE MYOCARDIAL INFARCTION. THE PATIENT CONTINUED TO HAVE CHEST PAIN WHICH WAS SIMILAR TO THE PREVIOUS MYOCARDIAL INFARCTION (MI). AN ECG WAS SHOWING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT UNDERWENT A PROCEDURE WHERE IT WAS REPORTED THAT THE IMPLANTED MEDTRONIC STENTS HAD DISLODGED, FALLING ACROSS THE ARTERY AND BLOCKING THE BLOOD FLOW. THE PROBLEM WAS CORRECTED DURING THE PROCEDURE. IT WAS NOTED THAT A 2.25 X 18MM NON-MEDT

  Patient problems: Atrial Fibrillation; Cardiac Arrest; Chest Pain; Diaphoresis; Dizziness; Dyspnea; Myocardial Infarction; Obstruction/Occlusion; Ventricular Fibrillation

  MAUDE report 22849789 ↗
• MalfunctionOct 17, 2024Premature Activation; Premature Activation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT DUE TO THE PATIENT'S PHYSIOLOGY, THE DEVICE PREMATURELY RELEASED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469843 ↗
• InjuryMar 21, 2024Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION IN THE PROXIMAL/OSTIUM LEFT MAIN (LM) CORONARY ARTERY /LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POST DEPLOYMENT. THE CAUSATIVE DEVICE WAS A POST DILATION BALLOON. A STENT FRACTURE WAS REPORTED TO HAVE OCCURRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951734 ↗
• InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS, TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE REMOVED FROM THE HOOP WITH NO ISSUES. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE DEVICES WERE PREPPED PER IFU WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT BOTH STENTS DISLODGED DURING DELIVERY TO THE LESION. IT WAS STATED THAT BOTH STENTS DISLODGED IN THE LAD, ONE MID LESION AND THE OTHER MORE DISTAL IN THE LESION. THE STENTS WERE NOT REMOVED AND WERE CRUSHED IN THE ARTERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15348357 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT A DISSECTION OCCURRED AND A LONGER STENT WAS NEEDED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15247975 ↗
• InjuryAug 10, 2022Device 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, SEVERELY CALCIFIED LESION EXHIBITING 60% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED DURING DELIVERY TO AND AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. AN ATTEMPT TO SNARE THE DISLODGED STENT FAILED AND THE STENT WAS CRUSHED USING A BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Insufficient Information

  MAUDE report 15202664 ↗
• MalfunctionAug 10, 2022Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING SENT (DES) TO TREAT THE PROXIMAL RCA. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE DEVICE WAS NOTED TO BE BENT DURING PREP. THE PHYSICIAN DECIDED TO USE THE STENT ANYWAY BUT THE STENT FAILED TO CROSS THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201695 ↗
• MalfunctionJul 21, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT DEPLOYMENT ISSUES OCCURRED AND THE STENT DID NOT DEPLOY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072084 ↗
• InjuryJul 15, 2021Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT 3.0 X 18 MM TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LAD WITH 95% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS DEPLOYED IN THE PROXIMAL LAD ACROSS A D1 SIDE BRANCH WITH NO ISSUES NOTED. A RESOLUTE ONYX 2.75 X 18 MM WAS THEN DEPLOYED IN THE MID LAD, DISTAL TO THE 3.0 X 18 MM STENT AND SLIGHTLY OVERLAPPED THE FIRST STENT PLACED WITH NO ISSUES NOTED. D1 SIDE BRANCH LOST BLOOD FLOW - TIMI 0 AND A SECOND CORONARY GUIDE WIRE WAS PLACED INTO THE LAD. AN ATTEMPT TO CROSS THROUGH THE STENT STRUTS INTO THE D1 SIDE BRANCH WAS UNSUCCESSFUL. THE GUIDE WIRE WAS THEN ADVANCED DOWN THE LAD. A THIRD CORONARY GUIDE WIRE WAS PLACED IN THE LAD AND ADVANCED TO CROSS THROUGH THE

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 12172088 ↗
• MalfunctionJul 8, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LAD ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED 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 NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DETACHED, CRACKED, FRACTURE DURING DELIVERY THROUGH THE VESSEL. THE BREAK/FRACTURE OCCURRED AT THE BALLOON. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN THE PATIENT. THE DEVICE WAS PULLED BACK THROUGH THE GUIDE CATHETER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133403 ↗
• InjuryJun 21, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A PATIENT PRESENTED WITH THROMBUS IN THE RCA. DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE DISTAL RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DEVICE WAS REMOVED WITH A SNARE ALONG WITH THE GUIDE CATHETER. A NON MEDTRONIC STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12031294 ↗
• InjuryMay 21, 2021Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT THE STENTS WERE FRACTURED. IT WAS STATED THAT THE STENTS WERE OVERLAPPING AND THAT A FRACTURE OCCURRED. IT WAS INDICATED THAT THE FRACTURED STENTS WERE REPAIRED. A NON-MEDTRONIC STENT WAS PLACED INSIDE THE FRACTURE WITH NO ISSUES. PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11861666 ↗
• InjuryMay 10, 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 CX. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED FROM ACUTE GI HEMORRHAGE. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED. IT IS UNKNOWN IF THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. CEC ADJUDICATED THE EVENT AS BLEEDING COMPLICATION.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 11796313 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE THREE STENTS WERE IMPLANTED, TWO IN THE LAD AND ONE IN THE CX. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED MI OF LAD AND 100% OCCLUDED LAD. THE PATIENT WAS TREATED WITH MEDICATION AND IMPLANT OF A RESOLUTE ONYX DES.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 11700091 ↗
• 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 11451207 ↗
• MalfunctionMar 8, 2021Device 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 LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THE STENT WAS NOT REMOVED AND WAS EXPANDED IN THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435304 ↗
• InjuryFeb 1, 2021Adverse 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 CX. DURING A STAGED PROCEDURE, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE AND 22 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED FROM CHRONIC TOTAL ARTERY OCCLUSION. EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11257237 ↗
• DeathJan 18, 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 RCA AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE CIRCUMFLEX. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION.

  Patient problems: Insufficient Information

  MAUDE report 11185243 ↗
• DeathJan 11, 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 LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM PULSELESS ELECTRICAL ACTIVITY ARREST AND A POSSIBILITY OF ABDOMINAL BLEEDING WAS ALSO REPORTED. PATIENT WAS NOT ON DAPT 24 HOURS PRIOR TO EVENT. BLOOD TRANSFUSION WAS GIVEN AND RESUSCITATION EFFORTS WERE PERFORMED BUT THE PATIENT DIED. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE BUT NOT RELATED TO ANTIPLATELETS MEDICATION.

  Patient problems: Cardiac Arrest

  MAUDE report 11146340 ↗
• InjuryDec 8, 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 MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT CIRCUMFLEX ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT 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 A FAILED DELIVERY. IT WAS STATED THAT THE STENT WAS NOT REMOVED FROM THE PATIENT AND A NON-MEDTRONIC BALLOON WAS PLACED THROUGH THE UNDEPLOYED STENT AND DEPLOYED THE STENT WHERE IT HAD DISLODGED IN THE LM / PROXIMAL LCX. IT WAS STATED THAT A GUIDELINER, BALLOON AND 2.25MM ONYX STENT HAD CROSSED THE PROXIMAL VESSEL FINE SO NO ISSUES WITH THE 3.00MM ONYX STENT WERE ANTICIPATED. A PILOT WIRE WAS IN USE. WHEN PASSING THE 3.00MM ONYX THROUGH THE VESSEL RESISTANCE WAS ENCOUNTERED IN THE PROXIMAL LCX. IT WAS STATED THAT THE PATIENT HAS A CTO OF THE RIGHT CORONARY ARTERY WHICH IS COMPLETELY DEPENDENT ON COLLATERALS FROM THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND SURGERY HAS NOW BEEN CONSIDERED THE SAFEST OPTION. THE PATIENT WAS REP

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10966225 ↗
• InjurySep 25, 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 CIRCUMFLEX. APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION INVOLVING THE TARGET VESSEL (CX). EVENT WAS TREATED WITH BALLOONING OF THE CX AND MEDICATION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10585182 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED. CEC ADJUDICATED NON-Q-WAVE MI OF THE TARGET VESSEL, MEDRONIC EXTENDED HISTORICAL PERI-PCI.

  Patient problems: Myocardial Infarction

  MAUDE report 10452879 ↗
• MalfunctionJul 30, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT RESISTANCE WAS MET PROXIMAL TO THE LESION AND THE STENT DELIVERY SYSTEM FAILED TO ADVANCE. ON REMOVAL OF THE DEVICE FROM THE PATIENT A STENT STRUT WAS NOTED TO BE LIFTED ON THE PROXIMAL END OF THE STENT. THE LESION WAS THEN PRE-DILATED AND A NEW RESOLUTE ONYX STENT OF THE SAME SIZE WAS USED AND SUCCESSFULLY DEPLOYED TO THE TARGET LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10343942 ↗
• InjuryApr 16, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG LUTING STENT TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9967006 ↗
• DeathMar 18, 2020Adverse 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. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT EXPIRED. CAUSE OF DEATH IS UNKNOWN. CEC ADJUDICATED EVENT AS A CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI PLATELETS.

  Patient problems: Death

  MAUDE report 9847418 ↗