Resolute Onyx™ RONYX27508UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169556874), received between Jun 26, 2017 and Jun 24, 2025 — classified as 1 death, 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2025Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO OR AT THE LESION. THERE WAS SEVERE TORTUOSITY AND SEVERE CALCIFICATION IN THE MID SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY.  THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317557 ↗
• MalfunctionNov 11, 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 DES TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE CX ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. ON ATTEMPTING TO REMOVE THE DEVICE AFTER A FAILED DELIVERY THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS REMOVED USING THE DELIVERY BALLOON. A NON MEDTRONIC STENT WAS USED IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE FINE AND THE PROCEDURE COMPLETED.

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

  MAUDE report 10821690 ↗
• MalfunctionMar 10, 2020Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS EXPIRED AT THE TIME OF IMPLANT BY ONE MONTH. THE STENT REMAINS IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9810278 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, 5 RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; THREE IN THE RCA AND TWO IN THE LAD. THE FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES WITH NO TREATMENT CARRIED OUT. PATIENT RECOVERED. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI PCI. CEC ASSESSMENT COMMENTED THAT THERE WAS A LARGE SIDE BRANCH OCCLUSION. INVESTIGATOR ASSESSED THE EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9552195 ↗
• MalfunctionDec 16, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY CALCIFIED LESION IN THE CIRCUMFLEX ARTERY. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE DUE TO CALCIUM. MULTIPLE ATTEMPTS WERE MADE TO TRY TO GET THE DEVICE TO ADVANCE. IT WAS STATED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS ALSO STATED THAT THE DEVICE WAS REMOVED AFTER A FAILED DELIVERY, THE DEVICE WAS ATTEMPTED TO BE RE-LOADED ON THE WIRE WHEN DEFORMED STRUTS WERE NOTICED. THE LESION WAS THEN PREDILATED WITH A EUPHORA BALLOON CATHETER AND AN NON MEDTRONIC STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9473823 ↗
• MalfunctionSep 4, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING FROM THE HOOP. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT POST IMPLANTATION OF THE STENT, IT WAS NOTED TO HAVE EXPIRED FOUR DAYS PREVIOUS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. (QUARTERLY SCAN WAS PERFORMED LAST QUARTER AND WAS SCHEDULED FOR NEXT WEEK FOR Q2. ACCOUNT INVENTORY PERSONNEL ASKS THAT PRODUCT NOT BE PULLED FROM SHELF DURING QUARTERLY SCANS UNLESS LESS THAN 30 DAYS IS LEFT UNTIL USE BY DATE. ACCOUNT INVENTORY PERSONNEL HAS VOICED THAT HOSPITAL STAFF PULLS PRODUCTS ON A CONSISTENT BASIS TO RETURN TO VENDORS FOR REPLACEMENT. ACCORDING TO THE OHSU DIRECTOR OF OPERATIONS AND FINANCE, THE PATIENT WILL NOT BE CHARGED FOR THE STENT. ACCOUNT HAS LIMITED LAB ACCESS FOR VENDORS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959286 ↗
• InjuryMay 9, 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 21 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH BLOOD PER RECTUM. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 8594778 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE TWO RESOLUTE ONYX CORONARY DES WERE IMPLANTED IN THE LAD. APPROX TEN DAYS LATER THE PATIENT SUFFERED UPPER GI BLEED REPORTED AS MOST LIKELY SECONDARY TO KNOWN HIATAL HERNIA AND CAMERON EROSIONS IN THE SETTING OF DUAL ANTIPLATELET THERAPY. PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE PATIENT WAS TREATED WITH MEDICATION. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION. PATIENT RECOVERED. (UPDATES 02/05 -APR-19 REVIEWED).

  Patient problems: Blood Loss

  MAUDE report 8564386 ↗
• InjuryMar 11, 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 2ND DIAGONAL. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED NSTEMI AND WAS TREATED WITH A PCI. IT IS REPORTED THAT THE NON STEMI WAS NOT RELATED TO THE TARGET VESSEL. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO THE STUDY DEVICE. CEC ASSESSED THE EVENT AS A NON Q WAVE MI (VESSEL UNKNOWN), MDT EXTENDED HISTORICAL SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 8408364 ↗
• InjuryMar 11, 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 2ND DIAGONAL. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED NSTEMI AND WAS TREATED WITH A PCI. IT IS REPORTED THAT THE NON STEMI WAS NOT RELATED TO THE TARGET VESSEL. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO THE STUDY DEVICE. CEC ASSESSED THE EVENT AS A NON Q WAVE MI (VESSEL UNKNOWN), MDT EXTENDED HISTORICAL SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 8408354 ↗
• InjuryNov 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE OSTIUM CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING THE REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8050425 ↗
• InjuryOct 4, 2018Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove; Activation, Positioning or Separation Problem; Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO TREAT A SEVERELY CALCIFIED, HIGHLY COMPLEX LESION IN THE CIRCUMFLEX. THE CIRCUMFLEX HAD 99% MID STENOSIS, 50% DISTAL STENOSIS AND WAS HEAVILY CALCIFIED. THE LESION WAS NOT PRE-DILATED. A RESOLUTE ONYX DRUG ELUTING STENT WAS ADVANCED HOWEVER IT WAS DIFFICULT TO CROSS THE CIRCUMFLEX LESION. THE RESOLUTE ONYX WAS DELIVERED A LITTLE PAST TARGET. AN UNSUCCESSFUL MADE TO PULL IT BACK TO THE INTENDED SITE, BUT IT COULD NOT BE PULLED BACK AS IT APPEARED STUCK ON CALCIUM. THE RESOLUTE ONYX WAS DEPLOYED IN SITU WITHOUT ANY PROBLEM. THERE WAS 95% LESION COVERAGE. A SECOND RESOLUTE ONYX WAS THEN USED. IT WAS INTENDED TO COVER THE PROXIMAL SEGMENT OF THE LESION. THIS DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED DURING INSERTION. 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. THE SAME NON-MEDTRONIC INFLATION DEVICE WAS USED FOR THE SECOND RESOLUTE ONYX STENT. THE STENT PASSED OVERLAPPING TO THE PROXIMAL EDGE. IT WAS REPORTED BALLOON INFLATION ISSUES OCCURRED. THE PROX

  Patient problems: Thrombus

  MAUDE report 7933022 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A TOTAL OF THREE RESOLUTE ONYX DRUG ELUTING STENT WERE USED TO TREAT A NON- TORTUOUS AND MODERATELY CALCIFIED LESION, LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESIONS WERE PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. ONE 2.75X12MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE STENT WAS POST DILATED TO 20 ATM. ONE 2.75X8MM RESOLUTE ONYX WAS IMPLANTED AT THE OSTIUM OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE STENT WAS POST DILATED TO 18ATM. ONE 2.75X12MM RESOLUTE ONYX WAS IMPLANTED IN THE PROXIMAL SUBSECTION OF THE PROX LAD, ONE INFLATION TO MAX PRESSURE 18ATM. THE BALLOON OF THE 2.75X8MM RESOLUTE ONYX, AND A NON-MEDTRONIC BALLOON WERE USED TO POST DILATE

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7556731 ↗
• InjuryMar 22, 2018Material Deformation; Material Deformation

  A 2.75 X 8MM RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A NON-CALCIFIED LESION IN THE OSTIUM OF THE LIMA GRAFT. TORTUOSITY WAS MILD. THE LESION HAD 60% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING. THE LESION WAS PRE-DILATED WITH A 2.25 X 8MM NON-MDT BALLOON. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE RESOLUTE ONYX STENT WAS INFLATED ONCE TO 14 ATM FOR 26 SECS. THE STENT WAS POSTDILATED WITH A 3.0 X 8MM NON-MDT NC BALLOON THREE TIMES AT 16 ATM AND 20 ATM. POST DEPLOYMENT, STENT DEFORMATION WAS NOTED ON THE RIGHT SIDE OF THE STENT NOT FAR FROM PROXIMAL EDGE OF STENT. WHILE ADVANCING THE NON-MDT GUIDE CATHETER, THE GUIDE ENGAGED THE STENT AT THE PROXIMAL EDGE ON THE LEFT SIDE OF THE STENT, AND POT ENTIALLY DEFORMED THE LEFT SIDE OF THE STENT IN SAME AREA NEAR PROXIMAL EDGE. IVUS REVEALED POSSIBLE GAPS IN STRUT COVERAGE OF LESION. TO FIX THE DEFORMATION, A 3.0 X 8MM NON-MDT STENT WAS ADVANCED. THIS APPEARED TO IMPROVE THE APPEARANCE OF STENT COVERAGE, ALTHOUGH ONE SIDE OF

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7360941 ↗
• InjuryFeb 6, 2018Adverse 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 4 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED CARDIOVASCULAR ACCIDENT (STROKE). EVENT NOT RESOLVED. INVESTIGATOR ASSESSED THAT EVENT IS NOT RELATED TO STUDY DEVICE AND ANTIPLATELET.

  Patient problems: Stroke/CVA

  MAUDE report 7243370 ↗
• MalfunctionJan 9, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT AN OSTIUM RCA. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES 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 NOT PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. DURING THE FIRST INFLATION, INFLATION DIFFICULTIES WERE REPORTED DURING STENT DEPLOYMENT AT 14ATM; THE DEVICE WOULD NOT HOLD INFLATION. NO INTERVENTION WAS REQUIRED TO REMOVE THE UNDEPLOYED RESOLUTE ONYX STENT. THE INFLATION DEVICE WAS SUCCESSFULLY USED WITH ANOTHER DEVICE POST INFLATION DIFFICULTIES. THE PATIENT WAS THEN TREATED WITH MULTIPLE RESOLUTE ONYX STENTS IN RCA, IN ORDER TO STABILIZE THEM AND TRANSFER THEM TO ANOTHER HOSPITAL FOR CABG. A TOTAL OF THREE STENTS WERE IMPLANTED, WITHOUT ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7174734 ↗
• MalfunctionJan 3, 2018Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL CIRCUMFLEX ARTERY, EXHIBITING 86% STENOSIS. 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 AND 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 AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO ADVANCE THE STENT BUT IT WOULD NOT DELIVER AFTER PRE-DILATION, ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR) AND USE OF A NON MEDTRONIC GUIDE EXTENSION CATHETER. IT WAS REPORTED THAT TOO MUCH CALCIUM WAS PRESENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING . A RONYX27508UX WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159571 ↗
• DeathDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY UNSTABLE ANGINA. DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE 1ST DIAGONAL. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPAIR AND ASD CLOSURE. THIS WAS TREATED WITH MEDICATION. THE PATIENT DIED FROM A NON SUDDEN CARDIAC DEATH. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE.

  Patient problems: Death; Thrombus

  MAUDE report 7127952 ↗
• 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 6928017 ↗
• InjuryAug 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OM. DURING STENTING OF THE LAD THERE WAS ACUTE CLOSURE OF 2.5 MM SIDE BRANCH OF THE VESSEL. REVASCULARIZATION WAS ATTEMPTED BUT UNSUCCESSFUL AND THE PHYSICIAN ELECTED TO TREAT MEDICALLY.

  Patient problems: Occlusion

  MAUDE report 6763550 ↗
• InjuryJun 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE SUCCESSFULLY IMPLANTED IN THE 1ST DIAGONAL. DURING THE PROCEDURE A DISSECTION OCCURRED POST IMPLANT OF THE SECOND RESOLUTE ONYX STENT. THE DISSECTION WAS TREATED WITH PCI AND THE PATIENT RECOVERED.

  Patient problems: Intimal Dissection

  MAUDE report 6666157 ↗