Resolute Onyx™ RONYX22512UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00643169556706), received between Jul 28, 2017 and Oct 15, 2024 — classified as 3 deaths, 40 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (29 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE ATTEMPTS WERE MADE TO USE TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE RESOLUTE ONYX STENT (LOT 0011927309) DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF BOTH DEVICES. IT WAS REPORTED THAT BOTH STENTS DISLODGED DURING DELIVERY THROUGH THE LESION. THE DISLODGED STENTS WERE REMOVED FROM THE PATIENT. WHEN THE RESOLUTE ONYX STENT (LOT NUMBER 0226461484) WAS REMOVED FROM THE PATIENT, THE STENT STRUTS WERE NOTED TO BE DAMAGED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 20449495 ↗
• MalfunctionJul 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THE PROTECTIVE WAS SHEATH REMOVED PER IFU. THE DEVICE WAS PREPPED PER IFU WITH NOT ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO OR AT THE LESION. THE DEVICE DID NOT REACH THE TARGET LESION. IT WAS DETAILED THAT THE STENT DISLODGED IN THE GUIDE CATHETER AND WAS REMOVED WITH THE STENT DELIVERY BALLOON. THE BALLOON FROM THE DELIVERY SYSTEM WAS INFLATED AND PULLED BACK TO THE SHEATH, THE STENT WAS THEN REMOVED OUT OF THE PATIENT¿S BODY. IT IS UNKNOWN IF PRIOR TO DISLODGEMENT THE DEVICE HAD EXITED THE TIP OF THE GUIDE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984392 ↗
• InjuryApr 12, 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 SEVERELY TORTUOUS, NON-CALCIFIED LESIONS EXHIBITING 90% STENOSIS LOCATED PROXIMAL AND IN THE OSTIUM OF THE OBTUSE MARGINAL 1(OM) AND LEFT CIRCUMFLEX (LCX) ARTERY. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS STATED THAT THE FIRST RESOLUTE ONYX (2.25X12MM, LOT 0010812652) WAS SUCCESSFULLY IMPLANTED AND DEPLOYED AT 12 ATM FOR 12 SECONDS IN THE OM1 PROXIMAL LESION WITH NO ISSUES NOTED. A NON-MEDTRONIC WIRE WAS THEN ADVANCED INTO THE LCX AND THE SECOND RESOLUTE ONYX (2.25X12MM, LOT 0010920874) STENT WAS ADVANCED ONTO THE WIRE. IT WAS REPORTED THAT THE STENT CAME OFF THE DELIVERY SYSTEM AND BALLOON BEFORE POSITIONING AND DEPLOYMENT. IT WAS STATED THAT THE STENT DISLODGED INTO THE VESSEL UNDEPLOYED. MULTIPLE ATTEMPTS WERE MADE TO OPPOSE THE STENT USING A NON-MEDTRONIC WIRE AND BALLOON, BUT ATTEMPTS MADE WERE UNSUCCESSFUL. THE PATIENT UNDERWENT CABG. POST PTCA ANGIOGRAM CONFIRMED REDUCTION IN THE STENOSIS FROM 90% TO 0% IN THE OM. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14084248 ↗
• InjuryApr 5, 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 AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A SEVERELY TORTUOUS AND ANGLED, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX. THE PATIENT WAS IN CARDIOGENIC SHOCK PRIOR TO THE PROCEDURE. THE RESOLUTE ONYX STENT WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT GOT CAUGHT ON THE TELESCOPE GEC DEVICE DURING REMOVAL AND THE STENT DISLODGED FROM THE BALLOON. NO ATTEMPT WAS MADE TO DEPLOY THE STENT. THE STENT WAS REMOVED WITH USE OF A SNARE. THERE WAS RESISTANCE UPON REMOVAL AND EXCESSIVE FORCE USED RESULTING IN STENT EMBOLIZATION. THE GUIDEWIRE WAS NOT DAMAGED. THE PHYSICIAN BELIEVES THE EVENT WAS SOLELY DUE TO THE PATIENT'S SEVERE CALCIUM AND TORTUOSITY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14011835 ↗
• MalfunctionJan 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS FOUND IN THE NON-MEDTRONIC GUIDE EXTENSION CATHETER AND WAS REMOVED THROUGH NORMAL CATHETER RETRIEVAL PROCESS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235051 ↗
• InjuryDec 15, 2021Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT THE STENT WAS DEPLOYED AT 8ATM BUT AT THE TIME OF INFLATION THE STENT CAME LOOSE AND FLOATED DOWNSTREAM. A SECOND STENT WAS DEPLOYED TO CRUSH THE DISLODGED STENT AGAINST THE ARTERIAL WALL. NO FURTHER PATIENT INJURY IS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13009171 ↗
• MalfunctionJun 24, 2021Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A BIFURCATION LESION IN THE PROXIMAL CX ARTERY. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND BECAME DAMAGED WHILE TRYING TO CROSS THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059062 ↗
• InjuryJun 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY CALCIFIED PROXIMAL LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. A SNARE REMOVAL WAS ATTEMPTED BUT THE SNARE, WIRE AND STENT BECAME ENTANGLED. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM AND THE ENTANGLED STENT, WIRE AND SNARE WERE SURGICALLY REMOVED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11974313 ↗
• InjuryMay 17, 2021Device 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 TO TREAT A LESION. IT WAS NOTED THAT THERE WAS CALCIFICATION IN THE LM ARTERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DEVICE WAS REMOVED USING A SNARE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11830814 ↗
• MalfunctionApr 21, 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, SEVERELY CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE MID/DISTAL 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699069 ↗
• DeathMar 15, 2021Adverse 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 1ST DIAGONAL. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED RESPIRATORY FAILURE, SEPTIC SHOCK, PULSELESS ELECTRICAL ACTIVITY AND RENAL FAILURE. PATIENT WAS INTUBATED AND DIALYSIS WAS STARTED BUT THE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Cardiac Arrest; Sepsis

  MAUDE report 11479426 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT IMPLANTED. TWO DAYS POST PROCEDURE THE PATIENT STATES HAVING DIFFERENT REACTIONS INCLUDING SWELLING BESIDE THE RIGHT EYE, BACK RASH AND TINGLING IN LEGS. THE PATIENT IS ON SEVERAL MEDICATIONS AND IS WORKING WITH CARDIOLOGIST ON DIFFERENT MEDICATION COMBINATIONS TO TRY TO RESOLVE THE DIFFERING REACTIONS.

  Patient problems: Local Reaction

  MAUDE report 11153263 ↗
• InjuryDec 14, 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, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 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 NOT REMOVED FROM THE PATIENT. THE STENT WAS CRUSHED AGAINST THE WALL OF THE PROXIMAL LAD AND ANOTHER STENT WAS DEPLOYED OVER THE CRUSHED STENT ALLOWING FOR A FULL PATENT ARTERY WITH TIMI 3 FLOW. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11001596 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS IN THE DIAGONAL BRANCH AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT A POSSIBLE DRUG ERUPTION OCCURRED. IT WAS STATED THAT 3 DAYS AFTER HOSPITALISATION THE PATIENT HAD A BLISTERING RASH THAT WRAPPED FROM THE LEFT SPINE TOWARDS THE LEFT HIP AND THAT SINGULAR BLISTERS OCCURRED THAT WERE ERUPTING ON THE PATIENTS NECK, LIMBS AND TRUNK. IT WAS STATED THAT THE PATIENT IS ALSO TAKING SEVERAL NEW MEDICATIONS. THE PATIENT SUFFERS ALLERGIES FROM SULFA AND TYLENOL. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 10926403 ↗
• InjuryNov 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TWO 2.25 X 12 MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE USED DURING A PROCEDURE TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID CX. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT THE FIRST 2.25 X 12 MM STENT DEFORMED AT THE DISTAL END AFTER A NUMBER OF ATTEMPTS TO PASS THE 1ST MARGINAL, WHICH HAD BEEN STENTED EARLIER IN THE PROCEDURE. THE SECOND 2.25 X 12 MM STENT WAS ATTEMPTED, ALONG WITH A GUIDELINER, BUT GOT STUCK AT THE SAME POINT AS THE FIRST STENT. IT WAS REPORTED THAT DURING REMOVAL THE STENT DISLODGED AT THE OSTIUM OF THE 1ST MARGINAL. AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE BUT WAS UNSUCCESSFUL SO THE STENT WAS LEFT IN PLACE. A 3.5X12MM AND A 3.5X8MM RESOLUTE ONYX STENT WERE DEPLOYED, WITH THE DISLODGED STENT SECURED BETWEEN THE STENTS AGAINST THE ARTERIAL WALL. A THIRD 2.25X12MM RESOLUTE ONYX WAS THEN PASSED THROUGH THE 3.5X12MM AND THE 3.5X8MM ONYX STENTS AND DEPLOYED SUCCESSFULLY, DISTAL TO THE 1ST MARGINAL. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10911324 ↗
• MalfunctionNov 26, 2020Material Deformation; Material Deformation

  TWO 2.25 X 12 MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE USED DURING A PROCEDURE TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID CX. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT THE FIRST 2.25 X 12 MM STENT DEFORMED AT THE DISTAL END AFTER A NUMBER OF ATTEMPTS TO PASS THE 1ST MARGINAL, WHICH HAD BEEN STENTED EARLIER IN THE PROCEDURE. THE SECOND 2.25 X 12 MM STENT WAS ATTEMPTED, ALONG WITH A GUIDELINER, BUT GOT STUCK AT THE SAME POINT AS THE FIRST STENT. IT WAS REPORTED THAT DURING REMOVAL THE STENT DISLODGED AT THE OSTIUM OF THE 1ST MARGINAL. AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE BUT WAS UNSUCCESSFUL SO THE STENT WAS LEFT IN PLACE. A 3.5X12MM AND A 3.5X8MM RESOLUTE ONYX STENT WERE DEPLOYED, WITH THE DISLODGED STENT SECURED BETWEEN THE STENTS AGAINST THE ARTERIAL WALL. A THIRD 2.25X12MM RESOLUTE ONYX WAS THEN PASSED THROUGH THE 3.5X12MM AND THE 3.5X8MM ONYX STENTS AND DEPLOYED SUCCESSFULLY, DISTAL TO THE 1ST MARGINAL. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10911322 ↗
• InjuryNov 26, 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE DISTAL LEFT MAIN (LM) CORONARY 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS NOT REMOVED, AND WAS CRUSHED AGAINST THE WALL OF THE DISTAL LEFT MAIN ARTERY USING A 5MMX8MM NC BALLOON. IT WAS STATED THAT AN ATTEMPT WAS MADE TO PUSH THE STENT OUT OF THE LEFT MAIN INTO THE CIRCUMFLEX WITH A 1.5MM BALLOON, BUT THAT WAS NOT SUCCESSFUL. IT WAS STATED THAT THE LESION WAS LEFT UNTREATED. THE PATIENT WAS TO BE CONSULTED FOR POSSIBLE NON URGENT BYPASS SURGERY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10910684 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, FOUR RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX. TWO EUPHORA PTCA BALLOON WERE ALSO USED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED CARDIAC ENZYMES. INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED. THE CEC ADJUDICATED THAT A MI OCCURRED IN THE TARGET VESSEL, THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 10894225 ↗
• InjuryOct 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX DES WAS USED DURING A PROCEDURE TO TREAT A MODERATE TORTIOUS, MODERATE CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM). THERE WAS NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE DILATED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. THE PHYSICIAN ATTEMPTED TO SNARE THE STENT AND A DISSECTION OCCURRED. THE DISSECTION WAS CAUSED BY THE SNARE. PATIENT WAS SENT TO URGENT CV SURGERY DUE TO THE DISSECTION. THE DISLODGED STENT WAS REMOVED VIA OPEN HEART SURGERY. THE PATIENT HAS RECOVERED WITH NO FURTHER INJURY.

  Patient problems: Injury; Vascular Dissection

  MAUDE report 10625297 ↗
• InjurySep 3, 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 TO TREAT A LESION. CEC ADJUDICATED THAT THE PATIENT SUFFERED MYOCARDIAL INFARCTION IN THE 1ST DIAGONAL (TARGET VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 10486915 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED HAVING A RESOLUTE ONYX RX DES IMPLANTED IN THE DIAGONAL ARTERY OF THE LAD. APPROXIMATELY 2 DAYS LATER THE PATIENT REPORTED HAVING A RASH AND HIVES ON THEIR BODY. PATIENT STATES THAT LEFT ARM IS MOST AFFECTED WITH A 10 X 3 1/2 INCH RASH ON LEFT ARM, 3 SPOTS ON RIGHT ARM AND A 4 X 12 INCH RASH ON RIGHT LEG. THE PATIENT STATES RASH SEEMS TO BE SPREADING. PHYSICIAN HAS CHANGED SOME MEDICATIONS TO CHECK FOR ALLERGIC REACTION TO MEDICATIONS. PATIENTS STATES WILL PROBABLY SEE AN ALLERGIST.

  Patient problems: Rash; Reaction

  MAUDE report 10384486 ↗
• DeathFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE ONE RESOLUTE ONYX RX WAS IMPLANTED IN THE MID DIAGONAL BRANCH. THE LESION WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED WITH 90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THERE WERE NO ISSUES NOTED DURING STENT DEPLOYMENT AND THE STENT WAS FULLY EXPANDED. IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED 0-24 HOURS POST IMPLANTATION. IT IS UNKNOWN IF THE PATIENT WAS ON DAPT, HOWEVER ANGIOMAX WAS USED DURING THE PROCEDURE. THE THROMBUS WAS NOT TREATED. PATIENT DEATH OCCURRED ON THE SAME DAY DUE TO HEART FAILURE. IT IS UNKNOWN IF THE RESOLUTE ONYX DEVICE CONTRIBUTED TO PATIENT DEATH.

  Patient problems: Death; Thrombosis

  MAUDE report 9710826 ↗
• InjuryJan 22, 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 CIRCUMFLEX. CEC ADJUDICATED THAT THE PATIENT HAD NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI PERI-PCI DUE TO LABORATORY RESULTS.

  Patient problems: Myocardial Infarction

  MAUDE report 9615550 ↗
• InjuryNov 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A LESION. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS INTRODUCED TWICE. IT WAS FIRST REMOVED DUE TO FAILURE TO CROSS THE LESION. THEN IT DISLODGED FROM THE DELIVERY SYSTEM. A SNARE KIT WAS USED TO RETRIEVE THE STENT.

  Patient problems: Injury

  MAUDE report 9295678 ↗
• InjuryNov 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT PRESENTED WITH A STEMI. AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (2.25 X 12) TO TREAT A LESION AT THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY/DIAGONAL BRANCH. THE LESION EXHIBITED MILD TORTUOSITY AND SEVERE CALCIFICATION WITH 100% STENOSIS. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS CARRIED OUT PRIOR TO USE WITH NO ISSUES NOTED. A LAUNCHER GUIDE CATHETER WAS USED TO ENGAGE THE VESSEL. PRE-DILATION OF THE LAD/DIAGONAL AND RAMUS WAS CARRIED OUT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. FOLLOWING PRE-DILATION AN ATTEMPT WAS MADE TO DELIVER THE RESOLUTE ONYX STENT TO THE LAD/DIAGONAL. DURING DELIVERY TO THE LESION THE STENT DISLODGED. AN ATTEMPT WAS MADE TO ADVANCE A EUPHORA BALLOON (1.5 X 12) TO THE DISLODGED STENT HOWEVER THE EUPHORA COULD NOT BE DELIVERED. FOLLOWING ADVANCEMENT OF A THIRD GUIDEWIRE AND NON-MEDTRONIC BALLOON THE STENT WAS CRUSHED IN THE LAD/DIAGONAL A RESOLUTE ONYX RX (3.0 X 26) CORONARY DRUG ELUTING STENT WAS THEN ADVANCED TO THE RAMUS. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS CARRIED OUT PRIOR TO USE WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED

  Patient problems: Injury

  MAUDE report 9271770 ↗