Resolute Onyx™ RONYX25022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00643169556829), received between Jul 28, 2017 and Jan 12, 2024 — classified as 3 deaths, 37 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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.

• InjuryJan 12, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 99% STENOSIS IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THERE WERE ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT WAS STATED THAT THE PROXIMAL END OF THE BALLOON SEEMED ENLARGED AS THOUGH IT HAD GOTTEN CAUGHT ON SOMETHING OR WASN'T CRIMPED DOWN. THE DEVICE WAS INSPECTED. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS BALLOONED UP AGAINST THE WALL WITH ANOTHER STENT. THE DISLODGED STENT COVERED THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THEREFORE A WIRE HAD TO BE PASSED THROUGH THE UNDEPLOYED STENT AND DEPLOYED STENT, AND THERE WAS A NEED TO BALLOON AND THEN STENT THE LAD. THE END RESULT WAS GOOD. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 18501289 ↗
• MalfunctionSep 21, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT THE STENT WAS INSERTED INTO THE PATIENT BUT IT WOULD NOT CROSS THE LESION. THE DEVICE WAS THEN REMOVED AND THE LESION WAS PRE-DILATED WITH A BALLOON. UPON REINSERTING THE STENT, THE STENT WAS NOTICED TO BE DAMAGED ON THE CATHETER AND WOULD NOT ADVANCE. THE DEVICE WAS NOT NOTED TO BE DAMAGED DURING PREP OR PRIOR TO INSERTION ON THE FIRST ATTEMPT. THE STENT WAS DAMAGED UPON REINSERTION ON THE SECOND ATTEMPT BUT NEVER MADE IT INTO THE BODY. THE DAMAGED DEVICE WAS NOT ABLE TO BE USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460934 ↗
• InjuryJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE SPRINTER LEGEND BALLOON CATHETER WERE ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 75% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX BUT EXCESSIVE FORCE WAS NOT USED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE SPRINTER LEGEND AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED, IT WAS CRUSHED AGAINST THE VESSEL WALL. IT WAS STATED THAT AFTER THE STENT DISLODGED THERE WERE MULTIPLE STENTS AND BALLOONS USED AS THE VESSEL HAD DISSECTED.  IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES OCCURRED WITH THE SPRINTER LEGEND DEVICE FOLLOWING BALLOON INFLATION. THERE WAS AN ISSUE REMOVING THE BALLOON FROM THE CATHETER AS IT WAS TIGHT. THE PHYSICIAN INDICATED THAT THE CO-PILOT CLAMPED DOWN ON THE SPRINTER LEGEND AND STRETCHED THE CATHETER.  NO FURTHER PAT

  Patient problems: Vascular Dissection

  MAUDE report 13277911 ↗
• InjuryJul 23, 2021Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. 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 WHILE THE STENT WAS BEING ADVANCED DOWN THE ARTERY, RESISTANCE WAS FELT. THE STENT WOULD NOT CROSS THE CALCIFIED LESION AND WAS REMOVED. UPON REMOVAL OF THE STENT, IT WAS NOTICED THAT ONE OF THE STENT STRUTS HAD LIFTED OFF OF THE DELIVERY BALLOON. A 2.5X18MM ONYX STENT WAS THEN DELIVERED AND SUCCESSFULLY TREATED THE LESION. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 12216213 ↗
• InjuryJul 2, 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 RCA. DURING A REVASCULARIZATION PROCEDURE APPROXIMATELY 2 MONTHS LATER, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE AND 18 MONTHS POST REVASCULARIZATION THE PATIENT SUFFERED FROM TARGET LESION STENT THROMBOSIS AND 100% OCCLUSION OF THE RCA. THE EVENT WAS TREATED WITH REVASCULARIZATION AND MEDICATION. THE PATIENT IS REPORTED TO HAVE RECOVERED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 12107485 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A LESION. THE SHEATH WAS REMOVED PER IFU. IT WAS FURTHER REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS REPORTED THAT STENT STRUTS WERE LIFTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964724 ↗
• InjuryMay 17, 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. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE AND APPROXIMATELY 17 MONTHS POST REVASCULARIZATION, CEC ADJUDICATED A TARGET VESSEL MYOCARDIAL INFARCTION OCCURRED INVOLVING THE RCA.

  Patient problems: Myocardial Infarction

  MAUDE report 11830676 ↗
• InjuryApr 27, 2021Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove; Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove

  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 11730553 ↗
• 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 11692447 ↗
• InjuryMar 10, 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE PROXIMAL, DISTAL AND 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING THE FAILED DELIVERY. IT WAS STATED THAT SPONTANEOUS CORONARY ARTERY DISSECTION OCCURRED IN THE RCA AND BY-PASS SURGERY WAS REQUIRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Unspecified Tissue Injury; Vascular Dissection

  MAUDE report 11453777 ↗
• InjuryDec 18, 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 1ST DIAGONAL AND ONE IN THE RAMUS. APPROXIMATELY 19 MONTHS POST PROCEDURE THE PATIENT SUFFERED ACUTE ON CHRONIC CONGESTIVE HEART FAILURE WHICH WAS TREATED WITH SALT AND FLUID RESTRICTION, AND DIURESIS. THE INVESTIGATOR AND SPONSOR ASSESSED THE HEART FAILURE AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. DIAGNOSTIC TESTS ALSO SHOWED CORONARY CALCIFICATION WITH CHRONICALLY OCCLUDED 1ST DIAGONAL. TARGET LESION PCI BALLOON ANGIOGRAPHY WAS CARRIED OUT TO TREAT 100% IN- STENT RESTENOSIS OF THE 1ST DIAGONAL. THE INVESTIGATOR AND SPONSOR ASSESSED THE CAD AND OCCLUSION AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11037182 ↗
• MalfunctionNov 30, 2020Activation, Positioning or Separation Problem; Device Damaged by Another Device; Material Deformation; Activation, Positioning or Separation Problem; Device Damaged by Another Device; 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 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT TWO WEEKS AFTER THE RESOLUTE ONYX STENT WAS IMPLANTED THE PATIENT WAS BROUGHT BACK TO TRY A NEW STRATEGY AS DURING THE FIRST PROCEDURE DIFFICULTY ADVANCING OTHER DEVICES OCCURRED E.G. GUIDELINES/BALLOONS AND IT WAS ONLY POSSIBLE TO STENT THE PROXIMAL SECTION. A NON-MEDTRONIC STENT SYSTEM WAS IMPLANTED INSIDE THE RESOLUTE ONYX STENT AND THE RESOLUTE ONYX STENT BECAME DAMAGED. IT WAS STATED THAT THE ORIGINAL RESOLUTE ONYX STENT MAY HAVE BEEN COMPROMISED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10917535 ↗
• InjuryOct 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 2.5 X 22 MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED OSTIUM - PROXIMAL LEFT MAIN (LM), CIRCUMFLEX (CX), OBTUSE MARGINAL (OM). THE PROXIMAL CX EXHIBITED 90% STENOSIS AND THE DISTAL CX/OM EXHIBITED 80% STENOSIS. IT WAS STATED THAT THE PATIENT HAD A VERY ACUTE TAKE OFF OF LCX ARTERY FROM THE LMCA. A 6F GUIDELINER DEVICE WAS ALSO USED, AND IT REMAINED IN THE 6F EBU 3.75 GUIDE CATHETER. THE RESOLUTE ONYX DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING 2.0 MM AND 2.5 MM COMPLIANT BALLOONS. IT WAS STATED THAT A 2.5 X 38 MM STENT WAS ATTEMPTED FIRST BUT DUE TO TORTUOSITY THE 2.5X22 WAS THEN USED. 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 PROXIMAL CX LESION AND STENT DISLODGEMENT OCCURRED WHEN REMOVING THE DEVICE. NO SIGNIFICANT RESISTANCE OR FORCE WAS REQUIRED TO WITHDRAW THE STENT. THE STENT WAS LEFT UNDEPLOYED IN THE LEFT MAIN EXTENDING INTO THE PROXIMAL CX. DUE TO THE LOCATIO

  Patient problems: Injury; Insufficient Information

  MAUDE report 10641785 ↗
• DeathSep 7, 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. ONE IN THE RCA AND THE OTHER IN THE LCX. APPROXIMATELY 15 MONTHS POST PROCEDURE, PATIENT EXPIRED. DEATH CLASSIFICATION IS UNKNOWN. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death; Insufficient Information; Respiratory Failure

  MAUDE report 10498958 ↗
• InjuryMay 1, 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. APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CHEST PAIN. EVENT WAS CLASSIFIED AS MYOCARDIAL INFARCTION INVOLVING THE TARGET VESSEL (LAD). EVENT WAS TREATED WITH LEFT HEART CATHETERIZATION AND LEFT IN THE HOSPITAL FOR 'WASHOUT' OF ANTICOAGULANT THERAPY PRIOR TO BYPASS SURGERY (2 VESSEL). INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO INDEX DEVICE. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION PATIENT IS RECOVERING.

  Patient problems: Myocardial Infarction

  MAUDE report 10016916 ↗
• InjuryFeb 27, 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 DURING DELIVERY TO A LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 9762432 ↗
• 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 RCA. APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CANCER AND DIED 10 MONTHS POST INDEX PROCEDURE. DEATH CLASSIFICATION IS UNKNOWN. DEATH TOOK PLACE AFTER PATIENT'S STUDY EXIT. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9675925 ↗
• MalfunctionDec 18, 2019Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL CX ARTERY. 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS STATED THAT WHEN ATTEMPTING TO POSITION THE DEVICE RESISTANCE WAS MET WHILE TRYING TO ADVANCE AROUND TORTUOSITY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. A TELESCOPE 6F GUIDE EXTENSION CATHETER WAS ALSO USED DURING THE PROCEDURE. IT WAS ALSO STATED THAT RESISTANCE WAS ENCOUNTERED WHEN WITHDRAWING THE DEVICE BACK INTO THE TELESCOPE CATHETER. THE TELESCOPE AND THE RESOLUTE ONYX WERE REMOVED SIMULTANEOUSLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488831 ↗
• MalfunctionNov 15, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT WAS DAMAGED WHILE TRYING TO CROSS THE LESION. ANOTHER 2.5 X 18MM RESOLUTE ONYX WAS USED TO TREAT THE LESION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325899 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 8 MONTH POST PROCEDURE, PATIENT SUFFERED IN STENT RESTENOSIS, REPORTED TO BE RELATED TO STENT THROMBOSIS IN THE TARGET VESSEL WHICH WAS TREATED WITH CABG. PATIENT IS RECOVERING. INVESTIGATOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Thrombus

  MAUDE report 9155207 ↗
• MalfunctionAug 19, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A NARROW, CONCENTRIC CALCIFIED LESION. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS AND THAT ON REMOVAL, STENT STRUTS WERE LIFTED. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8905358 ↗
• MalfunctionAug 16, 2019Difficult to Remove; Material Deformation; Difficult to Remove; 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 OBTUSE MARGINAL (OM). 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS REPORTED THAT WHILE ATTEMPTING TO DIRECT STENT RESISTANCE WAS ENCOUNTERED AT THE LESION SITE SO THE DEVICE WAS REMOVED SO THAT THE LESION COULD BE DILATED. IT WAS NOTED THAT THERE WAS ALSO RESISTANCE TAKING THE STENT BACK INTO THE GUIDE. THE STENT WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED USING A 2.5 X 18 MM NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901093 ↗
• MalfunctionAug 6, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOSITY, MILDLY CALCIFIED LESION EXHIBITING 80% STENOSIS WITH A TIGHT CURVE IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. 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 DURING DELIVERY. IT WAS REPORTED THAT THE STENT COULD NOT BE DELIVERED TO THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT ONE OF THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED USING A RESOLUTE ONYX 2.5 X 22MM DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864637 ↗
• InjuryJul 31, 2019Adverse 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 1ST DIAGONAL AND ONE INTO THE LAD. DURING A STAGED PROCEDURE FOUR RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. APPROX 5 MONTHS POST STAGED PROCEDURE THE PATIENT SUFFERED NSTEMI OF THE RCA AND TOTAL OCCLUSION OF THE RCA. THE PATIENT RECEIVED A LEFT HEART CATH AND WAS TREATED WITH MEDICATION. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 8844910 ↗
• DeathApr 29, 2019Adverse 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 LCMA. APPROX. 6 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH FOUND TO BE CAUSED BY ASPIRATION PNEUMONIA. THE PATIENT DIED 4 DAYS LATER. THE PATIENT WAS NOT TAKING DUAL ANTI-PLATELET THERAPY WITHIN 24 HOURS OF THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION. CEC ADJUDICATED DEATH AS A CARDIAC DEATH.

  Patient problems: Death

  MAUDE report 8560647 ↗