Resolute Onyx™ RONYX22530UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169556751), received between Sep 22, 2017 and Jun 1, 2022 — classified as 3 deaths, 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2022Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID 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 FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED BY DILATION WITH A SEMI-COMPLIANT BALLOON AND A NON-MEDTRONIC STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565277 ↗
• DeathApr 13, 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 LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 THE STENT WAS NOT REMOVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR CARE. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 14102537 ↗
• MalfunctionOct 21, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE MID CIRCUMFLEX ARTERY (CX). IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE STENT HAD A KINK IN THE MIDDLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12671360 ↗
• MalfunctionJul 27, 2021Use of Device Problem; Use of Device Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED. IT WAS STATED THAT THE DEVICE WAS INSPECTED PRIOR TO USE 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. IT WAS REPORTED THAT THE STENT WAS IMPLANTED AFTER IT'S EXPIRY DATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230774 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX AND LAD. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12056238 ↗
• InjuryJun 8, 2021Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  ONE 2.25X30MM RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS STATED THAT THERE WAS MILD RESTENOSIS OF THE MID RCA STENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. A COUGAR GUIDE WIRE WAS USED. A 2.5X15MM EUPHORA BALLOON WAS USED TO PRE-DILATE THE MID RCA, DISTAL PLV AND THE OSTIUM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. A 3.5X22MMRESOLUTE ONYX STENT WAS SUCCESSFULLY DEPLOYED AT THE OSTIUM. A 2.5X20MM EUPHORA BALLOON WAS USED TO FURTHER DILATE THE DISTAL PLV. THE 2.25X30MM RESOLUTE ONYX WAS LOADED INTO THE GUIDE BUT THE GUIDE LOST POSITION AS THE STENT WAS COMING OUT. THE GUIDE WAS RE-ENGAGED IN THE OSTIUM AND IT WAS DIFFICULT TO ADVANCE THE STENT BEYOND THE RESTENOSED STENT IN THE MID RCA. THE STENT WAS PULLED BACK BUT IT DISLODGED. A BALLOON WAS UNABLE TO BE ADVANCED DISTALLY TO INFLATE AND PULL BACK THE STENT. IT WAS DECIDED TO CRUSH THE STENT AGAINST THE VESSEL

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11957425 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. IT WAS REPORTED THAT PATIENT'S CARDIAC ENZYMES WERE ELEVATED POST INDEX PROCEDURE. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI (LAD).

  Patient problems: Myocardial Infarction

  MAUDE report 10866544 ↗
• DeathSep 16, 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 TO TREAT A LESION. THERE WAS NO ISSUE REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DEFORMATION IN VIVO OCCURRED DURING POSITIONING. IT WAS STATED THAT A SMALL PERFORATION OF THE CORONARY ARTERY OCCURRED. THE PATIENT WAS REPORTED TO HAVE DECEASED.

  Patient problems: Death; Insufficient Information; Myocardial Infarction; Perforation

  MAUDE report 10541086 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE THREE RESOLUTE ONYX RX DES WAS IMPLANTED IN THE MID RCA, PROXIMAL LAD AND THE DISTAL CX. THREE DAYS POST INDEX PROCEDURE DURING THE STAGE PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE MID RCA. APPROXIMATELY 10 DAYS POST INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE DISTAL LAD. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT STARTED EXPERIENCING ACUTE ONSET CRASHING LEFT SIDED CHEST PAIN THAT RADIATED TO HIS LEFT ARM. PATIENT WAS TREATED WITH 1 NITRO AND FULL DOSE ASA AND NO RELIEF. EKG SHOWED ST ELEVATION. STENT FOR CATHETER SHOWED 100% OCCLUDED DISTAL LAD. PATIENT WILL CONTINUE ON DAPT. THE PATIENT IS RECOVERING AND WAS RELEASED FROM HOSPITAL.. THE PATIENT WAS TAKING ANTIPLATELET THERAPY WITHIN 24 HOURS PRIOR TO THE EVENT. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE MEDICATION AND POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Occlusion

  MAUDE report 10533821 ↗
• InjuryJan 30, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE 2.25X34MM RESOLUTE ONYX DRUG ELUTING STENT WAS SUCCESSFULLY IMPLANTED IN THE MID LAD ((B)(6) 2020) AT DIFFERENT FACILITY. APPROX 3 DAYS LATER ((B)(6) 2020) THE PATIENT PRESENTED WITH STEMI, AND THE LAD WAS 100% TOTALLY OCCLUDED FROM THE DISTAL LM. THERE WAS NO FLOW IN LAD AND CIRCUMFLEX AND RAMUS VESSELS. THE PATIENT WAS TAKING DAPT AS PRESCRIBED. AN ATTEMPT WAS MADE TO TREAT THE PATIENT WITH TWO RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENTS (2.25X30MM RESOLUTE ONYX, AND 3.5 X 22MM RESOLUTE ONYX). THE LESION WAS A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID, PROXIMAL LEFT MAIN (LM) CORONARY ARTERY/LEFT ANTERIOR DESCENDING (LAD) ARTERY/RAMUS BRANCH. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITHOUT ISSUES. BOTH DEVICES DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. THE LAD AND CIRCUMFLEX VESSELS WERE WIRED AND PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE 3.5 X 22MM RESOLUTE ONYX DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 2.25X30MM RESOLUTE ONYX. A RESOLUTE ONYX STENT WAS PLACED IN THE PROXIMAL CIRCUMFLEX. THE 3.5 X 22MM RESOLUTE

  Patient problems: Injury

  MAUDE report 9646384 ↗
• MalfunctionJan 30, 2020Fracture; Migration or Expulsion of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Fracture; Migration or Expulsion of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  A 2.25 X 30 RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI10) WAS USED TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOSITY LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. AN ATTEMPT WAS THEN MADE TO DELIVER A 2.25 X 38 MM RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI20) THROUGH A PROXIMAL 2.25 X 30 RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI10) TO A DISTAL LESION THE STENT COULD NOT PASS THE PROXIMAL STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE 2.25 X 38MM DEVICE (PLI20). THE 2.25 X 38MM DEVICE WAS INSPECTED WITH NO ISSUES, NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE 2.25 X 38 RESOLUTE STENT (PLI 20) DEFORMED INSIDE THE 2.25 X 30 RESOLUTE ONYX RX STENT (PLI 10). DURING REMOVAL OF THE 2.25 X 38MM DEFORMED STENT (PLI20) IT CAUGHT ON THE 2.25 X 30MM STENT (PLI10) AND THE 2.25 X 30MM STENT (PLI10) DISLODGED. BOTH STENTS WERE SNARED IN THE AORTA AND REMOVED. THE LESION WAS THEN

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9646340 ↗
• InjuryJan 24, 2020Device 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% 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 DELIVERY. IT WAS REPORTED THAT WHILE ATTEMPTING TO DELIVER THE STENT TO THE DISTAL CIRCUMFLEX ARTERY THE STENT COULD NOT PASS THE PROXIMAL BEND DUE TO ITS SEVERE ANGLE AND CALCIFICATION. WHILE ATTEMPTING TO WITHDRAW THE STENT INTO THE GUIDE CATHETER, STENT DISLODGEMENT OCCURRED AT THE OSTIUM OF THECX ARTERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. BALLOON ANGIOPLASTY WAS THEN PERFORMED TO THE DISTAL TARGET LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9626922 ↗
• MalfunctionNov 27, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED RESOLUTE ONYX RX CORONARY DES WAS IMPLANTED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID DIAGONAL BRANCH WITH 70% STENOSIS. 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. THERE WERE NO FURTHER ISSUES APART FROM THE IMPLANTATION OF THE EXPIRED DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382479 ↗
• InjuryNov 4, 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 STENT WAS USED TO TREAT THE LAD. IT WAS REPORTED THAT AN ABRUPT CLOSURE WAS NOTED IN THE 2ND DIAGONAL DURING INDEX PROCEDURE. SAFETY ADJUDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE DEVICE AND THE PROCEDURE BUT WAS NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 9271380 ↗
• DeathSep 12, 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 IMPLANTED IN THE LAD. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CARDIAC ARREST AND DIED. CAUSE OF DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. THE CAUSE OF DEATH WAS CARDIAC ARREST DUE TO ATHEROSCLEROTIC HEART DISEASE, CONGESTIVE HEART FAILURE AND HYPERTENSION. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI PLATELETS. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND ANTI PLATELETS.

  Patient problems: Death

  MAUDE report 9008828 ↗
• MalfunctionSep 4, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND THE STENT WAS DEFORMED WITH STRUT OF THE STENT STICKING OUT. NO PATIENT INJURY REPORTED. ANOTHER ONYX DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959727 ↗
• InjuryJul 8, 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 LAD. DISSECTION WAS OBSERVED. THE PATIENT WAS TREATED WITH IMPLANTATION OF ANOTHER RESOLUTE ONYX STENT INTO THE LAD.

  Patient problems: Intimal Dissection

  MAUDE report 8766792 ↗
• MalfunctionApr 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE RAMUS WITH 100% CTO. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 AFTER REMOVAL FROM THE PATIENT. IT WAS INDICTED THAT THE STENT WAS TOO LONG AND A DIFFERENT SIZE STENT WAS PREFERRED. THE STENT WAS THEREFORE REMOVED AND ON REMOVAL THE STENT FELT LOOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527528 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. APPROX 1.5 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN NSTEMI. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8381643 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDICATIONS INCLUDED NON-ST ELEVATION AND NON-ACUTE MI. THE PATIENT WAS IN A STATE OF HEART FAILURE WITHIN TWO WEEKS OF THE INITIAL PROCEDURE. FIVE RESOLUTE ONYX DRUG ELUTING STENT DEVICES WERE USED TO TREAT MILDLY TORTUOUS, MODERATELY CALCIFIED LESIONS IN THE PROXIMAL RCA AND MID CIRCUMFLEX ARTERY ((B)(6) 2018). THERE WAS 90% STENOSIS IN THE PROX RCA, 80% STENOSIS IN THE MID RCA, 90% IN THE MID CIRCUMFLEX AND 70% IN THE PROXIMAL CIRCUMFLEX, AND UP TO 99% STENOSIS IN THE DISTAL LAD. THE MID CX LESION SHOWED EVIDENCE OF THROMBUS PRESENCE AND RUPTURED PLAQUE. THE PROCEDURE WAS URGENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED. THERE IS NO ALLEGED PRODUCT ISSUE. ONE 3.5X30MM RESOLUTE ONYX STENT, AND ONE NC EUPHORA BALLOON WERE SUCCESSFULLY IMPLANTED IN THE MID CX AT 14 ATM. ONE 4.0X12MM RESOLUTE ONYX STENT WAS SUCCESSFULLY IMPLANTED IN THE PROX CX AT 16 ATM.

  Patient problems: Death; Occlusion; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7555869 ↗
• InjuryApr 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION, LOCATED IN THE MID DIAGONAL BRANCH, EXHIBITING 100% STENOSIS (CTO). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THERE WERE NO DIFFICULTIES REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THERE WAS NO ISSUE WITH THE INFLATION DEVICE. THE DEVICE DID 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WENT OVER A BEND AND WHEN IT WAS BACKED UP, THE STENT DISLODGED, AND A NON-COMPLIANT POST DILATION BALLOON WAS THEN USED TO FULLY EXPAND THE STENT TO THE VESSEL WALL. THE STENT WAS NOT CRUSHED. THE PROCEDURE WAS COMPLETED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7410610 ↗
• MalfunctionApr 9, 2018Fracture; Material Deformation; Fracture; Material Deformation

  DURING THE PROCEDURE, A RESOLUTE ONYX RX DRUG ELUTING STENT WAS USED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL CIRCUMFLEX ARTERY, EXHIBITING 80% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED 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 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 STRUT FRACTURED AND WAS STICKING STRAIGHT UP MID STENT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406930 ↗
• MalfunctionFeb 20, 2018Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION. THE STENT WAS INSPECTED AFTER REMOVAL FROM HOOP WITH NO KNOWN DAMAGE. THE DEVICE FAILED TO CROSS THE INTENDED LESION AND UPON REMOVAL OF DEVICE FROM PATIENT STENT DAMAGE WAS NOTED. IT IS REPORTED THAT THE DAMAGE WAS CAUSED BY THE CALCIFIC LESION. AN ATTEMPT WAS MADE TO CROSS THE LESION WITH TWO DIFFERENT MANUFACTURERS STENT, HOWEVER, THE PROCEDURE COULD ONLY BE COMPLETED BY BALLOONING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281874 ↗
• MalfunctionFeb 19, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION LOCATED AT THE DISTAL RIGHT CORONARY ARTERY WHICH HAD MODERATE TORTUOSITY AND MILD CALCIFICATION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING/ADVANCEMENT. IT WAS REPORTED THAT THE STENT STRUTS WERE DAMAGED. IT WAS INFORMED THAT THE PHYSICIAN COMPLETE THE PROCEDURE USING A 2.5X18 NON-MEDTRONIC DEVICE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7279649 ↗
• InjuryOct 17, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED RAMUS OSTIAL PROXIMAL LESION WITH CHRONIC TOTAL OCCLUSION, MODERATE TORTUOSITY AND SEVERE CALCIFICATION THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED POST REMOVAL OF THE SHEATH WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. IT IS REPORTED THAT THE STENT ORIGINALLY CROSSED THE LESION SUCCESSFULLY BUT HAD TO BE REMOVED DUE TO LOSS OF IMAGING. THE PHYSICIAN DID NOT FEEL COMFORTABLE LEAVING THE STENT IN POSITION WHILE THE X-RAY REBOOTED SO HE PULLED THE STENT BACK. AFTER THE POWER HAD RESTORED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT AND NOTED THAT THE STENT HAD DISLODGED FROM THE DELIVERY SYSTEM. SEVERAL ATTEMPTS WERE MADE TO RECAPTURE THE STENT BUT WERE UNS

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6954033 ↗