Resolute Onyx™ RONYX25018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00643169556812), received between Aug 25, 2017 and Dec 22, 2025 — classified as 5 deaths, 39 injuries, 19 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 63 reports, in the reporter's own words as published by the FDA.

• DeathDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED DURING A PROCEDURE. APPROXIMATELY 4 YEARS LATER THE PATIENT DIED OF HEART FAILURE. IT IS UNKNOWN IF THE STENT WAS OCCLUDED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23862193 ↗
• MalfunctionSep 27, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). AN ANGIOPLASTY WITH A NON-MEDTRONIC (MDT) BALLOON WAS ALSO PERFORMED TO THE 1ST DIAGONAL ARTERY. THREE LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT BEGAN HAVING NEW CHEST PAINS WITH EXERTION AND RELIEVED WITH REST. THREE MONTHS LATER THE PATIENT SAW CARDIOLOGY AND HAD ABNORMAL POSITRON EMISSION TOMOGRAPHY¿COMPUTED TOMOGRAPHY (PET CT) FINDINGS AND WAS BROUGHT IN FOR ANGIOGRAM. THE ANGIOGRAM REVEALED RESTENOSIS IN MID LAD PROXIMAL AND DISTAL TO THE STENT AT INDEX PROCEDURE. IN-STENT RESTENOSIS (ISR) WAS ALSO NOTED IN THE MID RCA. UNDER-EXPANDED STENT WAS ALSO REPORTED. THE RESTENOSIS IN THE LAD WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), INTRAVASCULAR LITHOTRIPSY (IVL), AND STENTING. THE MID RCA ISR WAS TREATED WITH PTCA AND IVL. THE PATIENT WAS REPORTED AS RECOVERING. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE DEVICE AND PROCEDURE. THE SPONSOR ASSESSED THE E

  Patient problems: Chest Pain; Insufficient Information; Stenosis

  MAUDE report 17824010 ↗
• MalfunctionJan 2, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS, IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PREFORMED 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 POSITIONING/ADVANCEMENT. THE STENT COULD NOT PASS THROUGH THE LESION, AND WHEN THE STENT WAS REMOVED IT WAS NOTED THAT THERE WAS A DEFORMATION. A 2.25 X 18MM RESOLUTE ONYX STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082418 ↗
• InjuryDec 22, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT EMBOLIZATION OCCURRED. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Embolism/Embolus; Insufficient Information

  MAUDE report 16032202 ↗
• InjuryOct 25, 2022Difficult to Insert; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem; Difficult to Insert; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80-90% STENOSIS IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN REMOVING THE DEVICE PRIOR TO STENT DEPLOYMENT. IT WAS DETAILED THAT THE STENT WAS UNABLE TO ADVANCED PAST THE FIRST TORTUOUS CURVE IN THE RCA AND WHEN THE STENT DELIVERY SYSTEM WAS BEING PULLED OUT, THE STENT WAS DISLODGED JUST PROXIMAL TO THE FIRST BEND. THE DISLODGED STENT WAS CRUSHED WITH A 2.5MM BALLOON, AND THEN OVERLAPPED WITH 2.5X12MM NON-MEDTRONIC STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15665179 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE SHAFT OF THE DEVICE BROKE WHILE ADVANCING THE DEVICE INTO THE GUIDE CATHETER. THE SHAFT BROKE APPROXIMATELY 6CM DISTAL FROM THE GUIDE CATHETER HUB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15119400 ↗
• MalfunctionMay 31, 2022Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE BALLOON STENT DELIVERY SYSTEM BALLOON BURST/RUPTURED DURING STENT DEPLOYMENT AT THE TARGET LESION. THE STENT AND STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED UNDEPLOYED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547678 ↗
• MalfunctionJun 28, 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. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS REMOVED WITH THE AID OF A TELESCOPE GUIDE EXTENSION CATHETER AND WHOLE SYSTEM WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073811 ↗
• 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 11861656 ↗
• MalfunctionApr 28, 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE LOCATION OF THE DISLODGED STENT WAS NOT POSSIBLE TO DETERMINE, THEREFORE THE UNDEPLOYED STENT WAS NOT ABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736267 ↗
• InjuryApr 27, 2021Burst Container or Vessel; Inflation Problem; Leak/Splash; Burst Container or Vessel; Inflation Problem; Leak/Splash

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS (ONE RONYX25022UX, PLI10 AND ONE RONYX25018UX, PLI20) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING TWO NON-MEDTRONIC WIRES AND TWO NON-MEDTRONIC 2.5X15 BALLOONS. IT WAS STATED THAT PRE-DILATION WAS DIFFICULT DUE TO CALCIUM. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF RONYX25022UX, PLI10. EXCESSIVE FORCE WAS USED DURING DELIVERY OF RONYX25018UX, PLI20. IT WAS REPORTED THAT THE FIRST STENT (RONYX25022UX, PLI10) BALLOON BURST/LEAKED DURING STENT DEPLOYMENT AT 12 ATM FOR 30 SECONDS. IT WAS STATED THAT DURING FIRST INFLATION THE BALLOON DID NOT FULLY INFLATE, THE PROXIMAL END OF THE STENT EXPANDED AND THE STENT CATHETER SYSTEM HAD TO BE PULLED BACK WITH DIFFICULTY. THE STENT WAS DEPLOYED USING TWO NON-MEDTRONIC BALLOONS, A 1.5X15MM AN

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11730556 ↗
• InjuryApr 20, 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 LAD AND RCA. APPROXIMATELY 17 MONTHS LATER THE PATIENT SUFFERED CHEST PAIN, ELEVATED TROPONIN AND MYOCARDIAL INFARCTION THAT WAS DIAGNOSED AS EXACERBATION OF HEART FAILURE. EVENT TREATED WITH HOSPITALIZATION AND MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THAT THE PATIENT SUFFERED MI OF UNKNOWN VESSEL.

  Patient problems: Myocardial Infarction

  MAUDE report 11692431 ↗
• MalfunctionMar 30, 2021Leak/Splash; Activation, Positioning or Separation Problem; Leak/Splash; 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 MODERATELY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THE BALLOON LEAKED DURING STENT DEPLOYMENT RESULTING IN INADEQUATE VESSEL WALL APPOSITION. AN ADDITIONAL BALLOON WAS USED TO POST DILATE THE STENT TO GET OPTIMAL ARTERIAL WALL APPOSITION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587563 ↗
• MalfunctionMar 29, 2021Inadequacy of Device Shape and/or Size

  MEDTRONIC RESOLUTE ONYX ZOTAROLIMUS ELUTING STENT TOO SMALL FOR LESION, LONGER STENT CHOSEN.

  Patient problems: Insufficient Information

  MAUDE report 11580943 ↗
• InjuryMar 19, 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 1ST OBTUSE MARGINAL. APPROXIMATELY 20 MONTHS POST PROCEDURE THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA RELATED TO COVID-19 AND DURING HOSPITALIZATION SUFFERED MYOCARDIAL INFARCTION IN A UNKNOWN VESSEL. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Myocardial Infarction; Pneumonia

  MAUDE report 11527098 ↗
• MalfunctionJan 7, 2021Material 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, SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT THE STENT WENT IN AND OUT MULTIPLE TIMES AND THE STENT GOT CAUGHT ON A PREVIOUSLY DEPLOYED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131108 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED: THREE IN THE LAD AND ONE IN THE 1ST DIAGONAL. APPROXIMATELY 10 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO BILATERAL PNEUMONIA AND ONGOING SEPSIS. THE EVENT WAS TREATED WITH MEDICATION BUT THE PATIENT DIED APPROXIMATELY 5 DAYS LATER. ACUTE RESPIRATORY DISTRESS SYNDROME WAS THE PRIMARY CAUSE OF DEATH AND WAS ASSESSED AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION BY THE INVESTIGATOR AND SPONSOR. THE DEATH WAS CLASSIFIED AS A NON-CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE SEPSIS AS NOT RELATED TO STUDY DEVICE OR ANTI PLATELET MEDICATION AND THE SPONSOR ASSESSED IT AS UNLIKELY RELATED TO STUDY DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Pneumonia

  MAUDE report 10990337 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99.9% STENOSIS LOCATED IN THE MID AND MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT OF A SMALLER SIZE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975031 ↗
• 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 10873972 ↗
• 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 10475625 ↗
• 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. 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 9847402 ↗
• InjuryMar 4, 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 LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM GI BLEED . EVENT WAS TREATED WITH BLOOD TRANSFUSION. PATIENT WAS NOT ON DAPT 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT PROBABLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 9785957 ↗
• InjuryMar 2, 2020Adverse 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 IMPLANTED IN THE OBTUSE MARGINAL. APPROX 17 MONTHS LATER THE PATIENT SUFFERED NON-STEMI (NON TARGET VESSEL). ANGIO REVEALED 70-80% STENOSIS OF LAD. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE MEDICATION. REVASCULARIZATION WAS CARRIED OUT TO TREAT THE LAD (NON-TVR). THE PATIENT RECOVERED. CEC ADJUDICATED NON-Q-WAVE MI OF TARGET VESSEL, MEDTRONIC EXTENDED HISTORICAL SPONTANEOUS IN THE LAD. CEC ADJUDICATED THAT LATE STENT THROMBOSIS ARC DEFINITE WAS NOTED.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9773582 ↗
• InjuryFeb 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 N THE R-PDA. ONE RESOLUTE ONYX DES WAS INTRODUCED INTO THE GUIDE CATHETER BUT NOT IMPLANTED. APPROXIMATELY 9 MONTHS POST PROCEDURE, PATIENT SUFFERED DEMAND ISCHEMIA. PATIENT IS RECOVERING. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9719724 ↗
• MalfunctionFeb 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 MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED 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 AFTER REMOVAL FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706155 ↗