Resolute Onyx™ RONYX30012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00643169556973), received between Sep 19, 2017 and Dec 14, 2023 — classified as 5 deaths, 43 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS RETURNED. IT WAS INDICATED THAT THE STENT FAILED TO CROSS THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325409 ↗
• MalfunctionDec 5, 2022Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT DEVICE TO TREAT A NON TORTUOUS, SEVERLY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING, NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION AT 12 ATM. IT WAS REPORTED THAT THE PATIENT WAS ALIVE WITH INJURY. IT WAS STATED THAT THE PATIENT HAD CHEST PAIN 8/10 WITH NO FLOW, THE PATIENT IS REPORTED TO BE FINE AFTER HOSPITAL STAY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915828 ↗
• InjurySep 1, 2022Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS, IN THE MID LEFT ANTERIOR DESCENDING (LAD) 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. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS DETAILED THAT A NON MEDTRONIC GUIDEWIRE WAS BEING USED DURING THE PROCEDURE. SOME BENDS WERE IDENTIFIED AT THE END OF THE GUIDEWIRE. A DECISION WAS MADE TO CUT THE PROXIMAL END OF THE WIRE RATHER THAN CHANGE THE WIRE AND REMOVE IT FROM POSITION IN THE ARTERY. THE RESOLUTE ONYX DEVICE WAS LOADED ONTO THE WIRE AND ADVANCED TO THE LESION. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON HOWEVER THE PRESSURE DID NOT INCREASE AND THE STENT WAS NOT DEPLOYING. THE DEVICE WAS PULLED BACK HOWEVER THE STENT DISLODGED IN THE LESION. IT WAS DETAILED THAT IT WAS POSSIBLE TO LOAD AN NC BALLOON OVER THE WIRE AND GET IT INSIDE THE DISLODGED STENT. THE STENT WAS

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

  MAUDE report 15335200 ↗
• InjuryMay 31, 2022Device 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 MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE OM AT A DIFFERENT LOCATION THAN THE TARGET LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 14547423 ↗
• InjuryMay 23, 2022Device 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, NON-C ALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED AND WAS CRUSHED USING ANOTHER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14468907 ↗
• MalfunctionFeb 1, 2022Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMEDWITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED.  IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT. 10 ATM OF PRESSURE WAS APPLIED THROUGH THE INDEFLATOR BUT IT WAS OBSERVED ON THE ANGIOGRAM THAT THE BALLOON HAD NOT INFLATED. CONTRAST WAS REMOVED FROM THE BALLOON, ANOTHER NEGATIVE PREP WAS PERFORMED AND 10 ATM OF PRESSURE APPLIED AGAIN BUT THE BALLOON STILL DID NOT INFLATE. THE RESOLUTE ONYX DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED WITH NO ISSUES FOUND ON THE SHAFT OR THE BALLOON. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING A DIFFERENT RESOLUTE ONYX STENT AND THE SAME INDEFLATOR. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13413406 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS AND CALCIFIED LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT WOULD NOT CROSS THE LESION AND WHEN REMOVING THE STENT CATHETER IT BECAME STUCK ON THE NON MEDTRONIC GUIDE EXTENSION CATHETER. IT WAS ALSO REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. UPON REMOVAL OF THE STENT CATHETER, IT WAS NOTICED THAT THE STENT WAS NOT PRESENT. THE STENT WAS THEN REMOVED WITHIN THE NON-MEDTRONIC GEC. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13278266 ↗
• DeathOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE RCA. APPROXIMATELY 31 MONTHS POST PROCEDURE PATIENT DIED DUE TO MULTI-ORGAN FAILURE, INCLUDING CARDIOPULMONARY AND RENAL FAILURE. THE PATIENT WAS ON DIALYSIS AT TIME OF DEATH. THE CLASSIFICATION OF DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12680345 ↗
• InjuryMay 24, 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 IN THE OSTIUM SAPHENOUS VEIN GRAFT (SVG) WITH 99% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED. 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/AT LESION. A 6F GUIDE WAS ADVANCED, AND THE VEIN GRAFT TO THE RIGHT CORONARY ARTERY WAS SUCCESSFULLY CANNULATED. A 190 CM NON-MEDTRONIC WIRE WAS THEN ADVANCED AND THE LESION IN THE OSTIUM OF THE VEIN GRAFT WAS SUCCESSFULLY CROSSED. THIS LESION WAS PRE-DILATED WITH 3.0X12 MM NON-MEDTRONIC BALLOON. ANGIOGRAM REVEALED A GOOD BALLOON ANGIOPLASTY RESULT, HOWEVER, STILL SIGNIFICANT RESIDUAL STENOSIS. THE RESOLUTE ONYX DRUG-ELUTING STENT WAS THEN ADVANCED AND WHILE PLACING THE STENT THE UNDEPLOYED STENT CAME OFF THE BALLOON AND WAS STUCK AT THE OSTIUM AND SITE OF THE LESION. THE WIRE WAS STILL IN PLACE. AN ATTEMPT WAS MADE TO PULLBACK THE STENT WITH THE WIRE, BUT WAS NOT SUCCESSFUL AS THE STENT WAS AL

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11869988 ↗
• InjuryMay 10, 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 CX. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED FROM ACUTE GI HEMORRHAGE. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED. IT IS UNKNOWN IF THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. CEC ADJUDICATED THE EVENT AS BLEEDING COMPLICATION.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 11796308 ↗
• InjuryApr 15, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT ATTEMPTS WERE BEING MADE TO STENT DISTAL TO A STENT THAT HAD BEEN IMPLANTED MANY YEARS AGO. THE STENT KEPT GETTING STUCK ON THE PREVIOUSLY DEPLOYED STENT. A GUIDE EXTENSION CATHETER (GEC) WAS USED AND IT IS BELIEVED THAT THE STENT FELL OFF WHEN ATTEMPTING TO BRING THE STENT BACK INTO THE GEC. IT WAS STATED THAT AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT USING A GOOSENECK SNARE, HOWEVER THIS WAS NOT SUCCESSFUL. THE STENT WAS THEN BALLOONED/CRUSHED AGAINST THE ARTERY WALL. ANOTHER STENT WAS NOT PLACED OVER THE DISLODGED STENT TO COVER IT. THE PATIENT IS BEING SENT FOR SURGICAL CONSULTATION TO

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11669964 ↗
• MalfunctionApr 7, 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 IN THE LAD. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS NOT INSPECTED. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON IN THE LEFT MAIN ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626197 ↗
• DeathMar 29, 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 AND ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11580799 ↗
• MalfunctionMar 23, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 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 WAS DEPLOYED IN THE ARTERY WHERE IT CAME OFF THE DELIVERY SYSTEM. A 1.0 MM BALLOON WAS INFLATED INSIDE THE STENT FOLLOWED BY A 3.0 MM BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554324 ↗
• InjuryMar 9, 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, MODERATELY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) 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 NOT 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 THE STENT WAS UNABLE TO MAKE THE 90 DEGREE TURN IN THE VESSEL, HOWEVER 20+ ATTEMPTS WERE MADE TO CROSS THE BEND AND THE STENT DISLODGED. THE PATIENT WAS SENT TO SURGERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES AND IS RECOVERING.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11445040 ↗
• MalfunctionFeb 9, 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 MID RCA LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299903 ↗
• MalfunctionFeb 8, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292800 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE RCA. APPROXIMATELY 23 MONTHS POST PROCEDURE THE PATIENT SUFFERED NSTEMI. IT IS UNKNOWN IF THE TARGET VESSEL WAS INVOLVED. DIAGNOSTIC PROCEDURES WERE CARRIED OUT BUT NO INTERVENTION. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 11129865 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST DIAGONAL. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED LOWER GI BLEED. IT WAS STATED THAT THE EVENT WAS FROM INTERNAL HEMORRHOIDS EXACERBATED BY THERAPEUTIC ANTI-COAGULATION. PATIENT WAS HOSPITALIZED, GIVEN TWO UNITS OF PACKED RED BLOOD CELLS, IRON PILLS AND HEMORRHOIDECTOMY CARRIED OUT. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTI PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND NOT RELATED TO THE INDEX DEVICE. SAFETY COMMENTED "LOWER GI BLEED (INTERNAL HEMORRHOIDS). SUBJECT ON AGGRESSIVE ANTICOAGULANT FOR PE". THE SITE REPORTED THAT THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT.

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

  MAUDE report 10821934 ↗
• DeathSep 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 1ST DIAGONAL. APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ACUTE CHRONIC DECOMPENSATED HEART FAILURE, MEDICATION WAS GIVEN BUT PATIENT DIED. DEATH WAS CLASSIFIED AS UNKNOWN. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death; Heart Failure/Congestive Heart Failure

  MAUDE report 10585229 ↗
• DeathAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX RX STENTS WERE IMPLANTED BETWEEN THE DISTAL LAD WHICH HAD A CHRONIC TOTAL OCCLUSION AND THE PROX LAD WHICH HAD NO OCCLUSION. APPROXIMATELY 32 MONTHS LATER THE PATIENT SUFFERED CARDIOGENIC SHOCK AND CHEST PAIN. THE PATIENT WAS TREATED WITH MEDICATION. WITHIN 24 HOURS THE PATIENT PRESENTED TO ER WITH W/C/O CP & SOB; BRADYCARDIC FOLLOWED BY CARDIAC ARREST. THE PATIENT DIED DUE TO CARDIOGENIC SHOCK. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO INDEX DEVICE AND ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Cardiogenic Shock; Death; Myocardial Infarction

  MAUDE report 10447100 ↗
• 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 10337112 ↗
• MalfunctionApr 14, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN A DISTAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE END OF THE STENT WAS NOTED TO BE RUFFLED. IT WAS STATED THIS MAY HAVE BEEN CAUSED FROM RUBBING AGAINST THE GUIDELINER. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT OF THE SAME SIZE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9956688 ↗
• InjuryMar 23, 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 LOCATED IN THE PROXIMAL 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. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT A DIRECT STENT WAS ATTEMPTED FIRST BUT WAS UNSUCCESSFUL SO A BALLOON WAS USED TO PRE-DILATE THE LESION. THE STENT WAS ATTEMPTED TO BE USED FOR THE SECOND TIME. IT WAS STATED THAT CALCIUM WAS FELT GRINDING ON THE STENT. THE STENT FAILED TO CROSS THE LESION AND DURING REMOVAL IT POSSIBLY CAUGHT ON SOME CALCIUM AND THE STENT STARTED COMING OFF THE BALLOON. THE BALLOON WAS PUT BACK THROUGH THE STENT AND IT WAS DEPLOYED A LITTLE MORE PROXIMAL IN THE CX ARTERY TO WHERE IT WAS INTENDED TO BE DEPLOYED AND INTO DISTAL LEFT MAIN AND JAILED THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS REPORTED TO BE ALI

  Patient problems: Injury; Occlusion

  MAUDE report 9864632 ↗
• InjuryMar 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% 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 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 DELIVERY TO A LESION. IT WAS STATED AN ATTEMPT WAS MADE TO DELIVER A RESOLUTE ONYX STENT (3.0 X 38MM) TO THE DISTAL LESION, HOWEVER IT FAILED TO DELIVER DUE TO EXCESSIVE TORTUOSITY. THIS STENT WAS DEPLOYED AT THE PROXIMAL RCA LESION. FOLLOWING THIS, AN ATTEMPT WAS MADE TO DELIVER A SHORTER RESOLUTE ONYX STENT (3.0 X 12MM) TO THE DISTAL LESION, THROUGH THE FRESHLY DEPLOYED RESOLUTE ONYX STENT (3.0 X 38MM), USING A GUIDELINER, AND THIS STENT DISLODGED OFF THE DELIVERY SYSTEM. IT WAS STATED THAT THE WIRE POSITION WAS LOST. UPON RE-WIRING THE RCA, IT WAS NOTICED THAT THE WIRE WAS OUTSIDE THE DISLODGED STENT. THE STENT WAS IMPLANTED BY CRUSHING IT I

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9785138 ↗