Resolute Onyx™ RONYX30034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169557031), received between Jan 17, 2018 and Jan 12, 2026 — classified as 6 deaths, 19 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Activation, Positioning or Separation Problem

  ANGIOGRAPHY PERFORMED ON A PATIENT WHICH NOTED THAT THE PATIENT HAD A LEFT MAIN (LM) HAD DIFFUSE MILD NON OBSTRUCTIVE CORONARY ARTERY DISEASE. THE LEFT ANTERIOR DESCENDING ARTERY (LAD) HAD 60-70% SMOOTH CALCIFIED MID LAD DISEASE. THE DISTAL VESSEL HAD DIFFUSE MILD DISEASE. THE FIRST DIAGONAL (D1) BRANCH HAD 80-90% NARROWING THROUGHOUT THE OSTIAL AND PROXIMAL VESSEL. THE LEFT CIRCUMFLEX (LCX) GAVE RISE TO A LARGE TORTUOUS FIRST OBTUSE MARGINAL AND CONTINUED IN THE AV GROOVE AS A DIMINUTIVE VESSEL. THERE WAS MODERATE PROXIMAL LCX DISEASE FOLLOWED BY FOCAL MID VESSEL CALCIFIED LESION AND 95% OM1 CALCIFIED LESION. THE RIGHT CORONARY ARTERY HAD 40% DISEASE FOLLOWED BY FOCAL 80% MID VESSEL LESION. THE DISTAL VESSEL HAD DIFFUSE MILD DISEASE. THE PATIENT HAD SEVERE CORONARY ARTERY DISEASE INVOLVING THE LCX , MID LAD, OSTIAL TO PROXIMAL D1 AND MID RCA. GIVEN THE 3 VESSEL CAD, THE DECISION WAS MADE TO PERFORM A PCI TO THE MORSE SEVERE LESION, THE LCX. THE LEFT CORONARY ARTERY WAS ENGAGED WITH A 6F EBU3.5 GUIDE CATHETER. A NON MEDTRONIC WIRE WAS ADVANCED BEYOND THE CULPRIT LESION BY PLACING IT DISTALLY IN THE TORTUOUS OBTUSE MARGINAL WITHOUT COMPLICATION. A 2.5 MM BALLOON WAS POSITIONED ACROS

  Patient problems: Atrial Fibrillation; Dyspnea; Ischemia; Obstruction/Occlusion

  MAUDE report 24035843 ↗
• MalfunctionJun 15, 2023Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Device Dislodged or Dislocated; Entrapment of Device; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; 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 CAME OFF THE BALLOON CATHETER IN THE GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED WITH THE STENT INSIDE. IT WAS ALSO DETAILED THAT THERE WERE TWO WIRES TWISTED IN THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER MEDTRONIC STENT. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134606 ↗
• MalfunctionJun 28, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND BECAME DAMAGED DURING DELIVERY TO THE LESION. A NEW DEVICE OF THE SAME SIZE WAS THEN USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14839708 ↗
• InjuryMar 4, 2022Adverse 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 27 MONTHS POST PROCEDURE PATIENT PRESENTED WITH DIZZINESS, HAD TROPONIN LEVELS ABOVE THE REFERENCE RANGE AND HAD AN ABNORMAL STRESS TEST. SAFETY COMMENTED THAT THE EVENT MAY HAVE BEEN A MYOCARDIAL INFARCTION (MI). PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 13665498 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE CX. APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE ANOTHER RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE CX. APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. THE EVENT WAS TREATED WITH REVASCULARISATION OF THE CX USING A THIRD RESOLUTE ONYX DRUG ELUTING STENT. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 12391922 ↗
• InjuryMay 17, 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 RCA. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE AND APPROXIMATELY 17 MONTHS POST REVASCULARIZATION, CEC ADJUDICATED A TARGET VESSEL MYOCARDIAL INFARCTION OCCURRED INVOLVING THE RCA.

  Patient problems: Myocardial Infarction

  MAUDE report 11830683 ↗
• MalfunctionMay 5, 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 NON-TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE DISTAL LEFT MAIN (LM) CORONARY ARTERY AND CIRCUMFLEX (CX) ARTERY. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE DISLODGED STENT WAS NOT REMOVED AND REMAINED IN THE PATIENT IN THE SMALL BRANCH OF THE PROFUNDA. NO INTERVENTION WAS CARRIED OUT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11776992 ↗
• MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  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 USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER ENDED UP KINKING AND THE SHAFT OF THE DEVICE BROKE AFTER EXCESSIVE FORCE. IT WAS STATED THAT THAT THERE WAS NOT A PROBLEM WITH THE DEVICE AND IT WAS A DIFFICULT LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11550255 ↗
• InjuryMar 19, 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. APPROXIMATELY 33 MONTHS POST PROCEDURE PATIENT SUFFERED CHEST PAIN. PATIENT RECOVERED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION (UNKNOWN VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 11523901 ↗
• InjuryJan 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 RCA. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM TARGET LESION STENT THROMBOSIS AND 100% OCCLUSION OF THE RCA. EVENT WAS TREATED WITH REVASCULARIZATION AND MEDICATION. 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 AND ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 11146398 ↗
• InjuryDec 3, 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 AND AN NC EUPHORA BALLOON WAS USED. CEC ADJUDICATED THAT THE PATIENT SUFFERED A TARGET VESSEL MI INVOLVING THE CIRCUMFLEX ON THE SAME DAY AS THE INDEX PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 10941367 ↗
• DeathDec 2, 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 RCA AND LAD. ONE WEEK LATER AS STAGED PROCEDURE WAS CARRIED OUT AND A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE 1ST OM. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE AND 17 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED MYOCARDIAL INFARCTION OF UNKNOWN TARGET VESSEL AND DIED. DEATH IS CLASSED AS SUDDEN CARDIAC DEATH. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO STUDY DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10935354 ↗
• 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 CX. APPROXIMATELY 24 MONTHS POST PROCEDURE, PATIENT SUFFERED NSTEMI IN THE LAD AND WAS TREATED WITH REVASCULARIZATION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10927235 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT TERM WAS UPDATED TO PROCEDURE RELATED TROPONIN INCREASE WITH AN EVENT DATE OF ONE DAY POST INDEX PROCEDURE. PATIENT RECOVERED. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO INDEX DEVICE BUT NOT RELATED TO ANTIPLATELETS MEDICATION.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 10894880 ↗
• InjuryNov 24, 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. THE SAME DAY, POST IMPLANT, TARGET VESSEL MI WAS ADJUDICATED BY CEC. NO INTERVENTION WAS CARRIED OUT.

  Patient problems: Myocardial Infarction

  MAUDE report 10894868 ↗
• DeathNov 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 LAD. APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, PATIENT WAS ADMITTED WITH ACUTE ON CHRONIC RESPIRATORY FAILURE DUE TO ASPIRATION PNEUMONIA AND MILD INTERSTITIAL LUNG DISEASE. THE PATIENT DIED. DEATH WAS CLASSIFIED AS UNKNOWN AND THE CEC ADJUDICATED THE EVENT AS CARDIAC DEATH. IT WAS REPORTED THAT NO FURTHER DETAILS ARE FORTHCOMING. UPDATE RECEIVED UP TO 11-NOV-2020 WERE ALSO REVIEWED).

  Patient problems: Pneumonia

  MAUDE report 10894651 ↗
• InjuryNov 11, 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 CX. APPROXIMATELY 11 MONTHS LATER THE PATIENT PRESENTED WITH MID-STERNAL ACHING AND CONSTANT CHEST PAIN. THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION AND REVASCULARIZATION OF THE LAD AND CX. THE PATIENT RECOVERED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO ANTI-PLATELET MEDICATION OR THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE DEVICE. CEC ADJUDICATED THE EVENT AS MI INVOLVING THE LAD AND CX (TARGET VESSEL). CEC ADJUDICATED THE REVASCULARIZATION AS TLR PERCUTANEOUS INTERVENTION INVOLVING THE CX AND NON-TVR REVASCULARIZATION INVOLVING THE LAD.

  Patient problems: Myocardial Infarction

  MAUDE report 10822058 ↗
• DeathSep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX DES STENTS WERE IMPLANTED IN THE RCA TO TREAT A CHRONIC TOTAL OCCLUSION. ONE NC EUPHORA BALLOON AND TWO OTHER MEDTRONIC BALLOONS WERE USED DURING THE INDEX PROCEDURE. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE THE PATIENT DIED. THE DEATH WAS CLASSED AS NON SUDDEN CARDIAC DEATH. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND UNLIKELY RELATED TO THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE.

  Patient problems: Death

  MAUDE report 10475807 ↗
• InjuryMay 11, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; 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 MILDLY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED 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 DEFORMATION AND STENT DISLODGEMENT OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT ABNORMALITIES IN RELATION TO THE ANATOMY WERE OBSERVED WHERE THERE WAS A POSTERIOR ORIENTATION OF THE RIGHT CORONARY ARTERY MAKING GUIDE ENGAGEMENT CHALLENGING. IT WAS STATED THAT AS THE STENT WAS BEING POSITIONED IN PROXIMAL RCA, ALL THE WAY TO THE OSTIUM, A PARTIAL INFLATION OF THE DEVICE (1-2ATM) WAS PERFORMED AS THE OPERATOR WANTED TO REPOSITION THE DEVICE. DURING THE ATTEMPT TO REPOSITION THE DEVICE, RESISTANCE WAS EXPERIENCED WHEN MOVING FORWARD AND BACK AND THE GUIDE BACKED OUT INTO THE AORTA. THE STENT CATHETER AND WIRE WAS REMOVED FROM THE RCA. THE STENT WAS NOTED TO BE STRETCHED OUT AND UNRAVELLED BECOMING

  Patient problems: Injury

  MAUDE report 10042134 ↗
• MalfunctionJan 9, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A LESION. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENT. WHEN THE DEVICE WAS REMOVED IT WAS NOTED TO HAVE SOME STRUTS LIFTED. THE PROCEDURE WAS COMPLETED USING ANOTHER 3.00X34MM RESOLUTE ONYX STENT.THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569592 ↗
• DeathDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. THE LESION WAS NON-TORTUOUS, MILDLY CALCIFIED AND HAD 90% STENOSIS. IT WAS REPORTED THAT THE PATIENT DIED FROM A CARDIAC ARREST. NO ALLEGED PRODUCT ISSUE IS REPORTED.

  Patient problems: Death

  MAUDE report 9489364 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE PROMPTED BY AN ACUTE MI TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS, 3.0 X 34MM AND A 3.0 X 15MM, WERE USED TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION EXHIBITING 90% STENOSIS IN THE MID DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH ANY PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT 4-6 HOURS AFTER THE STENTS WERE IMPLANTED STENT THROMBOSIS OCCURRED. TWO ADDITIONAL RESOLUTE ONYX STENTS, 3.0 X 18MM AND A 3.5 X 15MM, WERE USED TO TREAT THE STENT THROMBOSIS IN THE PROXIMAL RCA. IT WAS REPORTED THAT A DISSECTION OCCURRED IN THE PROXIMAL RCA ABOVE THE 3.00X15MM RESOLUTE ONYX STENT. IT WAS STATED THAT IT WAS UNKNOWN IF THE DISSECTION WAS CAUSED BY A STENT OR DUE TO ANATOMY. THE PATIENT IS STABLE AND DOING WELL IN ICU.

  Patient problems: Thrombus; Vascular Dissection

  MAUDE report 9374952 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY EVIDENCE OF ISCHEMIA AND STABLE ANGINA. DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX RX CORONARY DES WERE IMPLANTED IN THE LAD. POST PROCEDURE ANGIO REVEALED 100% STENOSIS IN THE 1ST DIAGONAL. IT IS UNKNOWN IF ANY INTERVENTION WAS CARRIED OUT TO TREAT THE STENOSIS.

  Patient problems: Occlusion

  MAUDE report 9257708 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. 6 DAYS POST INDEX, THE PATIENT SUFFERED NSTEMI, THE TARGET VESSEL WAS NOT INVOLVED. IT WAS REPORTED THAT THE 2ND DIAGONAL VESSEL WAS OCCLUDED BUT NO PCI WAS CARRIED OUT. THE PATIENT WAS TREATED WITH MEDICATION FOR SHORTNESS OF BREATH. THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR ANTI-PLATELET DRUG.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9201726 ↗
• MalfunctionApr 15, 2019Inadequacy of Device Shape and/or Size; Material Deformation; Inadequacy of Device Shape and/or Size; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUE NOTED. THE LESION WAS PREDILATED. 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 IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT IS STATED THAT THE PHYSICIAN PUT THE STENT IN AND REALISED IT WAS A LITTLE SHORT AND WHEN REMOVING THE DEVICE A STRUT WAS NOTED TO BE LIFTED ON ONE END. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8513209 ↗