Resolute Onyx™ RONYX25026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169556836), received between Sep 4, 2017 and Oct 11, 2022 — classified as 2 deaths, 27 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID/DISTAL LEFT ANTERIOR DESCENDING (LAD) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS EXPIRED BY 9 DAYS DURING THE TIME OF IMPLANT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576131 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED HEPARIN INDUCED THROMBOCYTOPENIA AND THROMBOSIS POST STENT IMPLANTATION. PATIENT IS CURRENTLY IN HOSPITAL.

  Patient problems: Coagulation Disorder; Thrombosis/Thrombus

  MAUDE report 13839128 ↗
• MalfunctionOct 6, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION WITH 90% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. 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 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 ANOTHER RESOLUTE ONYX DEVICE OF THE SAME SIZE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583096 ↗
• MalfunctionAug 11, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION 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. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306148 ↗
• InjuryAug 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS AND MODERATELY CALCIFIED LESION IN THE PROXIMAL LAD WITH 99% STENOSIS. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. 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 STENT WAS UNABLE TO BE REMOVED DURING THE PCI PROCEDURE AND THE PATIENT WAS SENT FOR CABG. THE PATIENT IS ALIVE WITH NO INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12293535 ↗
• 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 12056262 ↗
• InjuryMar 26, 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED AGAINST A VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11573983 ↗
• DeathFeb 18, 2021Adverse 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 CIRCUMFLEX. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM A ISCHEMIC STROKE. IT AS STATED THAT THE PATIENT WAS ALSO HYPOTENSIVE EN-ROUTE TO THE HOSPITAL. PATIENT DIED 4 DAYS LATER THE EVENT. DEATH WAS CLASSIFIED AS NON-CARDIAC DEATH.

  Patient problems: Stroke/CVA

  MAUDE report 11341799 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LAD WITH 100% STENOSIS. THE PATIENT WAS ON COUMADIN DUE TO ATRIAL FIBRILLATION. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED FOR BOTH DEVICES. THE LESION WAS PREDILATED. 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. AFTER THE PCI, THE PATIENT DEVELOPED A GASTRIC BLEED AFTER THE STENT WAS IMPLANTED. A DECISION WAS MADE NOT TO START THE ANTIPLATELET MEDICATION FOR 2 DAYS AFTER THE PCI. SEVERAL DAYS LATER, THE PATIENT DEVELOPED CHEST PAIN AND A SUBSEQUENT HEART CATHETERISATION SHOWED STENT THROMBOSIS. THE THROMBOSIS WAS REMOVED AND THE STENTS WERE BALLOONED AND THE PATIENT WENT ON DAPT (ASPIRIN AND PLAVIX), THE PATIENT IS DOING FINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 11242963 ↗
• InjuryDec 1, 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 LAD. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATION. THE CEC ADJUDICATED THE EVENT A NON Q-WAVE MI OF UNKNOWN VESSEL. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10926875 ↗
• InjuryNov 26, 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 2ND OBTUSE MARGINAL AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. IT WAS REPORTED THAT ON THE SAME DAY POST INDEX PROCEDURE, PATIENT'S CARDIAC ENZYMES WERE ELEVATED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION IN THE 2ND OBTUSE MARGINAL.

  Patient problems: Myocardial Infarction

  MAUDE report 10911482 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX WERE IMPLANTED IN THE RCA. TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, PATIENT'S CARDIO BIOMARKER WERE ELEVATED. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI INVOLVING THE RCA. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELET MEDICATION BUT POSSIBLY RELATED TO INDEX DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10885382 ↗
• 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 THE INDEX DEVICE AND NOT TO THE ANTI-PLATELET MEDICATION AND THE PATIENT RECOVERED. CEC ADJUDICATED THAT APPROXIMATELY 20 DAYS POST STAGE PROCEDURE, PATIENT SUFFERED A TARGET VESSEL MYOCARDIAL INFARCTION INVOLVING THE LAD.

  Patient problems: Myocardial Infarction

  MAUDE report 10884428 ↗
• 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 10866537 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED COMPLAINING OF COUGH AND SHORTNESS OF BREATH FOR 3 WEEKS. THE PATIENT WAS NOTED TO BE COUGHING UP COPIOUS AMOUNTS OF BLOODY MUCOUS. SPUTUM CULTURES SHOWED KLEBSIELLA PNEUMONIA. THE PATIENT WAS ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC TREATMENT. THE PATIENT RECOVERED AND WAS DISCHARGED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Pneumonia

  MAUDE report 10768980 ↗
• DeathAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX RX STENTS WERE IMPLANTED BETWEEN THE DISTAL LAD WHICH HAD A CHRONIC TOTAL OCCLUSION AND THE PROX LAD WHICH HAD NO OCCLUSION. APPROXIMATELY 32 MONTHS LATER THE PATIENT SUFFERED CARDIOGENIC SHOCK AND CHEST PAIN. THE PATIENT WAS TREATED WITH MEDICATION. WITHIN 24 HOURS THE PATIENT PRESENTED TO ER WITH W/C/O CP & SOB; BRADYCARDIC FOLLOWED BY CARDIAC ARREST. THE PATIENT DIED DUE TO CARDIOGENIC SHOCK. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO INDEX DEVICE AND ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Cardiogenic Shock; Death; Myocardial Infarction

  MAUDE report 10447097 ↗
• InjuryFeb 5, 2020Adverse 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 AND THREE IN THE CIRCUMFLEX. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF A NON-TARGET VESSEL. EVENT WAS TREATED WITH CORONARY INTERVENTION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTI-PLATELET MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THE MI END POINT AS NON-Q-WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9670996 ↗
• InjuryFeb 5, 2020Adverse 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 AND THREE IN THE CIRCUMFLEX. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF A NON-TARGET VESSEL. EVENT WAS TREATED WITH CORONARY INTERVENTION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTI-PLATELET MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THE MI END POINT AS NON-Q-WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9670961 ↗
• 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 9552211 ↗
• MalfunctionDec 17, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE LAD. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE STENT WAS INSPECTED PRIOR TO USE. IT WAS STATED THAT THE STENT WENT INTO THE BODY THROUGH A GUIDELINER. AN ATTEMPT WAS MADE TO DELIVER THE STENT TO THE LESION BUT RESISTANCE WAS FELT AND THE STENT WAS REMOVED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT UPON INSPECTION ONCE REMOVED, IT WAS NOTICED THAT THE STENT STRUT HAD BEEN LIFTED AND WAS SET ASIDE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481053 ↗
• InjuryNov 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION EXHIBITED MODERATE TORTUOSITY AND SEVERE CALCIFICATION WITH 95% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT CARRIED OUT. STEP UP PRE-DILATION WAS CARRIED OUT. A GUIDE LINER WAS USED TO AID DELIVERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. THE DEVICE DID NOT PASS THROUGH ANY PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT FOLLOWING FAILED DELIVERY STENT DISLODGEMENT OCCURRED DURING PULLBACK WHILE ENTERING THE GUIDE LINER. THE STENT WAS REMOVED WITH A SNARE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 9271366 ↗
• InjurySep 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 RCA. TWO DAYS LATER A STAGED PROCEDURE WAS CARRIED OUT TO TREAT THE LAD WITH THE IMPLANTATION OF THREE RESOLUTE ONYX DRUG-ELUTING STENTS. POST STAGED PROCEDURE, A PLAQUE SHIFT OCCURRED IN 2ND DIAGONAL WITH TIMI FLOW 1-2 CAUSING ST ELEVATION IN LATERAL LEADS ON TELEMETRY. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI-PCI AND SLOW FLOW IN DIAGONAL.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9103957 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT DEVICE FAILED TO CROSS THE LESION DUE TO A STENT STRUT THAT BENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8938912 ↗
• MalfunctionMay 24, 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 LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 WAS UNABLE TO CROSS THE LESION AND UPON REMOVAL FROM THE PATIENT STENT DEFORMATION WAS OBSERVED WITH A STRUT OF THE STENT BECOMING LIFTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639555 ↗
• InjuryMay 20, 2019Device 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 MILDLY TORTUOUS AND CALCIFIED LESION EXHIBITING 20% STENOSIS LOCATED IN THE OSTIUM CIRCUMFLEX (CX) ARTERY-OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT WHILE ATTEMPTING TO DELIVER THE RESOLUTE ONYX STENT THROUGH THE CIRCUMFLEX ARTERY TO GET TO THE OBTUSE MARGINAL THAT THE RESOLUTE ONYX STENT BECAME CAUGHT ON A STRUT OF A STENT PREVIOUSLY IMPLANTED IN THE CIRCUMFLEX ARTERY. FORCE WAS USED TO PUSH THE RESOLUTE ONYX STENT THROUGH THE PREVIOUSLY IMPLANTED STENT BUT THE ONYX COULD NOT PASS. THE RESOLUTE ONYX STENT WAS PULLED BACK AND IT WAS NOTED THAT STENT DISLODGEMENT HAD OCCURRED. AN ATTEMPT WAS MADE TO ADVANCE THE DELIVERY BALLOON BACK INTO THE DISLODGED STENT BUT FAILED. DIFFERENT TYPES OF BALLOONS WERE ATTEMPTED TO REMOVE THE DISLODGED STENT BUT FAILED. THREE OR FOUR DIFFERENT SNARES WERE ATTEMPTED TO REMOVE THE DISLODGED STE

  Patient problems: Injury

  MAUDE report 8623358 ↗