Resolute Onyx™ RONYX20015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169556645), received between Apr 3, 2018 and May 9, 2023 — classified as 3 deaths, 15 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. NO DAMAGE WAS NOTED TO THE PACKAGING, THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. 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 AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT MOVED OFF THE BALLOON UPON ADVANCEMENT. IT WAS POSSIBLE TO REMOVE THE STENT AND BALLOON FROM THE PATIENT WITHOUT ISSUES. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895600 ↗
• MalfunctionFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION IN THE MID 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO. THE PATIENT IS ALIVE WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16289251 ↗
• InjurySep 28, 2022Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT STENT DELIVERY TO THE TARGET LESION WITH THE ASSISTANCE OF A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS UNSUCCESSFUL. WHEN THE STENT DELIVERY SYSTEM WAS BEING REMOVED FROM THE TARGET LESION, THE STENT CAUGHT ON THE EDGE OF THE NON-MEDTRONIC GUIDE EXTENSION CATHETER AND THE STENT DISLODGED. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND THE STENT WAS CRUSHED AGAINST THE ARTERY. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15500466 ↗
• InjurySep 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT/EMBOLIZATION OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS CRUSHED AGAINST THE VESSEL. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15401657 ↗
• MalfunctionJul 20, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A RESOLUTE ONYX CORONARY DRUG ELUTING STENT BROKE OFF DURING A CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065286 ↗
• InjuryJul 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80-90% STENOSIS LOCATED IN THE OSTIUM OF THE 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS STATED THAT THE PATIENT UNDERWENT SURGERY TO REMOVE THE DEVICE AND NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15012498 ↗
• InjuryMar 11, 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, SEVERELY CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) 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 USED DURING DELIVERY.  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. THE PHYSICIAN WAS ABLE TO GET A BALLOON INTO THE STENT IN ORDER TO DEPLOY IT. PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13733435 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT THE STENTS HAVE 100% OCCLUSION AND THE PATIENT WILL NEED A BYPASS SURGERY TO TREAT THE BLOCKED STENTS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12670602 ↗
• MalfunctionJun 9, 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. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964759 ↗
• InjuryApr 29, 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. IT WAS REPORTED THAT THE STENT WAS NOT ABLE TO BE DELIVERED TO THE LESION AND STENT DISLODGEMENT OCCURRED DURING THE ATTEMPTED REMOVAL OF THE UNDEPLOYED STENT. THE STENT REMAINED IN THE CORONARY ARTERY AND THE PATIENT WAS SENT FOR EMERGENCY OPEN HEART SURGERY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11744298 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MO DERATELY CALCIFIED LESION IN THE PROXIMAL LAD- MID DIAGONAL BRANCH WITH 99% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH TWO PREVIOUSLY DEPLOYED STENTS, A RESOLUTE ONYX STENT DEPLOYED IN THE LAD/ DIAGONAL AND A DEPLOYED STENT IN THE OSTIAL DIAGONAL. 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. THE PROCEDURE WAS COMPLETED USING BALLOONS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700895 ↗
• InjuryFeb 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 SEVERELY CALCIFIED LESION LOCATED IN THE MID 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT BUT THE STENT WAS NOT REMOVED. IT WAS STATED THAT THE UNDEPLOYED STENT WAS PLACED IN THE ACUTE MARGINAL. IT WAS NOTED THAT A GUIDE EXTENSION CATHETER WAS USED DURING THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11365188 ↗
• DeathFeb 2, 2021Device 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 SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE MID/PROXIMAL RCA. IT WAS NOTED THAT THE LESION WAS VERY SMALL AND DIFFUSE AND WAS COMPLETELY OCCLUDED (100%). THE PATIENT PRESENTED WITH CARDIAC ARREST AND WAS INTUBATED IN THE CATH LAB. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A SC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. AN ATTEMPT WAS MADE TO USE A 2.50 X 18 MM RESOLUTE ONYX HOWEVER THE DEVICE FAILED TO CROSS THE LESION. A RESOLUTE ONYX 2.00 X 15 MM WAS THEN ATTEMPTED TO BE USED HOWEVER STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS REMOVED IN ORDER TO REPOSITION AND IT WAS NOTED THAT THE STENT WAS NOT ON THE CATHETER. ANOTHER WIRE AND A NON MEDTRONIC BALLOON WAS USED AND THE STENT WAS DEPLOYED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RESOLUTE ONYX'S DEVICES, ONE WAS DEPLOYED IN THE PROXIMAL RCA AND THE OTHER WAS DEPLOYED IN-BETWEEN THE PREV

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 11265308 ↗
• InjuryJan 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID 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. 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 AND DEPLOYED IN THE MID RCA USING 1.25MM, 2.0MM AND 3.0MM BALLOONS IN THAT SEQUENCE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11206701 ↗
• MalfunctionDec 18, 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 MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT WOULD NOT ADVANCE INTO THE RCA AND THE STENT WAS PULLED BACK. IT WAS STATED THAT THE STENT GOT STRIPPED OF THE BALLOON ON REMOVAL AND DISLODGED INTO THE PARAVERTEBRAL LUMBAR ARTERY L3. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND AFTER A WHOLE BODY CT IT WAS DECIDED TO NOT REMOVE THE STENT AND FOLLOW UP WITH IT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11035808 ↗
• MalfunctionAug 24, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A MODERATE CALCIFIED, NONE TORTUOSITY LESION IN THE PROXIMAL DIAGONAL BRANCH. THERE WAS NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT DEFORMED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10441377 ↗
• InjuryJul 29, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS (ONE 2.0X15MM AND ONE 2.0 X 8MM) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE FIRST STENT (PLI 10, 2.0 X 15MM) DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT DIFFICULTY DELIVERING THE STENT OCCURRED AFTER PRE-DILATION. IT WAS STATED THAT DURING INSPECTION OF THE DEVICE AFTER REMOVAL, IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. IT WAS CONFIRMED UNDER FLUORO THAT THE STENT CAME OFF THE BALLOON AT THE EDGE OF THE GUIDE. A NON-MEDTRONIC GUIDE WAS ADVANCED AND THE STENT WAS REMOVED USING A SNARE. ADDITIONAL PRE-DILATION WAS CARRIED OUT AND ANOTHER WIRE AND GUIDELINER WERE USED. IT WAS REPORTED THAT THE SECOND RESOLUTE ONYX RX (PLI 20, 2.0 X 8MM) WAS ATTEMPTED TO BE DELIVERED BUT FAILED. ADDITIONAL PRE-DILATION WAS CARRIED OUT USING AN NC 2.0 BALLOON. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO

  Patient problems: Injury

  MAUDE report 10338009 ↗
• MalfunctionMay 29, 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, SEVERELY CALCIFIED LESION LOCATED IN THE MID OBTUSE MARGINAL (OM). 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 DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT AN ATTEMPT WAS MADE TO RECAPTURE WITH A WIRE BUT THE WIRE COULD NOT CROSS AND THE STENT COULD NOT BE RETRIEVED. THE STENT REMAINS IN THE PATIENTS OM. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10100339 ↗
• InjuryMay 20, 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 HEAVILY CALCIFIED LESION. THE LESION WAS PRE-DILATED USING A 2.0 BALLOON AND IT WAS INDICATED THAT THERE WAS DIFFICULTY PASSING THE BALLOON. IT WAS REPORTED THAT UPON ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM IN TACT, THE STENT STRIPPED FROM THE BALLOON AND REMAINED LODGED IN THE VESSEL. IT WAS STATED THAT FFRED WAS CARRIED OUT BUT IVUS WAS NOT. NO ATHRECTOMY WAS USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10074412 ↗
• MalfunctionMar 2, 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 MILDLY TORTUOUS LESION EXHIBITING 99% STENOSIS IN THE MID AND PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 DURING DELIVERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. IT WAS REPORTED THAT TWO STENTS DISLODGED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE STENT WITH LOT NUMBER 0009827011 DISLODGED IN THE PROXIMAL RCA. THIS AREA WAS ON A BEND IN THE RCA. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED FOLLOWING STENT DEPLOYMENT. IT WAS REPORTED THAT THE SECOND STENT WITH LOT NUMBER 0009936873 WAS DISLODGED AND CRUSHED AGAINST THE MID RCA. THE STENT WAS MEANT TO BE IMPLANTED IN THE DISTAL PLA BRANCH DISTALLY. IT WAS STATED THAT A BALLOON WAS USED TO CRUSH THE STENT AGAINST THE VESSEL. MULTIPLE BALLOON INFLATIONS WERE CARRIED OUT AND A FULL METAL JACKET IN THE PROXIMAL TO MID RCA. POST DILATION WAS REQUIRED. THE PATIENT WAS REPORT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9773707 ↗
• DeathFeb 6, 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 CIRCUMFLEX. APPROXIMATELY 10 MONTHS POST INDEX PROCEDURE, PATIENT HAD A SUDDEN CARDIAC DEATH SECONDARY TO VENTRICULAR FIBRILLATION. CPR WAS PERFORMED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE AND ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9675438 ↗
• MalfunctionJan 21, 2020Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE DELIVERED TO THE LESION WITH IT BEING REMOVED AND ATTEMPTED MULTIPLE TIMES, IT WAS INSPECTED AGAIN AFTER REMOVAL BEFORE EACH ATTEMPT. IT WAS NOTED THAT THE STENT WAS NOT ABLE TO BE DELIVERED TO THE LESION DUE TO DIFFICULT ANATOMY. ON THE FINAL ATTEMPT THE STENT DID CROSS THE LESION AND THE BALLOON WAS INFLATED TO DEPLOY THE STENT. THERE WERE NO INFLATION DIFFICULTIES. IT WAS REPORTED THAT UPON ITS REMOVAL THE STENT WAS STILL ON THE BALLOON AND WAS NOTED TO BE SEVERELY DEFORMED. IT IS STATED THAT IT WAS THOUGHT THE TUOHY ADAPTER WAS TOO TIGHT AND THE STENT 'ACCORDIANED' THERE. IT IS ALSO STATED THAT IT WAS THOUGHT NOT TO BE THE STENT'S FAULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9609680 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A LESION. IT IS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION.

  Patient problems: Thrombus

  MAUDE report 9600375 ↗
• MalfunctionDec 9, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL RCA. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. ANOTHER RESOLUTE ONYX RX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9435761 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE 2ND DIAGONAL GRAFT. DURING ANOTHER PROCEDURE A SECOND RESOLUTE ONYX DES WAS IMPLANTED IN THE TARGET VESSEL 2ND DIAGONAL GRAFT. APPROXIMATELY 24 MONTHS POST PROCEDURE, PATIENT DEATH WAS REPORTED. CAUSE OF DEATH IS UNKNOWN. THE INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Aneurysm; Death; Thrombus

  MAUDE report 9127594 ↗