Resolute Onyx™ RONYX30015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00643169556980), received between Feb 23, 2018 and Jul 31, 2023 — classified as 3 deaths, 50 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (24 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT DISLODGED PROXIMALLY ONTO THE CATHETER AT THE TIME OF DEPLOYMENT. THE BALLOON WAS INFLATED AND IT WAS NOTED THAT THE STENT WAS NOT THERE. THE STENT DISLODGED ONTO THE CATHETER, THEREFORE, NO EQUIPMENT WAS REQUIRED TO RETRIEVE THE DISLODGED STENT. THE DISLODGED STENT WAS REMOVED. THE EVENT OCCURRED POST TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), AND IT WAS DIFFICULT TO ENGAGE THE LEFT MAIN (LM). THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424153 ↗
• MalfunctionJan 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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/AT LESION. THE DISLODGED STENT WAS NOT REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252135 ↗
• MalfunctionJun 30, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS NOT REMOVED AND WAS DEPLOYED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14874919 ↗
• InjuryMay 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX 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 LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. 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 14520767 ↗
• InjuryMay 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX 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 LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. 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 14520765 ↗
• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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. THE PROCEDURE WAS COMPLETED USING TWO OTHER RESOLUTE ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447738 ↗
• InjuryMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT IN A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE OSTIUM OF THE CIRCUMFLEX (CX) ARTERY. THERE WAS A 90 DEGREE TAKE OFF OF THE OSTIAL LESION. 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 WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO OPERATING ROOM AT THE LESION. THE STENT WAS REMOVED FROM THE PATIENT USING A NON-MDT BALLOON. THE NON-MDT BALLOON WAS THREADED THROUGH THE STENT, INFLATED TO 3ATM AND THIS SECURED THE STENT. THE STENT WAS PULLED OUT OF THE GUIDE AND BROUGHT OUTSIDE OF THE BODY. THIS WAS REPORTED AS EASY TO COMPLETE. ADDITIONAL BALLOON PREP WAS CARRIED OUT WITH A 2.5X12MM BALLOON. A NEW STENT WAS DELIVERED WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14352023 ↗
• MalfunctionApr 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A STEMI PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT DISLODGED AND GOT LOST IN THE DESCENDING THORACIC AORTA. NO INTERVENTION WAS CARRIED OUT AND THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14082765 ↗
• InjuryApr 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE PROXIMAL OF THE CIRCUMFLEX (CX) ARTERY. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE STENT WAS NEGATIVELY PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 3.0X12MM BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. THE TELESCOPE WAS THEN USED FOR EXTRA SUPPORT BUT THE STENT WAS STILL UNSUCCESSFUL. STENT DISLODGEMENT OCCURRED WHEN REMOVING THE STENT BACK INTO THE TELESCOPE TIP. THE PHYSICIAN INITIALLY TRIED TO USE THE STENT BALLOON TO REMOVE THE DISLODGED STENT BUT THIS WAS UNSUCCESSFUL. A 1.5MM BALLOON WAS THEN DILATED INSIDE THE DISLODGED STENT AND THE DISLODGED STENT WAS SUCCESSFULLY PULLED BACK INTO THE NON-MEDTRONIC GUIDE CATHETER AND REMOVED

  Patient problems: Insufficient Information

  MAUDE report 14019441 ↗
• InjuryJan 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED USING A 1.5MM BALLOON. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13356982 ↗
• MalfunctionJan 6, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH AN NC BALLOON. THE LESION WAS ALSO TREATED WITH A NON MEDTRONIC INTRAVASCULAR LITHOTRIPSY (IVL). 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 IN VIVO. A NON-MEDTRONIC EXTENSION CATHETER WAS PLACED PR OXIMAL TO THE LESION AND THE STENT WAS ADVANCED. IT WAS STATED THAT THE STENT COULD NOT CROSS THE LESION DUE LESION TORTUOSITY AND CALCIFICATION. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE AND WHEN IT WAS BEING PULLED BACK THROUGH THE EXTENSION CATHETER, THE STENT STRUTS WERE LIFTED OFF FROM THE BALLOON. THE DELIVERY SYSTEM WAS REMOVED AND A NEW NON-MEDTRONIC EXTENSION CATHETER WAS USED TO DEPLOY ANOTHER RESOLUTE ONYX SUCCESSFULLY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174103 ↗
• InjuryMar 30, 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 CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND CIRCUMFLEX (CX) 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 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 DIFFICULTY ENGAGING THE GUIDE IN THE RCA OCCURRED AND AFTER ATTEMPTING TO ADVANCE THE STENT, THEY PULLED BACK AND THE STENT WAS NO LONGER ON THE CATHETER. THE DISLODGED STENT WAS IN THE AORTA AND ENDED UP IN THE LEFT CX ARTERY. IT WAS STATED THAT THE DISLODGED STENT WAS NOT REMOVED AND WAS CRUSHED TO THE VESSEL WALL WITH A NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11587392 ↗
• InjuryDec 1, 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 IN THE LAD. FOLLOWING DAY, DURING A STAGED PROCEDURE, A RESOLUTE ONYX WAS ALSO IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED CHEST PAIN - ACUTE CORONARY SYNDROME AND REVACULARIZATION OF THE TARGET VESSELS. TWO STENTS WERE IMPLANTED; ONE IN THE LAD AND THE OTHER IN THE CX. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF TARGET VESSEL 3RD UDMI SPONTANEOUS AND REVASCULARIZATION IS NOT AN EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 10927286 ↗
• InjuryNov 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 LAD. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MELENA. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT IS NOT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10905231 ↗
• InjuryNov 24, 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 LCMA. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (VESSEL UNKNOWN) . EVENT WAS TREATED WITH MEDICATION AND CARDIAC CATH. 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 IS RECOVERING.

  Patient problems: Myocardial Infarction

  MAUDE report 10894678 ↗
• InjuryNov 23, 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. AT THE INDEX PROCEDURE, PATIENT SUFFERED FROM SIDE BRANCH OCCLUSION (1ST DIAGONAL). INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 10884706 ↗
• DeathNov 3, 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 IN THE LAD. APPROXIMATELY 14 MONTHS POST PROCEDURE, PATIENT SUFFERED WORSENING OF CONGESTIVE HEART FAILURE AND DIED. DEATH IS CLASSIFIED A NON-SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED EVENT AS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10776732 ↗
• InjuryOct 14, 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. ONE RESOLUTE ONYX DES WAS ALSO IMPLANTED IN THE 1ST OBTUSE MARGINAL DURING A STAGED PROCEDURE. APPROXIMATELY 14 MONTHS LATER THE PATIENT SUFFERED RECTAL BLEEDING. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND NOT RELATED TO THE DEVICE.

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

  MAUDE report 10676573 ↗
• InjuryOct 5, 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 IN THE LAD AND AN EUPHORA PTA BALLOON WAS ALSO USED DURING PROCEDURE. SAME DAY PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. PATIENT RECOVERED. CEC ADJUDICATED NON-Q WAVE MI OF THE TARGET VESSEL LAD MEDTRONIC EXTENDED HISTORICAL PERI-PCI AND SCAI DEFINITION PERI-PCI. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE AND ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10625330 ↗
• MalfunctionAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A NONE TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OM). THERE WAS NO ISSUE REMOVING THE DEVICE FROM THE 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. IT WAS REPORTED THAT GREATER THAN 24 HOURS AND LESS THAN 30 DAYS POST IMPLANTATION THE PATIENT SUFFERED STENT THROMBUS. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Thrombus

  MAUDE report 10471262 ↗
• MalfunctionAug 24, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  TWO RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WERE USED DURING A PROCEDURE TO TREAT A SEVERELY CALCIFIED, MODERATE TORTUOSITY DISTAL CIRCUMFLEX (CX) ARTERY. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT BOTH STENTS FAILED TO CROSS THE LESIONS AND THE STENTS BECAME DISLODGED. BOTH STENTS WERE CRUSHED AGAINST THE ARTERIAL WALL. THE PATIENT IS STABLE AND ALIVE WITH NO OTHER COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 10441329 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE TWO RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 14 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED ACUTE ISCHEMIC STROKE. EVENT TREATED WITH MEDICATION AND HOSPITALIZATION. PATIENT HAS NOT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTIPLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 10337110 ↗
• MalfunctionJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS. THE 3.00 X 15MM ONYX WAS USED TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID LAD WITH 80% STENOSIS. THE 3.5 X 22MM ONYX WAS USED TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE MID LEFT MAIN EXHIBITING 50% STENOSIS. THE 3.00 X 15MM ONYX 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. IT WAS REPORTED THAT THE 3.00 X 15MM ONYX DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT IS REPORTED THAT THE STENT DISLODGED OUTSIDE OF THE PATIENT, IT WAS ON THE WIRE OUTSIDE OF THE GUIDE CATHETER. THE 3.0 X 15 ONYX STENT WAS COMPLETELY OFF THE STENT DELIVERY BALLOON, BUT STILL ON THE PTCA WIRE OUTSIDE THE BODY. THE 3.5 X 22MM ONYX WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263413 ↗
• DeathMar 19, 2020Adverse 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. A EUPHORIA BALLOON CATHETER WAS ALSO USED. APPROXIMATELY 7 MONTHS LATER THE PATIENT SUFFERED HOSPITAL ACQUIRED PNEUMONIA TREATED WITH HOSPITALIZATION AND EPINEPHRINE AND A CHEST TUBE. THE PATIENT DIED. CAUSE OF DEATH WAS CARDIAC ARREST. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Death; Pneumonia

  MAUDE report 9852402 ↗
• MalfunctionFeb 19, 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 THAT THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; No Known Impact Or Consequence To Patient

  MAUDE report 9726881 ↗