Resolute Onyx™ RONYX25015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00643169556805), received between Aug 3, 2017 and Dec 22, 2022 — classified as 5 deaths, 46 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 67 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS DETAILED THAT THE STENT WAS MEANT TO BE DEPLOYED IN THE MID CX, HOWEVER, THE STENT BECAME STUCK IN THE CX. A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS INSERTED INTO THE TORTUOUS VESSEL, AND THE STENT WAS INSERTED THROUGH THE GEC. IT IS BELIEVED THAT THE NON-MEDTRONIC GEC CAUSED THE STENT TO BE DISLODGED. THE STENT WAS FOUND IN THE PROXIMAL CIRCUMFLEX AND IT WAS DEPLOYED IN THAT LOCATION WITH A BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16032561 ↗
• InjuryJun 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON. IT WAS STATED THAT THE STENT WAS UNABLE TO BE RETRIEVED DESPITE MULTIPLE ATTEMPTS AND ASSISTANCE FROM THE INTERVENTIONAL RADIOLOGY. THE LOCATION WAS NOT IDEAL FOR DEPLOYMENT AND IT COULD NOT BE ADVANCED FURTHER. IT WAS STATED THAT THE UNEMPLOYED STENT WAS LOCATED IN THE PROXIMAL CIRCUMFLEX EXTENDING INTO THE LEFT MAIN. THE PATIENT WAS TRANSFERRED TO A HIGH LEVEL OF CARE TO REMOVE THE STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14730089 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED FOUR MONTHS AGO TO TREAT A LESION. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING ECZEMA SINCE THE STENT WAS IMPLANTED. THE PATIENT IS GOING TO WORK WITH THEIR ALLERGIST TO TRY AND DETERMINE IF THERE IS A POSSIBLE ALLERGIC REACTION TO THE STENT MATERIALS. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 14642857 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED HEPARIN INDUCED THROMBOCYTOPENIA AND THROMBOSIS POST STENT IMPLANTATION. PATIENT IS CURRENTLY IN HOSPITAL.

  Patient problems: Coagulation Disorder; Thrombosis/Thrombus

  MAUDE report 13839130 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE DISTAL RCA. A RADIAL APPROACH WAS USED. THE DEVICE WAS INSPECTED BEFORE USE, WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE WIRE AND WOULD NOT ADVANCE OR PULL BACK. THE DEVICE GOT STUCK WHILE INSIDE THE GUIDE CATHETER, AROUND THE SHOULDER AREA AND DID NOT REACH THE CORONARY ARTERY. RESISTANCE WAS NOTED UPON WITHDRAWING THE STENT CATHETER AND IT WAS NOT POSSIBLE TO REMOVE THE DEVICE WITHOUT ALSO REMOVING THE INTERVENTIONAL WIRE. EXCESSIVE FORCE WAS NOT USED DURING REMOVAL OF THE DEVICE. IT WAS LATER REPORTED THAT A DETACHMENT OF THE INNER MEMBER AT THE EXCHANGE JOINT OCCURRED DURING ADVANCEMENT OF THE DEVICE TO THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506946 ↗
• MalfunctionNov 10, 2021Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO IMPLANT AN RESOLUTE ONYX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE STENT WAS EXPIRED WHEN IT WAS IMPLANTED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787232 ↗
• InjuryMay 5, 2021Adverse 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 IN THE LAD. CEC ADJUDICATED A STROKE HAS OCCURRED.

  Patient problems: Stroke/CVA

  MAUDE report 11775583 ↗
• InjuryApr 22, 2021Adverse 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 IN THE RCA. APPROXIMATELY 13 MONTHS POST PROCEDURE PATIENT SUFFERED OF SYSTEMATIC INFLAMMATORY RESPONSE SYNDROME, PNEUMONIA DUE TO UNSPECIFIED INFECTIOUS ORGANISM AND DIED. THE EVENT WAS TREATED WITH CHEST TUBE, MEDICATION AND PALLIATIVE CARE. DEATH WAS CLASSIFIED AS NON-CARDIAC DEATH.

  Patient problems: Pneumonia

  MAUDE report 11705485 ↗
• MalfunctionMar 29, 2021Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  DURING A PROCEDURE, AN ATTEMPT AS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 THE STENTS BALLOON BURST ON THE FIRST INFLATION, DURING STENT DEPLOYMENT AT 12ATMS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580689 ↗
• 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 11552173 ↗
• MalfunctionMar 10, 2021Device 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 ELUTING STENT TO TREAT A CALCIFIED LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE TO THE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED. IT WAS REPORTED THAT THE DEVICE DID NOT CROSS THE LESION. IT WAS STATED THAT ON REMOVAL FROM THE PATIENT'S BODY A DAMAGED STRUT ON THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETE USING TWO RESOLUTE ONYX STENTS, ONE 225X12MM AND ONE 25X18MM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453534 ↗
• MalfunctionDec 21, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE DISTAL 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT ANOTHER STENT OF THE SAME SIZE WAS USED WITH NO ISSUES NOTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11045295 ↗
• InjuryDec 11, 2020Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE RESOLUTE ONYX DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT UPON REMOVAL OF THE STENT INTO THE TELESCOPE IT WAS NOT CO AXIAL. IT WAS STATED THAT THE TELESCOPE CAUGHT ON THE STENT AND STARTED TO DISLODGE THE STENT. THE STENT WAS EXPANDED WHERE IT WAS IN THE PROXIMAL LAD AND WAS NOT REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10990394 ↗
• InjuryDec 9, 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 IMPLANTED IN THE LAD. A DISSECTION OCCURRED DURING PROCEDURE. APPROXIMATELY 19 MONTHS POST PROCEDURE, PATIENT SUFFERED GASTROINTESTINAL BLEED AND WAS HOSPITALIZED. PATIENT WAS ON DAPT WITHIN 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED EVENT AS NOT RELATED TO THE STUDY DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO STUDY DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10980143 ↗
• InjuryNov 20, 2020Adverse 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; ONE IN THE L-PDA AND ONE IN THE CIRCUMFLEX. TWO RESOLUTE ONYX DES WERE IMPLANTED DURING A REVASC PROCEDURE, ONE IN THE CX AND ONE IN THE OM. APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CHEST DISCOMFORT WITH EXERTION. PATIENT WAS HOSPITALIZED AND PTCA WITH BRACHYTHERAPY OF THE CX CARRIED OUT. A NON-MEDTRONIC BALLOON WAS USED. PATIENT RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. STENT THROMBOSIS IN THE CIRCUMFLEX (CASS #19) WAS CONFIRMED BY ANGIO. EVENT WAS TREATED WITH POBA. CEC ADJUDICATED THE EVENT AS TLR PERCUTANEOUS INTERVENTION OF THE CX.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10873988 ↗
• MalfunctionOct 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A MODERATE TORTUOUS, MODERATE CALCIFIED LESION IN THE MID CIRCUMFLEX (CM) ARTERY. THERE WAS NO DAMAGE NOTED REMOVING THE DEVICE FROM THE HOOP. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. THE PHYSICIAN WAS UNABLE TO REMOVED THE DISLODGED STENT. THE STENT WAS DEPLOYED PROXIMAL TO THE MID CIRCUMFLEX LESION. THE MID LESION WAS ALSO STENTED. THE PATIENT IS DOING FINE AND WAS NOT INJURED DURING THE EVENT.

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

  MAUDE report 10625286 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE THREE RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENTS WERE IMPLANTED IN THE PROX RCA, OB MARG AND THE DISTAL CX. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A FEW EPISODES OF BLOODY STOOLS AND STRAINED TO PASS STOOLS. DAPT WAS TAKEN WITHIN 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE. THE PATIENT IS RECOVERING/RESOLVING.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10475656 ↗
• MalfunctionJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL CX. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT CAME OFF THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349620 ↗
• MalfunctionJun 22, 2020Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID 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 STENT DEFORMATION OCCURRED IN VIVO DURING ADVANCEMENT / POSITIONING. IT WAS STATED THAT THE TWO RESOLUTE ONYX STENTS FAILED TO CROSS THE LESION. THE STENTS WERE REMOVED FROM THE PATIENT AND INSPECTED. UPON INSPECTION THE STENT STRUTS IN THE MID PORTION WERE NOTED TO BE RAISED AND FRACTURED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10177917 ↗
• InjuryMar 10, 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 EXHIBITING 99% STENOSIS LOCATED IN THE DISTAL 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THEY ATTEMPTED TO RECROSS THE DISLODGED STENT TO CRUSH IT AGAINST THE VESSEL WALL BUT WAS UNABLE TO DO SO. IT WAS REPORTED THAT THE STENT WAS NOT REMOVED AND THE PATIENT WAS GOING TO OPEN HEART SURGERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY - CHEST PAIN.

  Patient problems: Chest Pain; Injury

  MAUDE report 9810455 ↗
• DeathFeb 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 RCA. APPROXIMATELY 11 MONTHS POST PROCEDURE, PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. IT WAS STATED THAT PATIENT WAS NOT TAKING THE MEDICATION REGULARLY AND USING THE NEBULIZER MORE FREQUENTLY THAN RECOMMENDED WHICH COULD HAVE LED TO CARDIAC ARREST. IT WAS ALSO REPORTED THAT PATIENT STILL HEAVILY SMOKED CIGARETTES WHICH LIKELY CONTRIBUTED TO PATIENT'S DEATH. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELETS MEDICATION AND UNLIKELY RELATED TO INDEX DEVICE. CEC ADJUDICATED THE DEATH AS A CARDIAC DEATH. CEC COMMENTED POSSIBLE STENT THROMBOSIS, SUDDEN DEATH 1 YR POST STENT. THE POSSIBLE STENT THROMBOSIS OCCURRED IN THE RCA.

  Patient problems: Death

  MAUDE report 9762225 ↗
• DeathFeb 6, 2020Adverse 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 CIRCUMFLEX. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CARDIOPULMONARY ARREST. MEDICATION WAS GIVEN. PATIENT DIED ON THE SAME DAY. 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 AND ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9675450 ↗
• 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 CIRCUMFLEX. APPROX 12 MONTHS POST INDEX PROCEDURE AND STAGED PROCEDURE, THE PATIENT SUFFERED A NON CARDIAC CHEST PAIN. THE PATIENT WAS TREATED WITH MEDICATION. CEC ADJUDICATED THE EVENT AS NON-Q-WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS. 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 RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9663997 ↗
• InjuryFeb 4, 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 LAD. APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ACUTE CEREBROVASCULAR ACCIDENT (STROKE). PATIENT'S MEDICATION WAS ADJUSTED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE AND UNLIKELY RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE AND POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Stroke/CVA

  MAUDE report 9663982 ↗
• InjuryFeb 3, 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: ONE INTO THE L-PDA AND ONE INTO THE CX. DURING A REVASCULARIZATION PROCEDURE TWO RESOLUTE ONYX WERE IMPLANTED IN THE CX AND OM3. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE AND 6 MONTHS POST REVSACULARIZATION PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION . EVENT WAS TREATED WITH POBA IN THE CX. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9659710 ↗