Resolute Onyx™ RONYX27522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169556911), received between Oct 9, 2017 and Dec 7, 2022 — classified as 1 death, 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• DeathDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE CX. ONE NC EUPHORA BALLOON AND TWO EUPHORA RX BALLOONS WERE ALSO USED DURING THE PROCEDURE. APPROXIMATELY 25 MONTHS POST PROCEDURE PATIENT DIED FROM AN UNKNOWN CAUSE AFTER BEING DIAGNOSED WITH LUNG CANCER ON THE 24 MONTH FOLLOW UP VISIT. THE DEATH CLASSIFIED WAS CLASSIFIED AS UNKNOWN. THE CEC ADJUDICATED THE EVENT AS A CARDIAC DEATH. THE CEC COMMENTED THAT THEIR ADJUDICATION IS BASED ON THE WORST CASE SCENARIO AS THERE IS NO SOURCE DOCUMENT ABOUT THE CIRCUMSTANCES OF DEATH.

  Patient problems: Cancer; Insufficient Information

  MAUDE report 15930263 ↗
• MalfunctionJul 12, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS STATED THAT THE STENT WAS BENT DUE TO CALCIUM. THE STENT WAS UNABLE TO BE USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986644 ↗
• InjuryMar 24, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13888195 ↗
• InjuryFeb 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS. 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 THE STENT DISLODGED DURING DELIVERY TO THE LESION. ANOTHER BALLOON WAS THREADED INTO THE STENT AND INFLATED TO DEPLOY THE STENT. A SECOND LARGER 2.75MM BALLOON WAS THEN USED TO POST-DILATE THE STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13590791 ↗
• InjuryJun 29, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE DEVICE EASILY PASSED MID PORTION OF RCA BUT WOULDN¿T DELIVER DISTAL TO THE LESION. A GUIDELINER WAS THEN USED TO DELIVER THE STENT. THE DEVICE WAS PULLED BACK AND RESISTANCE WAS FELT. IT WAS NOTED THAT THERE WAS NO STENT ON BALLOON AND THAT THE PROXIMAL EDGE OF THE STENT WAS SOMEWHAT OPENED. AS THE GUIDEWIRE WAS STILL IN THE PATIENT, THE PHYSICIAN WAS ABLE TO BALLOON WITH A 1.2MM BALLOON AT PROXIMAL PART OF THE STENT BUT WASN¿T ABLE TO GET IT FULLY BALLOONED AS THE BALLOON WOULD NOT ADVANCE. AN ATTEMPT TO USE A NON-MEDTRONIC MICROCATHETER WAS ALSO PERFORMED WITH NO SUCCESS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12082578 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED WHEN ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER. THE DETACHED PORTION WAS REMOVED BY PULLING IT OUT THROUGH THE GUIDE CATHETER BY HAND. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11929735 ↗
• MalfunctionMar 8, 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 EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THE STENT WAS NOT REMOVED AND WAS EXPANDED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435390 ↗
• InjuryDec 9, 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 IMPLANTED IN THE LAD. A DISSECTION OCCURRED DURING PROCEDURE. APPROXIMATELY 19 MONTHS POST PROCEDURE, PATIENT SUFFERED GASTROINTESTINAL BLEED AND WAS HOSPITALIZED. PATIENT WAS ON DAPT WITHIN 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED EVENT AS NOT RELATED TO THE STUDY DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO STUDY DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10980073 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 10 MONTHS POST PROCEDURE, PATIENT UNDERWENT PCI OF A CHRONIC TOTAL OCCLUSION OF RCA. VESSELS TREATED WERE; 1ST RPL, R-PDA AND RCA. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 9636472 ↗
• InjuryDec 19, 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 10 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (VESSEL UNKNOWN) AND SEVERE CORONARY STENOSIS/ PROGRESSION OF CAD. 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 BUT NOT RELATED TO ANTI-PLATELET MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction; Stenosis

  MAUDE report 9494055 ↗
• 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: THREE IN THE RCA AND ONE IN THE CX. POST PROCEDURE SIDE BRANCH OCCLUSION OF THE 2ND OM WAS NOTED THROUGH ANGIOGRAPHY.

  Patient problems: Occlusion

  MAUDE report 9144320 ↗
• MalfunctionSep 24, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A MILDLY CALCIFIED, NON TORTUOUS LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WAS NO DAMAGED NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING FROM THE HOOP. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS NOT PERFORMED. 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 IMPLANTED WAS EXPIRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9109206 ↗
• MalfunctionMay 27, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A CORONARY LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8644122 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD AND 1ST OBTUSE MARGINAL. THE RCA WAS ATTEMPTED TO BE TREATED BUT ABANDONED DUE TO DISSECTION. THE FOLLOWING DAY, THE PATIENT SUFFERED ELEVATED TROPONIN. THE PATIENT IS NOT RECOVERED. THE INVESTIGATOR ASSESSED THAT THE EVENT IS NOT RELATED TO DEVICE OR ANTIPLATELET MEDICATION. CEC ADJUDICATED THAT THE EVENT IS A Q-WAVE MYOCARDIAL INFARCTION OF THE TARGET VESSEL (RCA) 3RD UDMI PERI-PCI. THERE WAS SLOW FLOW IN THE RCA BUT NOT STENT THROMBOSIS.

  Patient problems: Myocardial Infarction

  MAUDE report 8635437 ↗
• InjuryFeb 27, 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 AND THREE RESOLUTE ONYX STENT WERE IMPLANTED INTO THE LCX. ONE DAY POST PROCEDURE THE PATIENTS CARDIAC ENZYMES WERE ELEVATED. CEC ASSESSED THE EVENT AS NON Q WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8372957 ↗
• InjuryFeb 13, 2019Adverse 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 LAD. POST-PROCEDURE, SUBJECT¿S TROPONIN PEAKED AT 0.26 NG/ML, 4.33URL. CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL LAD), MDT EXTENDED HISTORICAL PERI-PCI AND ADJUDICATED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8334386 ↗
• MalfunctionNov 7, 2018Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE PROXIMAL RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 ENCOUNTERED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION, A GUIDE LINER WAS THEN USED HOWEVER THE DEVICE STILL COULD NOT ADVANCE ACROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THERE WAS A STENT STRUT LIFTED ON THE PROXIMAL SEGMENT OF THE STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8045683 ↗
• MalfunctionSep 26, 2018Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS (RONYX27522UX) AND (RONYX25012UX) WERE IMPLANTED IN THE OSTIUM /PROXIMAL OF THE RAMUS. THE LESION EXHIBITED MILD TORTUOSITY, MILD CALCIFICATION AND 100% ACUTE STENOSIS. ARTERY DIAMETER 2.75 X18MM. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE PRODUCTS WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. DURING HOSPITALIZATION A VESSEL OCCLUSION DUE TO ACUTE STENT THROMBOSIS OCCURRED ALONG WITH A TARGET VESSEL MYOCARDIAL INFARCTION (1 DAY POST PROCEDURE). PATIENT EXPIRED (B)(6) 2018.

  Patient problems: Cardiac Arrest; Death; Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7908966 ↗
• MalfunctionAug 3, 2018Break; Material Deformation; Material Deformation

  INFORMATION RECEIVED FROM THE ACCOUNT ON A NO CROSS FORM STATED THAT THE RESOLUTE ONYX DEVICE WAS DAMAGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7746685 ↗
• MalfunctionJul 4, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE A NON-MEDTRONIC BALLOON WAS USED TO PRE-DILATE THE LESION. IT WAS REPORTED THAT ONE RESOLUTE ONYX RX DRUG ELUTING STENT FAILED TO CROSS THE LESION AND WHEN REMOVED THE STENT WAS DEFORMED. IT WAS INFORMED THAT BENT STRUTS WERE NOTED. THE RESOLUTE ONYX WAS INSPECTED PRIOR TO USE, WITH NO ISSUES NOTED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662381 ↗
• InjuryMay 23, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WAS 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE 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. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED AND PRE-TREATED WITH ROTABLATOR. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY THE STENT DISLODGED JUST DISTAL TO THE NON-MEDTRONIC GUIDE CATHETER. THE LESION WAS DESCRIBED AS BEING A "TOUGH" CALCIFIED LESION. THE DISLODGED STENT WAS COMPRESSED AGAINST THE GUIDE CATHETER, WHEN WITHDRAWING THE DELIVERY SYSTEM AFTER THE DEVICE DID NOT CROSS LESION. THE DISLODGED STENT WAS THEN REMOVED FROM THE PATIENT USING A SNARE. THE PROCEDURE WAS COMPLETED USING 2.5X15MM, 2.75X26MM, 3.0X18MM AN

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7536518 ↗
• MalfunctionMar 27, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY, EXHIBITING 90% 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS PLACED THROUGH THE GUIDE LINER AND PHYSICIAN FELT RESISTANCE AS THE STENT WAS PASSING THROUGH THE CALCIFIED LESION. PHYSICIAN DECIDED TO TAKE THE STENT OUT AND THEY NOTICED THAT THE STENT WAS DAMAGED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372598 ↗
• MalfunctionFeb 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY WITHIN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED AND REMAINS IN THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7285462 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE PATIENT PRESENTED AN ACUTE THROMBOSIS POST STENT DEPLOYMENT WITHIN 0 TO 6 HOURS REQUIRING IMMEDIATE INTERVENTION. PATIENT STATUS IS ALIVE.

  Patient problems: Thrombus

  MAUDE report 6928018 ↗