Resolute Onyx™ RONYX40015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169557161), received between Oct 3, 2017 and Oct 3, 2024 — classified as 2 deaths, 20 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 31 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress; Burst Container or Vessel; Leak/Splash; Deformation Due to Compressive Stress

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A BALLOON BURST/LEAK OCCURRED DURING STENT DEPLOYMENT. THE STENT CATHETER WAS PUT IN POSITION AND WHEN AN ATTEMPT WAS MADE TO INFLATE THE DEVICE NO PRESSURE SHOWED ON THE INFLATION DEVICE. THE INFLATION DEVICE WAS CONTINUED TO BE ROTATED BUT THERE WAS NO PRESSURE GOING INTO THE BALLOON, AND THE STENT WAS NOT EXPANDING. CONTRAST WAS SEEN JETTING BACK INTO THE AORTA AND IT WAS BELIEVED THAT THE BALLOON HAD RUPTURED. THE ISSUE OCCURRED ON THE FIRST INFLATION. A TOTAL OF 30CC OF CONTRAST WAS INJECTED TO EXPAND THE STENT ENOUGH TO BE ABLE TO REMOVE THE STENT DELIVERY SYSTEM AND GO BACK IN WITH AN NC BALLOON. THE PATIENT EXPERIENCED ST'S HOWEVER REMAINS STABLE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Arrhythmia; Insufficient Information

  MAUDE report 20357992 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE INDEX PROCEDURE FOUR NC EUPHORA BALLOON CATHETERS AND ONE LAUNCHER GUIDE CATHETER WERE USED AND THERE WERE NO ISSUES NOTED WITH THESE DEVICES. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT SUFFERED INTERMITTENT CHEST PAIN AND A MYOCARDIAL INFARCTION. THE PATIENT PRESENTED DUE TO INTERMITTENT CHEST PAIN WITH NAUSEA AFTER GETTING A PERMCATH REPLACED FOLLOWING A MISSING DIALYSIS. THE PATIENT HAD ELEVATED TROPONIN LEVELS AND THE PATIENT WAS DIAGNOSED WITH A SPONTANEOUS MYOCARDIAL INFARCTION. THE LOCATION OF WHERE THE MYOCARDIAL INFARCTION OCCURRED IS NOT KNOWN. DUE TO UNDERLYING METASTATIC LUNG CANCER WITH PROGRESSIVE FUNCTIONAL AND GENERAL HEALTH DECLINE AND POOR TOLERANCE OF TREATMENTS, A HEART CATH WAS NOT PURSUED. INSTEAD PALLIATIVE CARE WAS CONSULTED. THE EVENT WAS TREATED WITH ASPIRIN AND PALLIATIVE CARE. IT IS UNKNOWN IF DUAL ANTIPLATELET THERAPY WAS HELD FOR PERMCATH PROCEDURE AND IT IS UNKNOWN IF THE HOLDING OF THE ANTIPLATELET THERAPY LED TO THE CHEST PAIN. PATIENT HAS NOT RECOVERED.

  Patient problems: Cardiac Enzyme Elevation; Chest Pain; Myocardial Infarction; Nausea

  MAUDE report 18523830 ↗
• InjuryJan 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OSTIUM CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS CRUSHED AGAINST THE PROXIMAL CX VESSEL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16136456 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RESOLUTE ONYX CORONARY DRUG ELUTING STENT IMPLANTED AFTER PRESENTING WITH A HEART ATTACK. IT WAS INDICATED THAT THE RESOLUTE ONYX STENT WAS IMPLANTED INSIDE A PREVIOUSLY IMPLANTED STENT WHICH WAS IMPLANTED SEVERAL YEARS PREVIOUSLY. APPROXIMATELY 8 MONTHS POST IMPLANTED OF THE RESOLUTE ONYX STENT THE PATIENT SUFFERED ANOTHER HEART ATTACK WHICH WAS CONTRIBUTED TO A 90% BLOCKAGE IN THE PREVIOUSLY IMPLANTED ONYX STENT. THE BLOCKAGE WAS NOTED DURING A HEART CATHERIZATION ONE DAY AFTER THE PATIENT PRESENTED WITH A HEART ATTACK.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 12201134 ↗
• InjuryMay 26, 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 AND SEVERELY CALCIFIED 90 DEGREE ANGULATED LESION IN THE PROXIMAL CX ARTERY WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED/ PRETREATED USING NON MEDTRONIC DEVICES AND SC AND NC BALLOONS. 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 WOULD NOT ADVANCE AND WHEN PULLED BACK IT WAS REALISED THAT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED USING A 3.50 X 12 RESOLUTE ONYX STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11884313 ↗
• InjuryFeb 22, 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 CIRCUMFLEX. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CARDIAC CHEST PAIN .IT WAS STATED THAT A ISCHEMIA AROUND THE PATIENT'S CHRONICALLY OCCLUDED RCA WAS NOTED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION (UNKNOWN VESSEL). PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11357225 ↗
• MalfunctionJan 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 STENT DISLODGEMENT OCCURRED DURING INSERTION INTO HOMEOSTATIC VALVE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250210 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT AND ONE 6 FRENCH TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE TELESCOPE GEC WAS REMOVED FROM PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE RESOLUTE ONYX WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED WHEN TRYING TO RETRIEVE THE STENT INSIDE THE 6 FRENCH TELESCOPE. IT WAS STATED THAT A PREVIOUS STENT WAS PLACED IN THE DISTAL RCA IN 3 YEARS AGO THAT HAD THROMBUS INSIDE THE STENT AND NOW A NEW LESION IN THE MID RCA WAS NOTED. THE TELESCOPE GEC WAS PLACED TO PROVIDE SUPPORT FOR STENTING. A RESOLUTE ONYX 3.0 X 22 STENT WAS PLACED AND DEPLOYED SUCCESSFULLY INSIDE THE OLD STENT WITH THROMBUS. A SECOND STENT ONYX 4.0 X 15 WAS ADVANCED THROUGH THE DISTAL STENTED AREA AND

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10982256 ↗
• InjuryNov 6, 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 THE LESION. IT WAS STATED DURING ADVANCEMENT THROUGH THE LESION THE STENT CAME OFF THE BALLOON. IT WAS NOTED TO BE STILL ON THE WIRE BUT NOT IN THE CORRECT POSITION. A SMALLER BALLOON WAS PUT INTO THE STENT AND IT WAS BALLOONED UP TO THE CORRECT SIZE AND DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT IN THE CORRECT POSITION WHICH OVERLAPPED THE FIRST STENT BUT NO ISSUES WERE NOTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10799580 ↗
• MalfunctionJun 25, 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 NON-TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 USED. IT WAS REPORTED THAT PARTIAL STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE STENTS DID NOT EXIT THE GUIDE CATHETER AND THEY GOT STUCK TRYING TO GO AROUND THE GUIDE CURVE. THERE WAS TWO STENTS IN THE GUIDE AT THE SAME TIME, TRYING TO ATTEMPT A V STENT. THERE WAS A 3.0 RESOLUTE ONYX STENT PLACED IN THE OSTIAL RAMUS AND AN ATTEMPT WAS BEING MADE TO DELIVER A 4.0 RESOLUTE ONYX STENT THROUGH THE GUIDE AT THE SAME TIME THE 3.0 RESOLUTE ONYX STENT WAS THERE, HOWEVER IT WOULDN¿T FIT THROUGH THE 6F JL35 LAUNCHER GUIDE CATHETER. IT WAS STATED THAT THE STENTS WERE SUCCESSFULLY REMOVED FROM THE GUIDECATHETER AS THE STENTS WERE STILL PARTIALLY ATTACHED ONTO THE DELIVERY BA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194002 ↗
• MalfunctionJun 25, 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 NON-TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 USED. IT WAS REPORTED THAT PARTIAL STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE STENTS DID NOT EXIT THE GUIDE CATHETER AND THEY GOT STUCK TRYING TO GO AROUND THE GUIDE CURVE. THERE WAS TWO STENTS IN THE GUIDE AT THE SAME TIME, TRYING TO ATTEMPT A V STENT. THERE WAS A 3.0 RESOLUTE ONYX STENT PLACED IN THE OSTIAL RAMUS AND AN ATTEMPT WAS BEING MADE TO DELIVER A 4.0 RESOLUTE ONYX STENT THROUGH THE GUIDE AT THE SAME TIME THE 3.0 RESOLUTE ONYX STENT WAS THERE, HOWEVER IT WOULDN¿T FIT THROUGH THE 6F JL35 LAUNCHER GUIDE CATHETER. IT WAS STATED THAT THE STENTS WERE SUCCESSFULLY REMOVED FROM THE GUIDE CATHETER AS THE STENTS WERE STILL PARTIALLY ATTACHED ONTO THE DELIVERY B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10193978 ↗
• InjuryJun 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 LESION LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY/ CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/ AT THE LESION. IT WAS STATED THAT THE STENT DISLODGED FROM THE BALLOON WITHIN THE LM CORONARY ARTERY/ OSTIAL LEFT CX. A GUIDE EXTENDER WAS ABLE TO ADVANCE OVER THE DISLODGED STENT. A 2.0MM BALLOON WAS THEN ADVANCED THROUGH THE STENT AND INFLATED TO 6ATMS AT THE DISTAL EDGE WITH THE GUIDE EXTENDER. THE BALLOON AND GUIDELINE DEVICE WERE THEN REMOVED TOGETHER WITH SUCCESSFUL RETRIEVAL OF THE DISLODGED RESOLUTE ONYX STENT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10184042 ↗
• MalfunctionMay 13, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING, AND 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, AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING/ADVANCEMENT OF THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.0X15MM DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10050630 ↗
• DeathApr 30, 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 GRAFT 2ND OM AND GRAFT 3RD OM. APPROXIMATELY 16, PATIENT SUFFERED SUSTAINED VENTRICULAR TACHYCARDIA AND DIED SAME DAY. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10013083 ↗
• DeathApr 15, 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 AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LCMA. ANOTHER RESOLUTE ONYX DES WAS ALSO IMPLANTED. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM VENTRICULAR TACHYCARDIA AND DIED. EVENT WAS TREATED WITH MEDICATION, CPR AND ICD FIRED SHOCK. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9961684 ↗
• InjuryJan 24, 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 LAD AND RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT SUFFERED HEMORRHAGIC SHOCK DUE TO GI BLEED AND WAS TREATED WITH BLOOD TRANSFUSION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9626506 ↗
• MalfunctionJan 3, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION, THE DEVICE WAS REMOVED FROM THE PATIENT AND STENT DEFORMATION WAS NOTICED WHICH OCCURRED DURING THE INITIAL ATTEMPT TO CROSS THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9543805 ↗
• InjurySep 27, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION EXHIBITING 80% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS CRUSHED IN THE AXILLARY ARTERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9129030 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS IMPLANTED. IT IS REPORTED THAT THE PATIENT IS HAVING ITCHING ALL OVER THEIR BODY WHICH WAKES THEM UP AT NIGHT. THE PATIENT IS WORKING WITH AN ALLERGIST AND TRYING DIFFERENT COMBINATIONS OF DRUGS.

  Patient problems: Itching Sensation; Reaction

  MAUDE report 8767243 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE LCMA. APPROX. 1.5 WEEKS POST INDEX PROCEDURE MELANIC BOWEL MOVEMENT WAS REPORTED. THE PATIENT WAS TREATED WITH A BLOOD TRANSFUSION. THE PATIENT WAS TAKING DAPT AT THE TIME OF THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND CASUALLY RELATED TO THE ANTIPLATELET MEDICATION. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION. THE PATIENT IS RECOVERING.

  Patient problems: Blood Loss

  MAUDE report 8706864 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE CX. SIX DAYS POST PROCEDURE THE PATIENT SUFFERED A BLEEDING EVENT WITH ACUTE BLOOD LOSS ON CHRONIC ANEMIA AND COMPLAINT OF 3 DAYS OF MELENA. PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE EVENT WAS TREATED WITH MEDICATION CHANGE, BLOOD TRANSFUSION AND HEMOSTATIC CLIPS. PATIENT IS RECOVERED WITH SEQUELAE. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND PROBABLY RELATED TO THE ANTI-PLATELET MEDICATION. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 8602928 ↗
• MalfunctionMar 15, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON CALCIFIED LESION LOCATED IN THE OSTIUM OF RCA. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DURING AN ATTEMPT TO INFLATE THE STENT AT THE OSTIUM OF THE RCA AT A LESION SUSPECTED TO BE A DISSECTION, THAT THE PATIENT TOOK A DEEP BREATH, CAUSING THE ENTIRE DEVICE (STENT AND DELIVERY SYSTEM) TO RETREAT INTO THE AORTA ON THE PARTIALLY INFLATED BALLOON. THE STENT STAYED ON THE BALLOON IN ITS ORIGINAL POSITION THE ENTIRE TIME. THE STENT NEVER CAME OFF THE BALLOON WHILE IN THE PATIENT. IT STAYED ON THE PARTIALLY INFLATED BALLOON THE WHOLE TIME. THE BALLOON WAS KEPT INFLATED AND THE STENT WAS RETRIEVED ON THE BALLOON BACK THROUGH THE RIGHT RADIAL ARTERY ACCESS. NO FURTHER ATTEMPTS TO STENT ANY LOCATIONS WERE MADE. IT IS INDICATED THAT IT WAS LATER FOUND THAT THERE WAS NO ISSUE (DISSECTION) AT THE OSTIUM OF THE RCA. THE PATIENT IS REPORT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423973 ↗
• InjuryMar 12, 2019Device 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 80% STENOSIS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (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 HOWEVER EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT FOLLOWING A FAILED DELIVERY STENT DISLODGEMENT OCCURRED WHILE ATTEMPTING TO PULL BACK THE DEVICE ACROSS A 90 DEGREE BEND OF THE LEFT CIRCUMFLEX ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT HOWEVER IT WAS UNSUCCESSFUL. THE STENT MIGRATED DOWN THE CX TO THE VERY DISTAL PORTION OF THE OBTUSE MARGINAL. IT WAS DECIDED TO LEAVE THE STENT IN THE PATIENT UNDEPLOYED. THE PATIENT WAS SENT TO RECOVERY WITH NO INCIDENT.

  Patient problems: Injury

  MAUDE report 8412971 ↗
• InjuryFeb 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX 4.00X15MM DRUG ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE MID RCA, EXHIBITING MILD TORTUOSITY AND SEVERE CALCIFICATION. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE HOOP. DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT STENT DISLODGED DURING DELIVERY TO THE LESION. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. MULTIPLE NON-MEDTRONIC BALLOONS WERE USED TO PUSH THE STENT AGAINST THE WALL. THE DISLODGED STENT WAS THEN SUCCESSFULLY COVERED WITH A RESOLUTE ONYX 4.00X22MM. POST TIMI FLOW WAS 3, AND LESION WAS 0% STENOSIS AT THE END OF THE PROCEDURE. NO ISSUES IS REPORTED FOR THE SECOND STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8309612 ↗
• InjuryDec 21, 2018Adverse 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 LAD, ONE IN THE 1ST OBTUSE MARGINAL AND ONE IN THE 2ND OBTUSE MARGINAL. THE NEXT DAY, PATIENT SUFFERED A PCI RELATED MYOCARDIAL INFARCTION. IT WAS ASSESSED BY THE INVESTIGATOR THAT THE EVENT WAS NOT RELATED TO DEVICE OR DRUG.

  Patient problems: Myocardial Infarction

  MAUDE report 8188795 ↗