Resolute Onyx™ RONYX35022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169557093), received between Oct 24, 2017 and Jan 26, 2023 — classified as 1 death, 15 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (10 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2023Use of Device Problem; Use of Device Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT THE IMPLANTED STENT HAD EXPIRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245314 ↗
• MalfunctionOct 12, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS TO TREAT A NON-TORTUOUS, NON-CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE DEVICES FAILED TO CROSS THE LESION AND THE STENTS WERE DAMAGED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585722 ↗
• InjuryOct 11, 2022Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Inflation Problem; Leak/Splash; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A NON-CALCIFIED LESION WITH 99% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED 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 THE DELIVERY. IT WAS REPORTED THAT A BALLOON BURST/LEAK OCCURRED DURING STENT DEPLOYMENT. THE PATIENT HAD UNDERGO OPEN HEART SURGERY TO REMOVE THE UNEXPANDED STENT IN THE MID CIRCUMFLEX (CX) ARTERY. THE PATIENT IS REPORTED TO BE ALIVE WITH INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15578708 ↗
• MalfunctionAug 5, 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. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON EITHER DEVICE. 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 BOTH STENTS DEFORMED IN VIVO WITH STRUTS RAISED DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174010 ↗
• InjuryJul 28, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BOTH STENTS FAILED TO CROSS THE LESION AND DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 15121653 ↗
• MalfunctionApr 26, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED. IT WAS REPORTED THAT A BALLOON BURST OR LEAK OCCURRED DURING STENT DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207343 ↗
• InjuryApr 5, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  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 EXHIBITING 85% STENOSIS LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT AND THE BALLOON DID NOT INFLATE. IT WAS STATED THAT THE CORONARY WIRE WAS BENT PROXIMALLY AT THE TAIL END AND THERE WERE ISSUES LOADING THE STENT OVER THE BENT WIRE. AFTER THE STENT WAS PLACED OVER THE WIRE INFLATION DIFFICULTIES OCCURRED. THE STENT WAS REMOVED EASILY. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 14013063 ↗
• DeathApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED OF CONGESTIVE SYSTOLIC AND DIASTOLIC HEART AND DIED. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. NOTE ON DEATH CERTIFICATE STATED THAT THE CAUSE OF DEATH COULD ALSO BE ATRIAL FIBRILLATION, CAD AND HYPERTENSION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11640055 ↗
• InjuryMar 26, 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 CX. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED OF MYOCARDIAL INFARCTION OF TARGET VESSEL. THE EVENT WAS TREATED WITH CORONARY INTERVENTION. PATIENT IS RECOVERING.

  Patient problems: Myocardial Infarction; Unspecified Tissue Injury

  MAUDE report 11573772 ↗
• InjuryJan 22, 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 CIRCUMFLEX. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION INVOLVING THE TARGET VESSEL (CX). EVENT WAS TREATED WITH CORONARY ARTERY INTERVENTION AND MEDICATION. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11213848 ↗
• InjuryDec 18, 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, ONE IN THE 1ST DIAGONAL AND ONE IN THE RAMUS. APPROXIMATELY 19 MONTHS POST PROCEDURE THE PATIENT SUFFERED ACUTE ON CHRONIC CONGESTIVE HEART FAILURE WHICH WAS TREATED WITH SALT AND FLUID RESTRICTION, AND DIURESIS. THE INVESTIGATOR AND SPONSOR ASSESSED THE HEART FAILURE AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. DIAGNOSTIC TESTS ALSO SHOWED CORONARY CALCIFICATION WITH CHRONICALLY OCCLUDED 1ST DIAGONAL. TARGET LESION PCI BALLOON ANGIOGRAPHY WAS CARRIED OUT TO TREAT 100% IN- STENT RESTENOSIS OF THE 1ST DIAGONAL. THE INVESTIGATOR AND SPONSOR ASSESSED THE CAD AND OCCLUSION AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11037200 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE THREE RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENTS WERE IMPLANTED IN THE PROX RCA, OB MARG AND THE DISTAL CX. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A FEW EPISODES OF BLOODY STOOLS AND STRAINED TO PASS STOOLS. DAPT WAS TAKEN WITHIN 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE. THE PATIENT IS RECOVERING/RESOLVING.

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

  MAUDE report 10475652 ↗
• MalfunctionApr 15, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX DRUG ELUTING STENT (3.5MM X22 MM) WAS INTENDED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC BALLOON. IT IS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE STENT, AND THE STENT WOULD NOT CROSS. IT WAS REPORTED THAT THE STENT WAS SUBSEQUENTLY DAMAGED. THE LESION WAS AGAIN DILATED WITH ANOTHER NON-MEDTRONIC BALLOON, AND ANOTHER RESOLUTE ONYX STENT (3.5MM X22 MM) WAS SUCCESSFUL IN CROSSING THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962409 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX RX CORONARY DES WERE IMPLANTED IN THE OBTUSE MARGINAL. APPROX 17 MONTHS LATER THE PATIENT SUFFERED NON-STEMI (NON TARGET VESSEL). ANGIO REVEALED 70-80% STENOSIS OF LAD. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE MEDICATION. REVASCULARIZATION WAS CARRIED OUT TO TREAT THE LAD (NON-TVR). THE PATIENT RECOVERED. CEC ADJUDICATED NON-Q-WAVE MI OF TARGET VESSEL, MEDTRONIC EXTENDED HISTORICAL SPONTANEOUS IN THE LAD. CEC ADJUDICATED THAT LATE STENT THROMBOSIS ARC DEFINITE WAS NOTED.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9773580 ↗
• MalfunctionFeb 11, 2020Material Deformation; 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 THE DEVICE KINKED AND FAILED TO CROSS THE LESION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9693909 ↗
• MalfunctionFeb 6, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT THE MID LAD. IT WAS REPORTED THAT THE EDGE OF THE STENT LIFTED FROM THE BALLOON WHEN TRYING TO DELIVER THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9675552 ↗
• InjuryDec 20, 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 USED TO TREAT THE LAD. 26 MONTHS POST INDEX PROCEDURE DURING A REVASCULARISATION PROCEDURE ONE NC EUPHORIA BALLOON CATHETER AND ONE RESOLUTE ONYX DES WERE USED AND PLAQUE SHIFT OCCURRED AND WAS TREATED WITH IMPLANT OF A RESOLUTE ONYX DES.

  Patient problems: Occlusion

  MAUDE report 9503734 ↗
• InjuryNov 20, 2019Adverse 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 LAD. IT WAS REPORTED THAT ON THE SAME DAY THERE WAS A PLAQUE SHIFT FROM THE LAD TO THE 1ST DIAGONAL, POST STENT DEPLOYMENT. THE PATIENT RECOVERED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND CAUSALLY RELATED TO THE DEVICE.

  Patient problems: Occlusion

  MAUDE report 9347107 ↗
• 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 9103922 ↗
• MalfunctionJun 21, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT SEVERELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED USING A 2.0X15MM EUPHORA BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE MID RCA LESION HAD SEVERE ANGULATION PROXIMAL TO THE STENOSIS. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE STENT AND IT WOULD NOT CROSS JUST PROXIMAL TO THE STENOSIS. THE UNDEPLOYED STENT WAS PULLED BACK INTO THE 6F GUIDE CATHETER AND RESISTANCE WAS MET WHEN THE STENT WAS HALF WAY INTO THE GUIDE CATHETER. THE RESISTANCE PREVENTED THE DEVICE FROM BEING PULLED BACK SO ALL THE DEVICES WERE REMOVED TOGETHER. ON INSPECTION IT WAS NOTED THAT SOME OF THE STRUTS WERE LIFTED AND DEFORMED WHICH PREVENTED THE STENT FROM BEEN FULLY RETRIEVED INSIDE THE GUIDE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8721758 ↗
• MalfunctionApr 11, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A HEAVILY CALCIFIED LESION IN THE PROXIMAL RCA. IT IS INDICATED THAT THE STENT FAILED TO CROSS THE LESION. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502872 ↗
• InjuryMar 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, IT WAS INTENDED TO TREAT THE CX WITH A RESOLUTE ONYX STENT BUT THE IMPLANTATION OF THE STENT WAS NOT SUCCESSFUL AND THE STENT WAS REMOVED. POST-PROCEDURE, SUBJECT¿S TROPONIN LEVELS INCREASED 566.67% ABOVE THE PREVIOUS LEVEL AND WAS 45.78 URL. CEC ASSESSED MI AS A NON Q WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL REINFARCTION POST PCI. THE CEC ALSO ADJUDICATED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8381258 ↗
• MalfunctionJan 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS. THE 3.00 X 15MM ONYX WAS USED TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID LAD WITH 80% STENOSIS. THE 3.5 X 22MM ONYX WAS USED TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE MID LEFT MAIN EXHIBITING 50% STENOSIS. THE 3.00 X 15MM ONYX 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 NOT USED. IT WAS REPORTED THAT THE 3.00 X 15MM ONYX DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT IS REPORTED THAT THE STENT DISLODGED OUTSIDE OF THE PATIENT, IT WAS ON THE WIRE OUTSIDE OF THE GUIDE CATHETER. THE 3.5 X 22MM ONYX WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT 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. IT WAS REPORTED THAT THE 3.5 X 22MM ONYX DISLODGED DURING DELIVERY TO/AT THE LESION. THE LEFT M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257352 ↗
• InjuryJan 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION, UPON REMOVAL STENT DISLODGMENT OCCURRED. THE DISLODGED STENT WAS NOT REMOVED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8221355 ↗
• MalfunctionOct 1, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE DISTAL RCA EXHIBITING 95% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. 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 USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE DID NOT CROSS DUE TO CALCIFIED LESION. THE STENT WAS WITHDRAWN INTO THE GUIDE CATHETER AND REMOVED AND A STRUT WAS OBSERVED TO BE LIFTED UP ON THE PROXIMAL END OF THE STENT. ANOTHER ONYX STENT WAS USED SUCCESSFULLY TO TREAT THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7921740 ↗