Resolute Onyx™ RONYX22515UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00643169556713), received between Jul 24, 2017 and Mar 3, 2023 — classified as 2 deaths, 43 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (16 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2023Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENTS AND TWO EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON ANY OF THE DEVICES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 2.75 X 22MM RESOLUTE ONYX STENT BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE TWO EUPHORA RX DEVICES AND THE 2.5 X 15 MM RESOLUTE ONYX STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THESE DEVICES. IT WAS REPORTED THAT THE FIRST STENT, THE 2.75 X 22MM RESOLUTE ONYX STENT FAILED TO CROSS THE LESION. IT WAS BELIEVED THAT THE STENT FAILED TO CROSS DUE TO HEAVY CALCIUM AND A POSSIBLE SURGICAL SUTURE AT THE SITE OF IMPLANT. THE STENT WAS REMOVED UNDEPLOYED. AN ATTEMPT WAS MADE TO PREDILATE THE SVG LESION WITH TWO 2.5 X 12 MM EUPHORA RX BALLOONS HOWEVER DURING BALLOON INFLATION THE BALLOONS BURST. IT WAS DETAILED THAT THE FIRST EUPHORA RX BALLOON BALLOON BURST

  Patient problems: Insufficient Information

  MAUDE report 16477705 ↗
• InjurySep 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS POST-DILATED WITH A SEPARATE BALLOON AT AN UNINTENDED SITE WHICH WAS NOT AT THE SITE OF THE TARGET LESION. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15453407 ↗
• 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. 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO AND AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. A SMALLER 2.0MM COMPLAINT BALLOON WAS DELIVERED INTO THE DISLODGED STENT INFLATED TO THE DESIRED DIAMETER. THE DISLODGED STENT WAS SUCCESSFULLY DEPLOYED AND WAS WELL APPOSED TO THE ARTERIAL WALL UPON COMPLETION. THE LESION WAS DESCRIBED AS AN ENORMOUS TIGHT ROCK OF CALCIUM WHICH THE PHYSICIAN ANTICIPATED WOULD COMPLICATE THIS PCI. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15173611 ↗
• MalfunctionFeb 4, 2022Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A CALCIFIED LESION IN THE MID CIRCUMFLEX (CX). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN REMOVED WAS NOTED TO BE FRAYED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13449456 ↗
• MalfunctionDec 14, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND A 6F LAUNCHER GUIDE CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LAUNCHER WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE RESOLUTE ONYX WAS NOT INSPECTED BEFORE USE. 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 NON MEDTRONIC WIRE BECAME STUCK IN THE LAD AND THE DISTAL WIRE TIP BROKE INSIDE THE PATIENT DUE TO THE FORCE NEEDED TO REMOVE THE WIRE. ON THE REMOVAL PROCEDURE, THE RESOLUTE ONYX STENT BECAME DEFORMED IN VIVO WHEN USING A SNARE AND OTHER TECHNIQUES TO RETRIEVE THE NON-MEDTRONIC WIRE. THE SNARE ALSO BROKE INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED FOR AN OPEN HEART BYPASS SURGERY AND REQUIRED A GRAFT IN THE LAD. THE PATIENT IS REPORTED TO BE ALIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001972 ↗
• InjuryAug 16, 2021Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION, WITH 90% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. 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 THE RESOLUTE ONYX DRUG ELUTING STENT WAS UNABLE TO CROSS THE LESION, IT WAS PULLED OUT OF THE PATIENT AND EVALUATED. THE STENT WAS CONSIDERED FULLY INTACT, THEN THE LESION SITE WAS AGAIN PRE-DILATED AND THE SAME RESOLUTE ONYX DRUG ELUTING STENT WAS THEN ATTEMPTED. DURING PLACEMENT, THE LAUNCHER GUIDE CATHETER AND THE WIRE BUCKLED IN THE VESSEL, THE UNDEPLOYED STENT MOVED FORWARD AND BECAME DISLODGED FROM THE BALLOON/CATHETER. FROM THE ARTERY, THE STENT MIGRATED AND WAS WEDGED INTO A BRANCH OF THE LEFT RENAL. FEMORAL ACCESS WAS OBTAINED AND THE STENT WAS SNARED FROM THE RENAL ARTERY/ KIDNEY SUCCESSFULLY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12324477 ↗
• InjuryMay 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER WERE ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 USED DURING DELIVERY OF THE RESOLUTE ONYX BUT NOT THE TELESCOPE. THE TELESCOPE WAS NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE SUCCESSFULLY DELIVERED BEYOND THE CALCIFIED PLAQUE AND ATTEMPTS TO REMOVE THE DEVICE RESULTED IN STENT DISLODGEMENT. BALLOON ANGIOPLASTY WAS THEN PERFORMED AND THE DISLODGED STENT CRUSHED AGAINST THE VESSEL WALL. IT WAS STATED THAT TACTILE FEEDBACK INDICATED THE STENT MAY HAVE ENCOUNTERED THE TELESCOPE DURING DELIVERY, FACILITATING THE STENT DISLODGEMENT. IT WAS INDICATED BY THE PHYSICIAN THAT ATTEMPTS TO WITHDRAW THE UNDEPLOYED STENT INTO THE TELESCOPE DIRECTLY NEAR THE LESION SITE MAY ALSO HAVE CONTRIBUTED TO THE EVENT. IT WAS ALSO REPORTED THAT RE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11906894 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD AND RCA. APPROXIMATELY 17 MONTHS LATER THE PATIENT SUFFERED CHEST PAIN, ELEVATED TROPONIN AND MYOCARDIAL INFARCTION THAT WAS DIAGNOSED AS EXACERBATION OF HEART FAILURE. EVENT TREATED WITH HOSPITALIZATION AND MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THAT THE PATIENT SUFFERED MI OF UNKNOWN VESSEL.

  Patient problems: Myocardial Infarction

  MAUDE report 11692423 ↗
• InjuryApr 13, 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 1ST OBTUSE MARGINAL. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT SUFFERED OF CARDIAC ARREST AFTER BELOW-KNEE AMPUTATION. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED A MYOCARDIAL INFARCTION OCCURRED (UNKNOWN VESSEL) DUE TO TROPONIN INCREASE AFTER PROLONGED RESUSCITATION.

  Patient problems: Myocardial Infarction

  MAUDE report 11655018 ↗
• InjuryDec 2, 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, MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10934318 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, FOUR RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX. TWO EUPHORA PTCA BALLOON WERE ALSO USED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED CARDIAC ENZYMES. INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED. THE CEC ADJUDICATED THAT A MI OCCURRED IN THE TARGET VESSEL, THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 10894264 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. ONE RESOLUTE ONYX DES WAS IMPLANTED DURING ANOTHER REVASC TO TREAT THE 1ST OBTUSE MARGINAL. APPROXIMATELY 34 MONTHS LATER, THE PATIENT SUFFERED MI. EVENT WAS TREATED WITH HOSPITALIZATION, MEDICATION AND PCI. PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTI-PLATELET MEDICATION. SAFETY COMMENTED "REVASC NTV. STENTING WAS CARRIED OUT IN THE 1ST OBTUSE MARGINAL AND RCA DURING A REVASCULARIZATION PROCEDURE. CEC ADJUDICATED MI AS NON-Q-WAVE MI OF THE RCA AND THE CX (NON-TARGET VESSEL). CEC ADJUDICATED REVASCULARIZATION OF THE RCA AND CX AS NON-TVR-PCI.

  Patient problems: Myocardial Infarction

  MAUDE report 10866625 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED IN THE LAD. APPROX 3 MONTHS POST THIS PROCEDURE THE PATIENT SUFFERED THROMBUS IN THE RPL. THE THROMBUS WAS REPORTED TO BE STENT THROMBOSIS RELATING TO 2 RESOLUTE ONYX STENTS IMPLANTED DURING A DIFFERENT PROCEDURE TO THAT OF THE LAD 3MONTHS PREVIOUS. THE PATIENT WAS TREATED WITH CORONARY INTERVENTION AND MEDICATION. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE IMPLANTED IN THE LAD OR ANTI-PLATELET MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10654531 ↗
• InjuryAug 27, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; 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: Injury; Insufficient Information; Obstruction/Occlusion; Occlusion

  MAUDE report 10458470 ↗
• MalfunctionMar 4, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON COMPONENT DETACHED, CRACKED OR FRACTURED DURING REMOVAL OF THE DEVICE. IT WAS STATED THE PHYSICIAN REMOVED THE DEVICE SO THEY COULD RETURN AGAIN AND DEPLOY THE STENT, HOWEVER THE STENT WAS DETACHED OUTSIDE THE PATIENT BEFORE THEY COULD REDEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9784795 ↗
• InjuryMar 4, 2020Adverse 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 RCA. APPROXIMATELY 10 MONTHS LATER THE PATIENT SUFFERED PAROXYSMAL ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. EVENT WAS TREATED WITH HOSPITALIZATION AND MEDICATION. THE PATIENT RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. CEC ADJUDICATED MI OF AN UNKNOWN VESSEL. SAFETY COMMENTED MI, VESSEL UNKNOWN.

  Patient problems: Myocardial Infarction

  MAUDE report 9784695 ↗
• 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. CEC ADJUDICATED THE REVASCULARIZATION END POINT AS NO EVENT AND COMMENTED THAT NO REVASCULARIZATION WAS PERFORMED.

  Patient problems: Myocardial Infarction

  MAUDE report 9670923 ↗
• InjuryJan 22, 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 CIRCUMFLEX. CEC ADJUDICATED THAT THE PATIENT HAD NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI PERI-PCI DUE TO LABORATORY RESULTS .

  Patient problems: Myocardial Infarction

  MAUDE report 9615546 ↗
• InjuryJan 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY/MAMMARY GRAFT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU WITHOUT ISSUE. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUES. THE LESION WAS PRE-DILATED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION SITE, WITH THE STENT FALLING OFF THE STENT BALLOON UNDEPLOYED. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9611224 ↗
• InjuryJan 21, 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 RCA. APPROXIMATELY 11 MONTHS POST PROCEDURE, PATIENT SUFFERED SUBDURAL HEMATOMA WHICH IS ASSOCIATED WITH BLEEDING EVENT. CT SCAN SHOWED NEW RIGHT SUBDURAL FLUID COLLECTION AND HEMATOMA. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Hematoma; Stroke/CVA

  MAUDE report 9609687 ↗
• InjuryJan 17, 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. DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS , PATIENT SUFFERED NSTEMI IN THE RCA. THE EVENT WAS TREATED WITH 2 RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA AND THE PATIENT RECOVERED. THE SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9602088 ↗
• InjuryJan 17, 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. DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS, PATIENT SUFFERED NSTEMI IN THE RCA. EVENT WAS TREATED WITH 2 RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA. SHORTLY AFTER PROCEDURE PATIENT BECAME SHORT OF BREATH, EKG SHOWED STEMI AND WAS TREATED WITH ANOTHER PCI. PATIENT RECOVERED. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9601908 ↗
• InjuryJan 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. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, DURING FIRST REVASCULARIZATION TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. IT WAS REPORTED THAT ON THE SAME DAY OF THE REVASCULARIZATION, POST STENTING, PATIENT SUFFERED FROM OCCLUSION CAUSED BY A PLAQUE SHIFT INTO MAIN POSTEROLATERAL BRANCH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 9574122 ↗
• InjuryJan 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. APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE, DURING A SECOND REVASCULARIZATION PATIENT SUFFERED FROM OCCLUSION CAUSED BY A PLAQUE SHIFT INTO PREVIOUSLY STENTED SUB BRANCH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 9574084 ↗
• InjuryJan 8, 2020Adverse 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 1ST OBTUSE MARGINAL. APPROXIMATELY 5 MONTHS POST PROCEDURE, PATIENT SUFFERED WORSENING OF END STAGE RENAL DISEASE WHICH WAS TREATED WITH PERITONEAL DIALYSIS. PATIENT RECOVERED. CEC ADJUDICATED NON-Q-WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTAENOUS. INVESTIGATOR AND SAFETY ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9563432 ↗