Resolute Onyx™ RONYX30026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00643169557017), received between Jun 29, 2017 and May 20, 2022 — classified as 6 deaths, 24 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (22 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  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 OSTIUM OF THE 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT THIS WAS NOT A DEVICE ISSUE BUT DUE TO A HEAVILY CALCIFIED LESION. THE PHYSICIAN COMPLETED THE PROCEDURE USING TWO 3.0X15MM RESOLUTE ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14451106 ↗
• InjuryJan 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED WITH A SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13332217 ↗
• MalfunctionJan 20, 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 NON-TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE OSTIAL-PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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.  IT WAS REPORTED THAT THE STENT GOT STUCK AT THE ENTRY PORT OF THE 5.5 NON-MEDTRONIC GUIDE EXTENSION CATHETER AND STENT DISLODGEMENT OCCURRED. IT WAS STATED THAT THE STENT NEVER REACHED THE VESSEL. THE DISLODGED STENT WAS REMOVED IN CONJUNCTION WITH THE GUIDE EXTENSION CATHETER. THE PHYSICIAN REMOVED EVERYTHING INCLUDING THE GUIDE WIRE AND THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDE CATHETER, GUIDE WIRE AND GUIDE EXTENSION CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13304444 ↗
• MalfunctionSep 21, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE A RESOLUTE ONYX DEVICE WAS BEING USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM). NO DAMAGE WAS NOTED TO THE PACKAGING, NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY, THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION SO THE LESION WAS DILATED WITH A COMPLIANT BALLOON. THE STENT AGAIN FAILED TO CROSS THE LESION, IT WAS THEN NOTED TO HAVE DAMAGED STRUTS. THE DEVICE WAS DISCARDED. THE LESION WAS AGAIN DILATED WITH AN NON COMPLIANT (NC) BALLOON AND TWO RESOLUTE ONYX DEVICES WERE SUCCESSFULLY IMPLANTED IN THE OBTUSE MARGINAL. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12505161 ↗
• 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 12107486 ↗
• MalfunctionJun 16, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS 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 THE STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. ANOTHER RESOLUTE ONYX DES WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007641 ↗
• 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 11830679 ↗
• MalfunctionMar 24, 2021Material Deformation; Material Deformation

  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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE TELESCOPE WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TELESCOPE, HOWEVER RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF EITHER DEVICE. IT WAS REPORTED THAT STENT FAILED TO CROSS THE CALCIFIED LESION AND UPON REMOVAL OF THE STENT, A STENT STRUT WAS NOTED TO BE RAISED. IT WAS STATED THAT THE TELESCOPE MAY HAVE CAUSED THE DEFORMATION. IT WAS ALSO STATED THAT TWO NON MEDTRONIC BALLOONS WERE USED DURING THE PROCEDURE, ONE BALLOON BURST AND THE OTHER BALLOON SHAFT BROKE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563786 ↗
• MalfunctionMar 3, 2021Material Deformation; 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 MID CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. IT WAS STATED THAT AFTER REINSERTING AND REMOVING THE STENT WAS DAMAGED. THE LESION WAS DILATED MORE AND ANOTHER 3X26MM STENT WAS USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404395 ↗
• InjuryNov 19, 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 2ND OBTUSE MARGINAL AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. IT WAS REPORTED THAT ON THE SAME DAY POST INDEX PROCEDURE, PATIENT'S CARDIAC ENZYMES WERE ELEVATED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION IN THE 2ND OBTUSE MARGINAL (TARGET VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 10866490 ↗
• MalfunctionSep 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS RETURNED WITH THE STENT NOT PRESENT ON THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10605699 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX WERE IMPLANTED; ONE IN THE 1ST OBTUSE MARGINAL AND SECOND IN CX. APPROXIMATELY 15 MONTHS POST PROCEDURE, PATIENT SUFFERED CARDIAC CHEST PAIN REPORTED TO BE RELATED TO STENT THROMBOSIS IN THE STENT IMPLANTED IN 1ST OBTUSE MARGINAL. EVENT WAS TREATED WITH REVASCULARIZATION. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Thrombosis/Thrombus; Thrombus

  MAUDE report 10420470 ↗
• MalfunctionJul 29, 2020Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  ONE RESOLUTE ONYX DES WAS USED TO TREAT A NON-TORTUOUS LESION IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A PINHOLE LEAK/BURST OCCURRED ON THE PROXIMAL BALLOON DURING STENT DEPLOYMENT. IT WAS STATED THAT THE STENT WAS ABLE TO BE DEPLOYED SAFELY WITH NO PATIENT ISSUES OR COMPLICATIONS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10338074 ↗
• MalfunctionJul 17, 2020Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION EXHIBITING 80% STENOSIS LOCATED IN THE FIRST OBTUSE MARGINAL ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED PRIOR TO USE. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A STENT FRACTURE OCCURRED IN VIVO. IT WAS STATED THAT THE FRACTURE WAS NOTED UNDER X-RAY AND THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT OF THE SAME SIZE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288568 ↗
• 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 TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE MID CX ARTERY WITH 70% STENOSIS. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED USING A 2.5 X 20 MM EUPHORA BALLOON TWICE AT 14 ATMS. 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 ONYX (LOT 0009213660) FAILED TO CROSS THE LESION AFTER TWO ATTEMPTS, AFTER THE SECOND ATTEMPT THE STENT WAS REMOVED AND STENT STRUTS WERE NOTED TO BE STICKING UP. A SECOND ONYX (LOT 0009139990) WAS THEN ATTEMPTED TO BE USED BUT THIS ALSO FAILED TO CROSS THE LESION AND ON REMOVAL BECAME DISLODGED INSIDE THE TOUEY. A NON MEDTRONIC STENT AND A NON MEDTRONIC BALLOON CATHETER WERE THEN USED BUT ALSO FAILED TO CROSS THE LESION. THE LESION WAS DILATED USING A 3.0 X 20 NC EUPHORA BALLOON ANDINFLATED TO 24 ATMS. A 3.0 X 22 RESOLUTE ONYX THEN PASSED THE LESION AND WAS SUCCESSFULLY DEPLOYED THE THE MID CX. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263406 ↗
• MalfunctionJun 19, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT AND THE STENT COULD ONLY BE INFLATED TO 6 ATM. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173225 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE 1ST DIAGONAL GRAFT (RONYX50030UX), ONE IN THE CX (RONYX30026UX) AND ONE IN THE LEFT MAIN (RONYX30030UX) CEC RE-ADJUDICATED MI OF THE TARGET VESSEL, THE LCMA, CX, 1ST OBTUSE MARGINAL AND THE 1ST DIAGONAL GRAFT.

  Patient problems: Myocardial Infarction

  MAUDE report 9903078 ↗
• DeathMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE 1ST DIAGONAL, TWO IN THE LAD AND TWO IN THE CX. APPROXIMATELY 13 MONTHS LATER THE PATIENT SUFFERED CVA/STROKE TREATED WITH HOSPITALIZATION, TPA AND MECHANICAL THROMBECTOMY AND PEG TUBE PLACEMENT. THE PATIENT IS RECOVERING. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 9864472 ↗
• DeathMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE 1ST DIAGONAL, TWO IN THE LAD AND TWO IN THE CX. APPROXIMATELY 13 MONTHS LATER THE PATIENT SUFFERED CVA/STROKE TREATED WITH HOSPITALIZATION, TPA AND MECHANICAL THROMBECTOMY AND PEG TUBE PLACEMENT. THE PATIENT IS RECOVERING. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 9864467 ↗
• InjuryMar 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 9779099 ↗
• InjuryFeb 20, 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 CX. FOUR DAYS POST PROCEDURE, PATIENT SUFFERED CARDIOGENIC SHOCK AND WAS TREATED WITH BLOOD TRANSFUSION AND VASOPRESSORS. PATIENT NOT RECOVERED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED NON-Q-WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS. CEC COMMENTED MI FROM CARDIOGENIC SHOCK/BLEEDING - OUTSIDE OF PERI-PCI WINDOW. NO SIDE BRANCH OCCLUSION OCCURRED.

  Patient problems: Myocardial Infarction

  MAUDE report 9731606 ↗
• MalfunctionFeb 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER BROKE IN HALF DURING DELIVERY THROUGH THE VESSEL. IT WAS STATED THAT IT WAS DIFFICULT TO CROSS THE LESION WITH THE STENT AND MUCH FORCE AND TORQUE WAS USED. THE CATHETER BROKE IN HALF AFTER THE FORCE AND TORQUE TECHNIQUES USED. THE ENTIRE CATHETER AND STENT WAS REMOVED FROM THE PATIENT'S CORONARY ARTERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9715887 ↗
• 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 9635933 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM, PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). 100% STENOSIS WAS PRESENT. ALL DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL FOUR DEVICES WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL FOUR DEVICES BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ANY OF THE DEVICES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION AND AN MI OCCURRED IN RELATION TO THE TARGET VESSEL 7 HOURS POST STENT IMPLANTATION. THE CLOT WAS REMOVED BY ASPIRATION WITH A NON MEDTRONIC DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9591011 ↗
• DeathNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONE RESOLUTE ONYX DEVICE WAS IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE THAT THE PATIENT DIED OF AN UNKNOWN CAUSE. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE PROCEDURE OR DEVICE.

  Patient problems: Death; Septic Shock

  MAUDE report 9310457 ↗