Resolute Onyx™ RONYX30030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00643169557024), received between Jul 5, 2017 and Sep 5, 2024 — classified as 3 deaths, 26 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (20 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 49 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). TWO NC EUPHORIA BALLOONS AND ONE EUPHORA BALLOON WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE THE PATIENT UNDERWENT A CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION PROCEDURE DURING WHICH TWO ONYX FRONTIER DES WERE IMPLANTED IN THE MID LAD. THREE NC EUPHORA BALLOONS AND ONE LAUNCHER GUIDE CATHETER WERE ALSO USED DURING THIS REVASCULARIZATION PROCEDURE. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE AND 11 MONTHS POST THE REVASCULARIZATION PROCEDURE, THE PATIENT SUFFERED FROM A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) AND CHEST PAIN. THE PATIENT WENT TO THE EMERGENCY ROOM FOR SUBSTERNAL CHEST PAIN THAT RAISED TO THE LEFT SHOULDER, SOME SHORTNESS OF BREATH AND PALPITATIONS. THE PATIENT WAS NOTED TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR) AND WITH INCREASING TROPONINS. THE PATIENT WAS DIAGNOSED WITH A TYPE 2 SPONTANEOUS MYOCARDIAL INFARCTION (MI) WHICH WAS SECONDARY TO AN ISCHEMIC IMBALANCE. THE MI OCCURRED IN THE TERRITORY OF THE TARGET VESSEL. THE EVENT WAS TREATED WITH

  Patient problems: Arrhythmia; Atrial Fibrillation; Cardiac Enzyme Elevation; Chest Pain; Dyspnea; Insufficient Information; Ischemia; Myocardial Infarction

  MAUDE report 20144999 ↗
• InjuryApr 30, 2024Burst Container or Vessel; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Material Deformation; Burst Container or Vessel; Inflation Problem; Leak/Splash; Improper or Incorrect Procedure or Method; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID POSTERIOR TIBIAL ARTERY. THE DEVICE WAS NOT INSPECTED. 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 WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON BURST OR LEAK OCCURRED DURING STENT DEPLOYMENT. NOMINAL PRESSURE WAS APPLIED PRIOR TO THE BURST OR LEAK, BUT THE BALLOON WOULD NOT INFLATE. TWO INFLATIONS WERE APPLIED TO THE DEVICE PRIOR TO THE ISSUE. IT IS BELIEVED THAT THERE WAS A PIN SIZE HOLE IN THE BALLOON OF THE STENT. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 19210986 ↗
• MalfunctionDec 7, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS ADVANCED OVER THE WIRE TO THE LESION AND WOULD NOT CROSS. IT WAS DETAILED THAT WHEN THE STENT WAS REMOVED AND INSPECTED, THERE WAS A LIFTED STRUT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282271 ↗
• InjuryJul 27, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD). DURING THE PROCEDURE ONE EUPHORA BALLOON CATHETER WAS USED FOR PRE-DILATION AND TWO NC EUPHORA BALLOON CATHETERS WERE USED FOR POST DILATION. APPROXIMATELY SIX MONTHS POST PROCEDURE THE PATIENT PRESENTED AT THE HOSPITAL SUFFERING FROM SHORTNESS OF BREATH WHICH HAD BEEN INCREASING OVER THE PREVIOUS TWO WEEKS. TELEMETRY SHOWED ATRIAL FIBRILLATION (AFIB) AND CARDIOLOGY WERE CONSULTED. AFIB CONVERTED TO SINUS RHYTHM AND MULTIPLE TESTS WERE ORDERED, INCLUDING A STRESS TEST WHICH WAS ABNORMAL. INTERVENTIONAL CARDIOLOGY CHECKED THE PATENCY OF THE STENT. IT WAS DEEMED THE PREVIOUS STENT PLACED WAS POSSIBLY TOO SHORT OR WAS DUE TO PATIENT'S CHRONIC DISEASE. THE EVENT WAS TREATED WITH A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION. THIS WAS A TARGET VESSEL REVASCULARIZATION IN THE MID LAD AND WAS CLASSIFIED AS A TARGET LESION. THE PATIENT WAS TAKING DUAL ANTIPLATELET THERAPY WITHIN 24 HOURS PRIOR TO THE EVENT. THE PATIENT HAS RECOVERED FOLLOWING FOUR DAYS HOSPITALIZATION. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY REL

  Patient problems: Arrhythmia; Dyspnea; Insufficient Information; Stenosis

  MAUDE report 17409611 ↗
• InjuryJun 14, 2023Activation, 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

  A PATIENT HAD FOUR RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED ON (B)(6) 2022. THIS PROCEDURE WAS PERFORMED FOR CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE VESSEL HAD BEEN STENTED FROM THE OSTIUM TO THE DISTAL SEGMENT AT THE BIFURCATION OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) AND POSTEROLATERAL ARTERY (PLA). THE 2.5 X 38MM RESOLUTE ONYX STENT WAS INFLATED TO 14 ATM, THE 3.0 X 38MM RESOLUTE ONYX STENT WAS INFLATED TO 12 ATM, THE 3.0 X 30MM RESOLUTE ONYX STENT WAS INFLATED TO 15 ATM, AND THE 2.25 X 26MM RESOLUTE ONYX STENT WAS INFLATED TO 10 ATM FOLLOWED BY THE BALLOON AT 24 ATM. A 3.0 X 30MM NON-MEDTRONIC (MDT) BALLOON WAS USED FOR POST-DILATION UP TO 22 ATM AS WELL AS A 2 X 15MM BALLOON UP TO 10 ATM. ALL STENT BALLOONS SUCCESSFULLY DEFLATED POST STENT DILATION. THERE WERE NO DIFFICULTIES NOTED DURING THE REMOVAL OF THE GUIDEWIRE. THE BALLOON OR THE DELIVERY SYSTEM DID NOT SNAG ON THE DEPLOYED STENTS. THERE WERE NO DIFFICULTIES DURING STENT DEPLOYMENT AND THERE WERE NO COMPLICATIONS. APPROXIMATELY 11 MONTHS LATER IT WAS REPORTED THAT THE PATIENT EXPERIENCED, AND SHOWED SIGNS OF WHAT WAS THOUGHT TO BE ANOTHER HEART ATTACK AND ATTENDED THE ED

  Patient problems: Angina; Anxiety; Chest Pain; Dizziness; Dyspnea; Myocardial Infarction; Nausea

  MAUDE report 17123433 ↗
• InjuryMay 24, 2023Fracture; Material Deformation; Fracture; Material Deformation

  ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) WAS IMPLANTED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE 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 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT DURING A DIAGNOSTIC ANGIOGRAM IT APPEARED THE STENT HAD FRACTURED SINCE IMPLANTATION THIRTEEN MONTHS AGO. IT WAS NOTED THAT THE STENT HAD NOT DETACHED HOWEVER, THERE APPEARED TO BE A GAP WITHIN THE 30MM STENT. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 16992928 ↗
• InjuryAug 2, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS LEFT IN THE BODY AND ANOTHER STENT WAS USED TO CRUSHED THE DISLODGED STENT AGAINST THE VESSEL WALL. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15146860 ↗
• MalfunctionMay 20, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 85% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING TWO OTHER RESOLUTE ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14447854 ↗
• MalfunctionFeb 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT A CATHETER DETACHMENT OCCURRED WHEN ADVANCING THE DEVICE THROUGH THE GUIDE CATHETER. THE DETACHED PORTION WAS REMOVED WITH NO ISSUES NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534841 ↗
• InjuryJan 7, 2022Burst Container or Vessel; Inflation Problem; Leak/Splash; Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Inflation Problem; Leak/Splash; Migration or Expulsion of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT. IT WAS ALSO REPORTED THAT HE BALLOON BURST AT 6 ATM DURING STENT DEPLOYMENT AT THE LESION SITE. FROM THE FILM, IT WAS SUGGESTED THE BALLOON DID NOT APPEAR TO INFLATE MORE THAN 2 ATMS. IT WAS ALSO SUGGESTED THAT EITHER THE DEVICE WAS DEFECTIVE DUE TO THE LACK OF HIGH PRESSURE OR IT WAS A SHARP PLAQUE. A FILTER WAS IN USE TO REMOVE THE STENT. WHEN ATTEMPTING TO REMOVE THE FILTER AND THE STENT BACK TO THE FEMORAL RIGHT SIDE, IT GOT STICK AT THE SHEATH AND COULD NOT BE REMOVED. A 7F SHEATH WAS THEN USED IN THE LEFT SIDE TO GO OVER THE HORN AND SNARE THE FILTER, PULLING EVERYTHING OUT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13191249 ↗
• MalfunctionDec 15, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT DEVICE TO TREAT A CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT STENT WAS DEFECTIVE AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010050 ↗
• InjuryOct 19, 2021Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 90% STENOSIS 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT DURING DELIVERY TO THE LESION STENT DISLODGEMENT OCCURRED WHEN PULLING PROXIMALLY DUE TO INTERACTION WITH AN EXISTING STENT. DESPITE NUMEROUS ATTEMPTS, SNARING THE ENTIRE STENT WAS UNSUCCESSFUL AND ONLY A PORTION OF THE STENT WAS ABLE TO BE RETRIEVED AND WAS BADLY DEFORMED. THE REMAINING PORTION OF THE STENT WAS CRUSHED AGAINST THE ARTERIAL WALL WITH A BALLOON. TWO OTHER STENTS WERE THEN IMPLANTED AND SUFFICIENT FLOW WAS ACHIEVED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12656100 ↗
• MalfunctionOct 1, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND HAD RAISED STRUTS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561171 ↗
• InjuryJun 1, 2021Adverse 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 1ST LPL. ONE DAY AFTER THE PROCEDURE PATIENT SUFFERED FROM ELEVATED TROPONIN POST PROCEDURE. CEC ADJUDICATED A TARGET VESSEL MI OCCURRED (1ST LPL) AND COMMENTED "CARDIAC ENZYMES FALLING PRIOR TO PROCEDURE, THEN SIGNIFICANT RISE POST PROCEDURE". THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11912464 ↗
• MalfunctionMar 16, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492036 ↗
• DeathJan 11, 2021Adverse 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 AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM PULSELESS ELECTRICAL ACTIVITY ARREST AND A POSSIBILITY OF ABDOMINAL BLEEDING WAS ALSO REPORTED. PATIENT WAS NOT ON DAPT 24 HOURS PRIOR TO EVENT. BLOOD TRANSFUSION WAS GIVEN AND RESUSCITATION EFFORTS WERE PERFORMED BUT THE PATIENT DIED. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. 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 ANTIPLATELETS MEDICATION.

  Patient problems: Cardiac Arrest

  MAUDE report 11146353 ↗
• DeathDec 17, 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 GRAFT 1ST OBTUSE MARGINAL. APPROXIMATELY 14.5 MONTHS POST PROCEDURE THE PATIENT DIED. IT IS REPORTED THAT THE PATIENTS COPD WAS WORSENING AND THEY WERE PLACED IN HOSPICE CARE. CAUSE OF DEATH PER DEATH CERTIFICATE IN ORDER IS ISCHEMIC CARDIOMYOPATHY, CORONARY ARTERY DISEASE, HYPERTENSION AND DIABETES. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Cardiomyopathy

  MAUDE report 11027907 ↗
• InjuryDec 1, 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 LAD. FOLLOWING DAY, DURING A STAGED PROCEDURE, A RESOLUTE ONYX WAS ALSO IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED CHEST PAIN - ACUTE CORONARY SYNDROME AND REVASCULARIZATION OF THE TARGET VESSELS. TWO STENTS WERE IMPLANTED; ONE IN THE LAD AND THE OTHER IN THE CX. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF TARGET VESSEL 3RD UDMI SPONTANEOUS AND REVASCULARIZATION IS NOT AN EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 10927258 ↗
• MalfunctionOct 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX DES WAS USED TO TREAT A MODERATE CALCIFIED, MILD TORTUOSITY LESION IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY, C IRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUE REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY UNDER DEPLOYED STENT USING A 5FR GUIDE, RESISTANCE WAS ENCOUNTERED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THEY WERE ABLE TO BALLOON THE STENT. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 10761938 ↗
• DeathOct 27, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  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 INFLATION DIFFICULTIES WERE ENCOUNTERED DURING STENT DEPLOYMENT. THE STENT WOULD NOT DEPLOY DURING AN EMERGENCY CASE. THE INDEFLATOR WAS SWITCHED OUT AND ATTEMPTS WERE MADE TO FLUSH THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10742311 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD . DURING A REVASCULARIZATION PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. DURING A SECOND REVASCULARIZATION PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RPL. DURING A THIRD REVASCULARIZATION PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. DURING A FOURTH REVASCULARIZATION PROCEDURE ONE RESOLUTE INTEGRITY BMS AS IMPLANTED IN THE RCA. DURING A FIFTH REVASCULARIZATION PROCEDURE TO TREAT SEVERELY CALCIFIED RCA AND INTENT RESTENOSIS OF THE MID RCA PLAQUE PROLAPSE WAS NOTED AND THE PATIENT WAS TREATED WITH TWO MEDTRONIC STENTS IN THE RCA. THE PLAQUE PROLAPSE WAS NOT PRESENT PRIOR TO THE STENT IN THE MID RCA, PROLAPSE OCCURRED AFTER THE POST DILATION OF MID RCA. PLAQUE PROLAPSE CAUSED OCCLUSION IN THE OSTIAL RCA THEREFORE OSTIAL RCA WAS STENTED. THE PATIENT WAS DISCHARGED HOME. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND UNLIKELY RELATED TO THE INDEX DEVICE. THE PLAQUE PROLAPSE WAS NOT PRESENT PRIOR TO T

  Patient problems: Obstruction/Occlusion; Occlusion

  MAUDE report 10710437 ↗
• InjuryOct 14, 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. ONE RESOLUTE ONYX DES WAS ALSO IMPLANTED IN THE 1ST OBTUSE MARGINAL DURING A STAGED PROCEDURE. APPROXIMATELY 14 MONTHS LATER THE PATIENT SUFFERED RECTAL BLEEDING. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND NOT RELATED TO THE DEVICE.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10676569 ↗
• MalfunctionSep 2, 2020Material Deformation; Material Deformation

  ONE RESOLUTE ONYX DES WAS ATTEMPTED TO BE USED DURING A HEART CATH PROCEDURE. IT WAS REPORTED THAT THE STENT BUCKLED ON ITSELF WHEN ATTEMPTING TO PLACE IN THE TARGET VESSEL. THE STENT WAS REMOVED WITHOUT COMPLICATIONS. ANOTHER 3.0X30 MM RESOLUTE ONYX DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482124 ↗
• MalfunctionAug 19, 2020Material Twisted/Bent

  ELDERLY MALE WITH HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION AND CHEST PAIN. WHILE HAVING A HEART CATH PROCEDURE, THE ONYX STENT BUCKLED ON ITSELF WHEN ATTEMPTING TO PLACE IT IN THE TARGET VESSEL. REMOVED WITHOUT KNOWN COMPLICATIONS. PROCEDURE WAS HEART CATH, LEFT STENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). IT WAS SUCCESSFULLY REMOVED WITHOUT KNOWN COMPLICATION. ANOTHER 3.0 X 30 ONYX STENT WAS DEPLOYED IN ITS PLACE. DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: No Code Available

  MAUDE report 10424870 ↗
• MalfunctionMay 1, 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 NON TORTUOUS, NON CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT CAME OFF THE DELIVERY SYSTEM UPON INSERTION AND MIGRATED. THE DISLODGED STENT REMAINS IN THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10016734 ↗