Resolute Onyx™ RONYX35026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169557109), received between Aug 10, 2017 and Nov 2, 2022 — classified as 2 deaths, 15 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714029 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED AFTER THE STENT PROCEDURES AND THE PATIENT EXPERIENCED AN ITCHY RASH ALL OVER. THE PATIENT HAS BEEN TO AN ALLERGIST FOR TESTING AND HAD MEDICATIONS STOPPED, HOWEVER THE PATIENT STILL HAS THE RASH. STEROIDS WERE ALSO PRESCRIBED WHICH HELPED FOR A SHORT PERIOD OF TIME, HOWEVER THE RASH AND ITCHING HAS NOT GONE AWAY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 15585519 ↗
• InjuryOct 4, 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 NON-TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING A 2.5X15MM NON-MEDTRONIC BALLOON. 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 WAS ADVANCED AND PULLED BACK MULTIPLE TIMES. THE DISLODGED STENT WAS REMOVED USING A 7F SNARE. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15537649 ↗
• MalfunctionAug 5, 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. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON EITHER DEVICE. 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 BOTH STENTS DEFORMED IN VIVO WITH STRUTS RAISED DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174023 ↗
• MalfunctionJun 9, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT MILDLY TORTUOUS, MODERATELY CALCIFIED EXHIBITING 80% STENOSIS LOCATED 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. 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/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC 3.5 X 23MM STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641856 ↗
• InjuryNov 29, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT, A TELESCOPE GUIDE EXTENSION CATHETER AND A LAUNCHER GUIDE CATHETER IN A MILDLY CALCIFIED, MILDLY TORTUOUS LESION, WITH 80% STENOSIS, LOCATED IN THE PROXIMAL OBTUSE MARGINAL (OM) ARTERY. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP PERFORMED WAS PERFORMED ON THE STENT WITH NO ISSUES. THE TELESCOPE AND LAUNCHER WERE PREPPED PER IFU, WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE RESOLUTE ONYX STENT DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY AND ENDED UP IN THE ULNAR ARTERY. IT WAS SUGGESTED THAT THE STENT WAS DEFORMED AS A RESULT OF TRYING TO RETURN THROUGH THE TIP OF TELESCOPE CAUSING THE STENT TO BE DISLODGED FROM THE BALLOON. THE DEVICE WAS REMOVED USING A SNARE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12882362 ↗
• MalfunctionNov 3, 2021Difficult to Remove; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS TO TREAT A LESION IN THE MID RCA AND THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED FOLLOWING STENT DEPLOYMENT. IT WAS ALSO REPORTED THAT THE CATHETER/DELIVERY SYSTEM OF THE FIRST RESOLUTE ONYX STENT WAS DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743701 ↗
• 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 12680347 ↗
• InjuryMay 12, 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, MILDLY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). 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 NOT 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 THAT THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11812171 ↗
• MalfunctionMay 11, 2021Inflation Problem; Device Dislodged or Dislocated; Material Deformation; Inflation Problem; 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 MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE MID RCA WITH 90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED AT 14-16 ATMS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804796 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. DURING A STAGED PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. APPROXIMATELY 16 MONTHS POST INDEX AND STAGED PROCEDURES THE PATIENT SUFFERED FROM CHEST DISCOMFORT. IT WAS REPORTED THAT A SCAR WAS OBSERVED IN THE AREA OF THE STENT, LIKELY A JAILED SEPTAL IN THE MID ANTERIOR LATERAL WALL. PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS NOT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11385185 ↗
• MalfunctionFeb 15, 2021Migration or Expulsion of Device; Malposition of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Malposition of Device; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. IT WAS REPORTED THAT THE STENT DISLODGED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 11327158 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES, TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE USED TO TREAT THE RCA. APPROXIMATELY 20 DAYS LATER, DURING A STAGED PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE LAD. THE SAME DAY POST STAGED PROCEDURE PATIENT SUFFERED ELEVATED TROPONIN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THEINDEX DEVICE AND NOT TO THE ANTI-PLATELET MEDICATION AND THE PATIENT RECOVERED. CEC ADJUDICATED THAT THE PATIENT THAT APPROXIMATELY 20 DAYS POST STAGE PROCEDURE, PATIENT SUFFERED A TARGET VESSEL MYOCARDIAL INFARCTION INVOLVING THE LAD.

  Patient problems: Myocardial Infarction

  MAUDE report 10883689 ↗
• MalfunctionOct 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A LESION, IT WAS REPORTED THAT THE STENT STRIPPED OFF THE BALLOON WHEN THE STENT WAS ADVANCING THROUGH THE GUIDE LINER. THE STENT REMAINED CRIMPED ONTO THE BALLOON AND WAS ABLE TO BE REMOVED FROM THE PATIENT¿S BODY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10668833 ↗
• MalfunctionJun 8, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A DISTAL SVG . IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN THE DEVICE WAS REMOVED THE STENT WAS DAMAGED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10128135 ↗
• InjuryMay 27, 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 RIGHT CORONARY ARTERY (RCA). 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. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE DEVICE AND A DESTINATION CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 10090989 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD DURING STAGED PROCEDURE. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ATYPICAL CHEST PAIN. EVENT WAS TREATED WITH MEDICATION. CEC AND SAFETY ADJUDICATED THE EVENT AS NON-Q-WAVE MI, 3RD UDMI SPONTANEOUS(VESSEL UNKNOWN). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9260214 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD DURING STAGED PROCEDURE. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ATYPICAL CHEST PAIN. EVENT WAS TREATED WITH MEDICATION. CEC AND SAFETY ADJUDICATED THE EVENT AS NON-Q-WAVE MI, 3RD UDMI SPONTANEOUS (VESSEL UNKNOWN). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9260201 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD, R-PDA AND RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE BLOOD LOSS ANEMIA SECONDARY TO PREPYLORIC ULCER. EVENT WAS TREATED WITH BLOOD TRANSFUSION AND ME DICATION. PATIENT WAS ON DAPT WITHIN 24 HOURS PRIOR TO EVENT. SPONSOR ASSESSED EVENT AS NOT RELATED TO DEVICE BUT POSSIBLY RELATED ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9144272 ↗
• MalfunctionAug 6, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING, THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. IT WAS REPORTED THAT STENT FAILED TO CROSS AND DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864719 ↗
• InjuryJul 29, 2019Adverse 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. APPROX 7 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CARDIAC CHEST PAIN. THE PATIENT WAS TREATED WITH STENTING TO TREAT STENT THROMBOSIS IN THE RCA. THE PATIENT WAS ALSO TREATED WITH A MEDICATION CHANGE. THE PATIENT WAS NOT ON DAPT AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE STENT INVOLVED WAS RESOLUTE ONYX LOT: 0008847456. THE PATIENT IS RECOVERING.

  Patient problems: Injury; Stenosis; Thrombus

  MAUDE report 8836692 ↗
• MalfunctionMay 29, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 95% 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 NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT FAILED TO CROSS THE LESION DUE TO CALCIFICATION. THE DEVICE WAS REMOVED FROM THE PATIENT AND UPON INSPECTION STENT DEFORMATION WAS NOTED WITH A STRUT OF THE STENT NOTED TO BE LIFTED. THE PROCEDURE WAS COMPLETED BY PRE-DILATING THE LESION WITH A LARGE SC BALLOON AND ANOTHER 3.5X26MM RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650160 ↗
• MalfunctionJul 4, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ONE RESOLUTE ONYX DRUG-ELUTING STENT WAS USED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND MODERATE CALCIFICATION EXHIBITING 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO PATIENT'S ANATOMY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE LEAK. IT WAS REPORTED THAT AFTER THE STENT WAS PASSED THROUGH THE LESION, AN INFLATION AT 12ATM WAS ATTEMPTED BUT ONLY THE PROXIMAL AND DISTAL ENDS OF THE STENT INFLATED. THIS CAUSED THE STENT TO BE PARTIALLY DEPLOYED AT EITHER END AND NOT IN THE MIDDLE OF THE STENT. A SECOND INFLATION AT 18ATM WAS ATTEMPTED AND THE STENT WAS FULLY DEPLOYED. IT WAS NOTED THAT PRESSURE WAS LOST IN THE INFLATOR INDICATING A LEAK. THE PROCEDURE WAS COMPLETED WITH THIS STENT. THE PATIENT IS ALIVE WITH NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7661896 ↗
• MalfunctionMay 28, 2018Difficult or Delayed Positioning; Inflation Problem; Leak/Splash; Difficult or Delayed Positioning; Inflation Problem; Leak/Splash

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 70% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON HAD A LEAK, AND WOULD NOT FULLY INFLATE DURING THE FIRST INFLATION ATTEMPT TO DEPLOY THE STENT. IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ALSO ENCOUNTERED. QUICK INFLATION WAS PERFORMED, ENOUGH TO DEPLOY THE STENT. THE STENT WAS EXPANDED ENOUGH TO REMOVE THE BALLOON. POST DILATATION WAS PERFORMED WITH A NON-COMPLIANT BALLOON WITH GOOD RESULT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547734 ↗
• DeathMar 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A 3.5 X 26 MM RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE, TO TREAT A LESION LOCATED IN THE MID/DISTAL RCA, EXHIBITING MODERATE TORTUOSITY AND NO CALCIFICATION. INITIAL IMAGES REVEALED IN-STENT RE-STENOSIS WAS PRESENT IN THE MID/DISTAL RCA. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NO DIFFICULTIES WERE NOTED WHILE REMOVING THE PROTECTIVE SHEATH ON THE INITIAL INTRODUCTION OF THE PRODUCT, AND THE STENT WAS INSPECTED POST-REMOVAL OF THE SHEATH. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE REMAINED ON NEUTRAL PRESSURE DURING THE DELIVERY OF THE DEVICE. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT-THERE WERE MULTIPLE PREVIOUSLY DEPLOYED STENTS IN PLACE FROM THE PROXIMAL RCA THOUGH MID/DISTAL RCA. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL, FOLLOWING A FAILED DELIVERY. PREVIOUSLY TO THE DISLODGEMENT, THE PHYSICIAN HAD GONE IN WITH THE 3.5 X 26 MM RESOLUTE ONYX DRUG ELUTING STENT PRIO

  Patient problems: Death; Heart Failure; Patient Problem/Medical Problem

  MAUDE report 7352723 ↗