Resolute Onyx™ RONYX27538UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169556959), received between Dec 18, 2017 and Dec 11, 2024 — classified as 3 deaths, 17 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS, THE STENTS DID NOT DEPLOY AND REMAINED ON THE BALLOON. THE PROCEDURE TOOK PLACE IN THE RIGHT LOWER EXTREMITY. THE STENTS WERE REMOVED FROM THE BODY WITHOUT CAUSING INJURY TO THE PATIENT. THE DEVICES WERE INSPECTED, AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICES, AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901390 ↗
• MalfunctionDec 11, 2024Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS, THE STENTS DID NOT DEPLOY AND REMAINED ON THE BALLOON. THE PROCEDURE TOOK PLACE IN THE RIGHT LOWER EXTREMITY. THE STENTS WERE REMOVED FROM THE BODY WITHOUT CAUSING INJURY TO THE PATIENT. THE DEVICES WERE INSPECTED, AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICES, AND NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901376 ↗
• MalfunctionDec 5, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS (DES), AN ATTEMPT WAS MADE TO IMPLANT THE STENTS IN THE TIBIAL PERONEAL JUNCTION, BUT BOTH STENTS FELL OFF THE BALLOON. IT WAS NOTED THAT THIS WAS NOT A TIGHT STRICTURE AND NO FORCE WAS USED WHEN ATTEMPTING TO IMPLANT THE STENT. THE FIRST STENT WAS WAS INSERTED BUT IT WAS THOUGHT SOMETHING LOOKED OFF AND IT WAS FOUND THAT THE STENT FELL OF THE BALLOON. THE STENT WAS RETRIEVED AND IT WAS ATTEMPTED TO USE ANOTHER RESOLUTE ONYX DES WITH THE SAME LOT NUMBER. THE SAME THING HAPPENED WITH THE SECOND STENT. THIS STENT WAS ALSO RETRIEVED AND THE STENT DELIVERY SYSTEM WAS REMOVED. NEGATIVE PREP WAS NOT PERFORMED FOR EITHER DEVICE. THE USUAL STENT PREP WAS COMPLETED FOR BOTH STENTS. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THERE WAS NO INJURY TO THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852057 ↗
• MalfunctionDec 5, 2024Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS (DES), AN ATTEMPT WAS MADE TO IMPLANT THE STENT IN THE TIBIAL PERONEAL JUNCTION, BUT BOTH STENTS FELL OFF THE BALLOON. IT WAS NOTED THAT THIS WAS NOT A TIGHT STRICTURE AND NO FORCE WAS USED WHEN ATTEMPTING TO IMPLANT THE STENT. THE FIRST STENT WAS WAS INSERTED BUT IT WAS THOUGHT SOMETHING LOOKED OFF AND IT WAS FOUND THAT THE STENT FELL OF THE BALLOON. THE STENT WAS RETRIEVED AND IT WAS ATTEMPTED TO USE ANOTHER RESOLUTE ONYX DES WITH THE SAME LOT NUMBER. THE SAME THING HAPPENED WITH THE SECOND STENT. THIS STENT WAS ALSO RETRIEVED AND THE STENT DELIVERY SYSTEM WAS REMOVED. NEGATIVE PREP WAS NOT PERFORMED FOR EITHER DEVICE. THE USUAL STENT PREP WAS COMPLETED FOR BOTH STENTS. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THERE WAS NO INJURY TO THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852056 ↗
• InjuryAug 5, 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO AND AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 15173588 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE RESOLUTE ONYX STENTS WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED. BOTH STENTS DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOTED ADVANCING THE STENTS AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT AN ATTEMPT TO CROSS THE 2.75X38MM RESOLUTE ONYX STENT THROUGH PREVIOUSLY DEPLOYED STENTS FAILED AND DURING REMOVAL OF THE DEVCIE THE STENT BECAME DEFORMED AND DISLODGED IN THE LEFT MAIN. AN ATTEMPT WAS THEN MADE TO DELIVER AND DEPLOY THE 4.0 X 18MM RESOLUTE ONYX STENT AND THIS STENT ALSO DISLODGED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. BOTH STENTS WERE REMOVED USING A SNARE. ATHERECTOMY AND VESSEL PREP WAS COMPLETED AND A 3.0X 38MM RESOLUTE ONYX WAS IMPLANTED IN THE DISTAL LAD. NO FURTHER PATIENT INJURY WAS REPORTED.  TWO NC EUPHORA RX PTCA BALLOON CATHETERS WERE ALSO INTENDED TO BE USED DURING THIS PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE ISSUES NOTED DURING REMOVAL OF THE NC EUPHORA BALLOONS

  Patient problems: Insufficient Information

  MAUDE report 14652635 ↗
• InjuryMay 19, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH CHRONIC TOTAL OCCLUSION-CTO. IT WAS REPORTED THAT A FRAGMENT OF THE STENT-BALLOON CATHETER BECAME DISLODGED FROM THE TIP OF THE BALLOON. THE REPORTED DISLODGED FRAGMENT ULTIMATELY DISLODGED IN A TINY TERMINAL SIDE BRANCH OF THE DISTAL POSTEROLATERAL (PL) BRANCH. THE FRAGMENT WAS IDENTIFIED AS A RADIOPAQUE PIECE OF DEBRIS. IT WAS FELT THAT IT WAS NOT WORTH PURSUING TO RETRIEVE IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14446677 ↗
• MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. A GUIDEWAS ENGAGED IN THE ARTERY WITH A GUIDE EXTENSION CATHETER FOR EXTRA SUPPORT THROUGH THE VESSEL WITH A NON-MEDTRONIC GUIDE WIRE. IT WAS REPORTED THAT WHEN THE STENT WAS TRAVELLING ON THE GUIDE WIRE IT GOT STUCK ON THE RAMP OF THE GUIDE EXTENSION CATHETER AND DISLODGED FROM THE BALLOON. IT WAS STATED THAT ALL EQUIPMENT WAS TAKEN OUT OF THE PATIENT BODY WITH NO ISSUES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478444 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964762 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE LAD. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED OF CHEST PAIN. THE EVENT WAS TREATED WITH MEDICATION AND BLOOD TRANSFUSION. PATIENT RECOVERED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION (UNKNOWN VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 11647874 ↗
• MalfunctionFeb 10, 2021Inflation Problem; Inflation Problem

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED USING A 2.75X20MM EUPHORA BALLOON. 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 INFLATION DIFFICULTIES OCCURRED. IT WAS STATED THAT NOMINAL PRESSURE WAS ATTEMPTED BUT THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX OF THE SAME SIZE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307112 ↗
• MalfunctionJan 13, 2021Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 98% STENOSIS LOCATED 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 AND PRE-TREATED USING A NON-MEDTRONIC 1.5MM ROTABLATOR BURR, AND A 2.5X12MM SEMI COMPLIANT BALLOON. 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 STENT DEFORMATION / STENT FRACTURE OCCURRED IN VIVO POST DEPLOYMENT. IT WAS STATED THAT THE STENT WAS DELIVERED AND DEPLOYED WITH NO ISSUES NOTED, HOWEVER THERE WAS WASTE OBSERVED IN THE MID STENT SO POST DILATION OF THE STENT WAS CARRIED OUT. IT WAS STATED THAT THE STENT DEFORMATION/FRACTURE OCCURRED FOLLOWING POST DILATATION USING A 3.0 X 6 NC BALLOON WITH INFLATION PRESSURE OF 16 ATM, 22 ATM AND 24 ATM. THE FINAL RESULT WAS TIMI3 FLOW, BUT IT APPEARS THAT THE STENT IS BROKEN IN TWO, AS THERE IS A NOTICEABLE GAP IN THE MID STENT. THE PATIENT WAS REPORTED TO HAVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11162512 ↗
• DeathNov 11, 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 29 MONTHS POST INDEX PROCEDURE, PATIENT DIED FROM A BACTERIA IN VALVE. CEC ADJUDICATED THE EVENT AS CARDIAC DEATH. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTIPLATELET MEDICATION.

  Patient problems: Bacterial Infection; Death

  MAUDE report 10822022 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE COUGAR GUIDE WIRE TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED TO THE DEVICE WHEN REMOVING FROM THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU. THE TIP WAS FORMED BY THE PHYSICIAN. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING OR WITHDRAWING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. A LAUNCHER GUIDE CATHETER WAS ALSO USED. THE COUGAR GUIDE WIRE WAS ADVANCED IN THE RCA. A 2.5X15 MM EUPHORA BALLOON WAS USED TO PRE-DILATE THE LESION FOUR TIMES. A 2.75X38 MM RESOLUTE ONYX WAS IMPLANTED. THERE WAS POOR FLOW DISTAL TO THE STENT, WHERE AN EXPORT ASPIRATION CATHETER WAS INITIALLY USED TO ADMINISTER NITROGLYCERIN AND ADENOSINE. IVUS DETECTED A DISTAL EDGE STENT DISSECTION. A 2.5X22MM RESOLUTE ONYX WAS IMPLANTED, OVERLAPPING THE 2.75X38 MM STENT PROXIMALLY AND DISTAL FLOW IMPROVED. A 3.0X15 MM RESOLUTE ONYX STENT WAS ALSO INSERTED BUT WAS REMOVED UNDEPLOYED DUE TO THE COMPLI

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 10725876 ↗
• MalfunctionSep 24, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX DES WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON CAME OFF THE CATHETER WHILE INSIDE THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10580036 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX WERE IMPLANTED; ONE IN THE 1ST OBTUSE MARGINAL AND SECOND IN CX. APPROXIMATELY 15 MONTHS POST PROCEDURE, PATIENT SUFFERED CARDIAC CHEST PAIN REPORTED TO BE RELATED TO STENT THROMBOSIS IN THE STENT IMPLANTED IN 1ST OBTUSE MARGINAL. EVENT WAS TREATED WITH REVASCULARIZATION. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Thrombosis/Thrombus; Thrombus

  MAUDE report 10420473 ↗
• InjuryMay 27, 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVER TO/AT A LESION. IT WAS STATED THAT THE STENT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 10091025 ↗
• DeathMar 16, 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 WERE IMPLANTED : ONE IN THE IN THE R-PDA AND TWO IN THE RCA. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT DEATH OCCURRED. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED EVENT A CARDIAC DEATH.

  Patient problems: Death

  MAUDE report 9834607 ↗
• InjuryFeb 10, 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, TWO IN THE CIRCUMFLEX AND ONE IN THE RCA. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CEREBROVASCULAR ACCIDENT (STROKE). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Stroke/CVA

  MAUDE report 9686937 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM, PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). 100% STENOSIS WAS PRESENT. ALL DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL FOUR DEVICES WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL FOUR DEVICES BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ANY OF THE DEVICES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION AND AN MI OCCURRED IN RELATION TO THE TARGET VESSEL 7 HOURS POST STENT IMPLANTATION. THE CLOT WAS REMOVED BY ASPIRATION WITH A NON MEDTRONIC DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9590894 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND WAS REMOVED, ON REMOVAL STENT DEFORMATION WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A RESOLUTE ONYX 2.75 X 38MM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580217 ↗
• InjuryDec 12, 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 USED TO TREAT THE LAD. APPROXIMATELY 1 MONTH POST PROCEDURE PATIENT SUFFERED CHEST PAIN- NON ISCHEMIC AND WAS HOSPITALIZED AND TREATED WITH MEDICATION. CEC ADJUDICATED MI AS NON Q WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE INDEX DEVICE. THE PATIENT IS RECOVERING.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 9456713 ↗
• InjurySep 16, 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, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF THE TARGET VESSEL (LAD AND CX). 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 RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9069628 ↗
• MalfunctionMay 28, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT 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. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8646103 ↗
• 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 8635534 ↗