Resolute Onyx™ RONYX35018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00643169557086), received between Jun 29, 2017 and Feb 20, 2023 — classified as 6 deaths, 20 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (18 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 52 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX WERE IMPLANTED ON THE (B)(6) 2022. THE PATIENT REPORTED A RASH ALL OVER THE BODY 14 DAYS AFTER THE TWO STENTS WERE IMPLANTED. THE PATIENT PREVIOUSLY HAD TWO NON-MEDTRONIC STENT IMPLANTED ON THE (B)(6) 2022 WITH NO ISSUES. THE CARDIOLOGIST AND DERMATOLOGIST WERE INFORMED OF THE RASH AND THE PATIENT HAS BEEN REFERRED TO THEIR DOCTOR. THE PATIENT UNDERWENT SKIN TESTING WHICH WAS POSITIVE FOR COBALT. THE PATIENT HAS KNOWN PENICILLIN AND SHRIMP ALLERGY. A ZOTOROLIMUS ALLERGY IS SUSPECTED, HOWEVER, IT WAS NOT KNOWN BEFORE. MEDICATIONS OMEPRIZOL AND LIPITOR HAVE BEEN DISCONTINUED, AND OTHER MEDICATIONS HAVE BEEN SWITCHED AROUND TO HELP, BUT THE RASH PERSISTED. THE PATIENT IS TAKING AN ANTIHISTAMINE ZYRTEC FOR THEIR SYMPTOMS. THE RASH IS SINCE IMPROVED AND THE PATIENT IS DOING FINE.

  Patient problems: Local Reaction; Rash

  MAUDE report 16402748 ↗
• MalfunctionNov 9, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758868 ↗
• MalfunctionAug 3, 2022Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, NON CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT AT 16ATM AND THE STENT COULD NOT BE DEPLOYED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156524 ↗
• MalfunctionJul 21, 2022Material Deformation; Material Deformation

  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 THE DEVICE WAS INSPECTED WITH STRUTS RAISED. THE STENT WAS NOTED TO BE DAMAGED. IT IS NOT KNOWN IF THE DEVICE WAS USED IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074011 ↗
• MalfunctionJul 21, 2022Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% 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 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 STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. IT WAS DETAILED THAT IT WAS DECIDED TO REMOVE BOTH THE STENT/STENT DELIVERY SYSTEM AND THE GUIDEWIRE FROM THE PATIENT. DURING REMOVAL THE STENT ENGAGED/INTERACTED WITH THE CO-PILOT HEMOSTASIS CONTROL VALVE. IT WAS BELIEVED THAT THE INTERACTION WITH THE CO-PILOT CONTRIBUTED TO THE STENT COMING OFF OF THE BALLOON/STENT DELIVERY SYSTEM. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072275 ↗
• MalfunctionFeb 2, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. 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 BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT OF THE SAME SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13421397 ↗
• MalfunctionOct 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY WITH BOTH STENTS. THE DISLODGEMENT OCCURRED WHEN STENTS WERE IN THE NON-MEDTRONIC CATHETER, AND WERE REMOVED WITH THE ENTIRE SYSTEM. THE STENT DELIVERY SYSTEM WAS NEVER INFLATED INSIDE THE PATIENT, THEY BECAME DISLODGED BEFORE INFLATION. THE PHYSICIAN USED A DIFFERENT FLUSH TO HELP NAVIGATING THE STENTS, SINCE IT WAS A TORTUOUS VESSEL, AND IT IS BELIEVED IT MAY HAVE CAUSED THE DISLODGEMENT. NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638333 ↗
• MalfunctionOct 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY WITH BOTH STENTS. THE DISLODGEMENT OCCURRED WHEN STENTS WERE IN THE NON-MEDTRONIC CATHETER, AND WERE REMOVED WITH THE ENTIRE SYSTEM. THE STENT DELIVERY SYSTEM WAS NEVER INFLATED INSIDE THE PATIENT, THEY BECAME DISLODGED BEFORE INFLATION. THE PHYSICIAN USED A DIFFERENT FLUSH TO HELP NAVIGATING THE STENTS, SINCE IT WAS A TORTUOUS VESSEL, AND IT IS BELIEVED IT MAY HAVE CAUSED THE DISLODGEMENT. NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638299 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN A LESION WITH CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE PROXIMAL LAD. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE PATIENT SUFFERED ACUTE STENT THROMBOSIS, 0-24 HOURS POST STENT IMPLANTATION. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11796394 ↗
• InjuryOct 29, 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, SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION IN THE LAD. IT WAS STATED THAT A SMALLER BALLOON WAS PUT THROUGH THE UNDEPLOYED STENT AND POST DILATION WAS SUCCESSFUL AND THE STENT WAS DEPLOYED IN THE PROXIMAL LAD. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10755092 ↗
• MalfunctionOct 13, 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 STENT DISLODGEMENT OCCURRED WHILE ADVANCING THE STENT TO/AT A LESION. THE STENT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10668967 ↗
• MalfunctionAug 28, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. 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 ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT DELIVERY OF THE STENTS WAS NOT POSSIBLE AND UPON REMOVAL OF THE DELIVERY SYSTEM, STRUT DAMAGE WAS EVIDENT TO BOTH STENTS. THE PROCEDURE WAS COMPLETED USING NON-MEDTRONIC STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464287 ↗
• MalfunctionAug 14, 2020Inflation Problem; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Inflation Problem; Activation, Positioning or Separation Problem; 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 LEFT ANTERIOR DESCENDING (LAD) 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED AN ATTEMPT WAS MADE TO DEPLOY THE RESOLUTE ONYX STENT AND THE STENT WAS PARTIALLY DEPLOYED. THE PROXIMAL PORTION OF THE STENTS BALLOON DID NOT INFLATE AND DID NOT FUNCTION AND THE STENT SYSTEM WAS BROUGHT BACK INTO THE GUIDE. THE ENTIRE DELIVERY SYSTEM AND STENT WERE REMOVED FROM THE PATIENT. DURING REMOVAL OF THE DEICES, THE STENT DISLODGED INTO THE PATIENT'S ARM. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10406275 ↗
• MalfunctionAug 7, 2020Activation, Positioning or Separation Problem; Mechanical Jam

  PATIENT'S STATUS POST PERCUTANEOUS CORONARY INTERVENTION (PCI) OF SAPHENOUS VEIN GRAFTS (SVG) TO PATENT DUCTUS ARTERIOSUS (PDA). COMPLICATED BY UNDELPOYED STENT STUCK IN THE SOFT TISSUE IN THE GROIN, NEEDED MANUAL PRESSURE. CROSS OVER ANGIO DID NOT SHOW ANY COMPLICATIONS. HEMATOMA AFTER SITTING UP AND EATING NOW UNDER CONTROL, PRESSURE APPLIED FOR 30 MIN. FEM STOP APPLIED WITH NO PRESSURE, DISTAL PULSES WELL FELT.

  Patient problems: Hematoma

  MAUDE report 10378475 ↗
• MalfunctionAug 7, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A CALCIFIED LESION LOCATED IN THE CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND DAMAGE TO THE STENT OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10377848 ↗
• MalfunctionJul 29, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX RX AND A TELESCOPE GUIDE EXTENSION CATHETER WERE USED DURING A PROCEDURE TO TREAT A MODERATE TORTUOSITY, MODERATE CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE TELESCOPE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUE. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE RESOLUTE ONYX DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES. 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT LIFTED ON THE TELESCOPE ON RAMP DURING ADVANCEMENT. THEY DID TRY TO ADVANCE THE STENT PREVIOUSLY THROUGH A GUIDE ONLY PRIOR TO PUTTING IN TELESCOPE. IT WAS REPORTED THAT THE STENT MAY HAVE BEEN DAMAGED DURING THE FIRST ADVANCEMENT AND NOT NOTICED. THE PROCEDURE WAS COMPLETING USING THE SAME SIZE RESOLUTE ONYX.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338080 ↗
• InjuryJul 29, 2020Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX DES WAS USED DURING A PROCEDURE TO TREAT A NONE TORTUOSITY, NONE CALCIFIED PROXIMAL SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE S TENT BECAME FLARED ON THE PROXIMAL END AND COULDN'T BE DELIVERED, WHEN THEY WENT TO RETRACT THE STENT THEY COULD NOT PULL IT INTO THE GUIDE CATHETER. THE STENT WAS WITHDRAWN TO THE SHEATH BUT WAS UNABLE TO BE REMOVED THROUGH THE SUBCU TISSUE. SURGICAL FORCEPS WAS USED TO REMOVED THE DEVICE THROUGH THE SHEATH CHANNEL. PATIENT SUFFERED SOME POST OPP BLEEDING. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Blood Loss; Injury

  MAUDE report 10338042 ↗
• InjuryMay 6, 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; ONE IN THE GRAFT R-PDA AND THE OTHER IN CX. APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED MYOCARDIAL INFARCTION SECONDARY TO DEMAND ISCHEMIA. STENOSIS WAS FOUND IN THE CX. IT WAS STATED THAT THE MI OCCURRED IN THE LEFT CX WHERE THE INDEX ONYX WAS PLACED. PATIENT WAS TREATED WITH REVASCULARIZATION IN WHICH A NON-MEDTRONIC STENT WAS IMPLANTED IN THE TARGET VESSEL (CX). THE NON-MEDTRONIC STENT WAS PLACED DISTALLY BUT OVERLAPPED THE INDEX DEVICE. PATIENT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10027804 ↗
• InjuryJan 28, 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 RCA, R-PDA AND LAD. THREE EUPHORA PTA BALLOONS WERE ALSO USED IN THESE VESSELS. APPROXIMATELY 2 WEEKS POST PROCEDURE, PATIENT SUFFERED GASTROENTERITIS WITH CHEST PAIN. SAFETY COMMENTED THAT GI BLEED OCCURRED. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9635920 ↗
• DeathJan 27, 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 11 MONTHS POST PROCEDURE, PATIENT DIED. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 9631017 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ((B)(6) 2018), A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA ((B)(6) 2019), ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS ((B)(6) 2019), PATIENT SUFFERED NSTEMI IN THE RCA. EVENT WAS TREATED WITH 2 RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA. SHORTLY AFTER PROCEDURE PATIENT BECAME SHORT OF BREATH, EKG SHOWED STEMI AND WAS TREATED WITH ANOTHER PCI. PATIENT RECOVERED. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9602165 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 9 MONTHS POST FIRST AND SECOND REVASCULARIZATION, DURING A THIRD REVASCULARIZATION, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. IT WAS REPORTED THAT DURING THE REVASCULARIZATION, PATIENT SUFFERED FROM THROMBUS IN THE RCA CAUSING AN ABRUPT CLOSURE OF THE RCA. EVENT WAS SUCCESSFULLY TREATED WITH A MEDTRONIC BMS. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Occlusion; Thrombus

  MAUDE report 9596233 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE PROXIMAL LAD. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO. IT WAS INFORMED THAT THE BROKEN MESH WAS NOTED AFTER STENT INSERTION UPON REMOVAL OF THE DEVICE FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: High Blood Pressure/ Hypertension; Injury; Myocardial Infarction; Nausea; No Consequences Or Impact To Patient; Occlusion

  MAUDE report 9580183 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9435961 ↗
• MalfunctionNov 22, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE STENT SHAFT FRACTURED WHILE ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER. IT WAS ABLE TO BE REMOVED BY REMOVING THE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361240 ↗