Resolute Onyx™ RONYX22518UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169556720), received between Sep 28, 2017 and Apr 5, 2022 — classified as 5 deaths, 23 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryApr 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT CAME OFF THE BALLOON AFTER IT WOULDN¿T CROSS THE LESION AND WHEN THE STENT WAS PULLED BACK INTO A NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND THE STENT WAS CRUSHED AGAINST THE ARTERY WALL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14011026 ↗
• MalfunctionMar 8, 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 CALCIFIED, SEVERELY TORTUOUS LESION WITH 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS NOT ON THE DELIVERY BALLOON WHEN REMOVED FROM THE BODY. THE DISLODGED STENT WAS NOT REMOVED AS IT COULD NOT BE FOUND AND THE LOCATION IS UNKNOWN. X-RAY WAS USED TO LOOK THROUGHOUT THE BODY FOR THE DISLODGED STENT AND THE GUIDE CATHETER AND SHEATH WERE FLUSHED BUT THE STENT COULD NOT BE FOUND. NO INTERVENTION WAS CARRIED OUT. THE PATIENT IS ALIVE WITH NO INJURY. IT WAS STATED THAT THERE WAS A CHANCE THAT THE STENT DISLODGEMENT TOOK PLACE OUTSIDE THE PATIENT'S BODY, BUT THIS COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694579 ↗
• MalfunctionApr 1, 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. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. IT WAS STATED THAT THE STENT WAS ATTEMPTED TO CROSS THE LESION A COUPLE OF TIMES, WHEN REMOVING THE UNDEPLOYED STENT FROM THE WIRE IT WAS NOTED THAT THE STENT WAS COMING OFF THE BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601013 ↗
• InjuryDec 11, 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 DELIVERY TO/AT A LESION. IT WAS STATED THAT THE STENT WAS NOT REMOVED AND REMAINED IN THE PATIENT. IT WAS STATED THAT THE PATIENT WAS SENT TO SURGERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10990467 ↗
• InjuryNov 30, 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. CEC ADJUDICATED THAT PATIENT SUFFERED A TARGET VESSEL MI INVOLVING THE CIRCUMFLEX APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 10918329 ↗
• MalfunctionNov 25, 2020Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE DEVICE WAS INSPECTED PRIOR TO USE 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. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND UPON REMOVAL THE STENT WAS NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905066 ↗
• DeathSep 25, 2020Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  A RESOLUTE ONYX DES WAS USED DURING A PROCEDURE TO TREAT A ACUTE MI/NSTEMI MULTI VESSEL DISEASE. THE LESION WAS 100% OCCLUSION AND WAS UNABLE TO BE CROSSED. THEY PROCEEDED WITH INTERVENTION OF THE L CIRCUMFLEX ARTERY. THIS WAS DIFFICULT TO CROSS DUE TO THE ANGULATION. THE BALLOON DID MANAGE TO CROSS THIS LESION. THE ONYX STENT WAS ADVANCED BUT WOULD NOT CROSS THE LESION. IT WAS REPORTED THAT WHEN THEY PULLED BACK THE STENT DUE TO THE OCCLUSION OF THE CIRCUMFLEX ARTERY THE STENT DISLODGED OFF THE BALLOON. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT BUT THIS APPEARED TO INTERRUPT THE FLOW OF THE LAD ARTERY. THE PATIENT WAS UNSTABLE. THEY PROCEED WITH THE PCI TO THE LAD. THE STENT WAS SUCCESSFULLY DELIVERED IN THE LAD. THE L CIRCUMFLEX ARTERY REMAINED OCCLUDED. MULTIPLE ATTEMPTS WERE MADE BUT NOT SUCCESSFUL. PATIENT HAD RE-OCCURRING VFIB, ACLS/CPR MEASURES WERE UNSUCCESSFUL. THE PATIENT DIED.

  Patient problems: Death; Occlusion

  MAUDE report 10585071 ↗
• MalfunctionAug 27, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE RESOLUTE ONYX STENT (LOT 0009833921) DISLODGED DURING DELIVERY IN THE LAD WHILE ATTEMPTING TO DELIVER THE STENT TO THE DIAGONAL BRANCH. IT WAS STATED THAT THE STENT FLARED AND WAS JAILED BY ANOTHER STENT THAT WAS DEPLOYED ACROSS THE DIAGONAL BRANCH. ANOTHER STENT WAS USED TO CRUSH THE DISLODGED STENT INTO THE WALL OF THE MID LAD. IT WAS ALSO REPORTED THAT THE SECOND RESOLUTE ONYX STENT (LOT 0009983738) DEFORMED IN VIVO DURING POSITIONING. IT WAS STATED THAT THE PHYSICIAN COMPLETED THE PROCEDURE USING ANOTHER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 10458481 ↗
• 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 10447121 ↗
• InjuryJun 24, 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 RAMUS. APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM GI BLEED. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. EVENT WAS TREATED WITH MEDICATION AND PERCUTANEOUS INTERVENTION. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 10188014 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, STROKE AND HISTORY OF PAD. INDEX PROCEDURE WAS PROMPTED BY UNSTABLE ANGINA AND POSITIVE STRESS TEST. DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD. FOLLOWING DAY, PATIENT HAD ELEVATED TROPONIN LEVEL. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE ANTIPLATELET. CEC ADJUDICATED THE EVENT AS MI (TARGET VESSEL), INVOLVING THE LAD. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 9865709 ↗
• MalfunctionFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX (4.00 X 26MM) AND ONE RESOLUTE ONYX RX (2.25 X 18MM) DRUG ELUTING STENTS TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESIONS WERE NOT PRE-DILATED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX RX (4.00 X 26MM) DEVICE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX RX (2.25 X 18MM) DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF EITHER DEVICE. IT WAS REPORTED THAT BOTH STENTS DISLODGED DURING REMOVAL FOLLOWING FAILED DELIVERIES. IT WAS REPORTED THAT AFTER THE RESOLUTE ONYX RX (4.00 X 26MM) FAILED TO CROSS THE LESION IT WAS PULLED BACK INTO THE Y ADAPTER. THE STENT THEN GOT "HUNG UP" ON THE Y ADAPTER AND CAME OFF THE DELIVERY CATHETER. IT WAS REPORTED THAT THE RESOLUTE ONYX RX (2.25 X 18MM) DISLODGED IN THE Y ADAPTER. BOTH DEVICES WERE RETRIEVED SUCCESSFULLY. THE DISLODGED STENTS WERE REMOVED BY THE PHYSICIANS HAND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9710352 ↗
• InjuryFeb 13, 2020Activation, 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 RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A MODERATELY TORTUOUS LESION IN THE DISTAL RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT DISTAL R-PDA STENT THROMBOSIS OCCURRED POST DEPLOYMENT OF THE STENT.

  Patient problems: Chest Pain; Thrombus

  MAUDE report 9705975 ↗
• DeathFeb 7, 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 RCA AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION AND DIED ON THE SAME DAY. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE AND ANTIPLATELETS MEDICATION.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 9680712 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH AN (B)(6). A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 99% STENOSIS IN THE OBTUSE MARGINAL (OM) 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT, THE PATIENT RETURNED WITH STENT THROMBOSIS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Occlusion; Thrombus

  MAUDE report 9675716 ↗
• 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 9670937 ↗
• MalfunctionJan 30, 2020Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A VERY CALCIFIED LESION. IT WAS REPORTED THAT THE STENT DISLODGED AFTER REMOVAL FROM THE PATIENT AND THAT THE CATHETER DELIVERY SYSTEM WAS DEFORMED. THE PHYSICIAN USED A GUIDE LINER AND THOUGHT THE STENT WAS DEPLOYED BUT THINKS THE CALCIFICATION AND THE GUIDELINER MADE THE STENT DISLODGE OFF THE CATHETER. ANOTHER ONYX STENT WAS USED TO TREAT THE LESION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646394 ↗
• 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 RCA. APPROXIMATELY 3 WEEKS POST PROCEDURE PATIENT SUFFERED DEMAND ISCHEMIA. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY TO THE DEVICE BUT NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ADJUDICATED THE EVENT A NON Q-WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9495246 ↗
• InjurySep 4, 2019Adverse 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 RCA. SAME DAY PATIENT SUFFERED LOWER GI BLEED WITH COLONOSCOPY CARRIED OUT. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI-PLATELET. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET.

  Patient problems: Blood Loss

  MAUDE report 8959906 ↗
• InjuryJul 31, 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 CX .IT WAS REPORTED THE PATIENT SUFFERED MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 8844976 ↗
• InjuryJun 24, 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 RCA. ON THE SAME DAY, THE PATIENT SUFFERED STEMI. THE PATIENT WAS TREATED WITH SURGICAL PROCEDURE. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 8726103 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED INTO THE LAD, ONE INTO THE CX AND TWO INTO THE 1ST DIAGONAL. ONE DAY POST INDEX PROCEDURE, ELEVATED CARDIAC ENZYMES WAS REPORTED. NO ACTION WAS TAKEN. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. THE OUTCOME OF THE EVENT IS UNKNOWN. CEC ADJUDICATED THE EVENT AS NON Q WAVE MI (TV) 3RD UDMI PERI-PCI AND COMMENTED THERE WAS A SIDE BRANCH OCCLUSION.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8673981 ↗
• InjuryMay 29, 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 SEVERELY TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 85% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT 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 IS REPORTED THAT THE STENT DISLODGE DURING DELIVERY TO THE LESION. A SNARE HAD TO BE USED TO REMOVE THE STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 8649202 ↗
• MalfunctionMar 29, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE MID TO DISTAL LAD. 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A RESOLUTE ONYX 2.25 X 15 MM DES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463800 ↗
• MalfunctionMar 25, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND BECAME DEFORMED WITH A STRUT OF THE STENT BECOMING LIFTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448523 ↗