Resolute Onyx™ RONYX27518UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169556904), received between Aug 28, 2017 and Feb 3, 2023 — classified as 3 deaths, 14 injuries, 14 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Premature Activation; Device Dislodged or Dislocated; Premature Activation; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. DURING APPOSITION TO THE CIRCUMFLEX ARTERY, THE STENT DEPLOYED AND STAYED INSIDE THE GUIDE EXTENSION CATHETER. THE DISLODGED STENT WAS REMOVED INSIDE THE GUIDE EXTENSION CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16290778 ↗
• MalfunctionDec 22, 2022Material Deformation; Material Deformation

  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 NOT PERFORMED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032272 ↗
• InjuryMay 17, 2022Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED (90%) LESION EXHIBITING 95-99% STENOSIS, LOCATED IN THE PROXIMAL OBTUSE MARGINAL 2. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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. IT WAS REPORTED THAT ON STENT DEPLOYMENT A STRUT FRACTURE OCCURRED DUE TO THE HEAVILY CALCIFIED VESSEL AND LARGE AMOUNT OF CALCIUM DEPOSITS IN THE VESSEL. THE FRACTURE WAS NOTED ON PICTURES FOLLOWING THE WITHDRAWAL OF THE STENT BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 14424650 ↗
• MalfunctionApr 29, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. 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 NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT DURING AN ATTEMPT TO POSITION THE STENT SOME RESISTANCE WAS NOTED. THE STENT WAS REMOVED AND A STRUT WAS NOTED TO BE LIFTED. IT IS BELIEVED THAT THE STENT MAY HAVE COME OUT OF THE HOOP LIKE THAT. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX RX STENT OF THE SAME SIZE. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247813 ↗
• InjuryMar 21, 2022Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size; Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A NON-TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE MID-DISTAL RCA WAS PRE-DILATED WITH A SEMI COMPLIANT BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY.  IT WAS REPORTED THAT THE FIRST STENT WAS DEPLOYED AND THEN MIGRATED TO THE PROXIMAL RCA. THE MIGRATED STENT WAS THEN POST-DILATED AND SECURED USING AN NC BALLOON. THE SECOND STENT WAS DEPLOYED IN THE ORIGINAL LESION SITE BUT THIS STENT ALSO MIGRATED, DISTALLY. BOTH STENTS WERE SECURED AFTER SUCCESSIVE NC DILATION. A THIRD RESOLUTE ONYX STENT WAS THEN PLACED BETWEEN THE FIRST TWO STENTS. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 13840063 ↗
• InjuryMar 21, 2022Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size; Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A NON-TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE MID-DISTAL RCA WAS PRE-DILATED WITH A SEMI COMPLIANT BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY.  IT WAS REPORTED THAT THE FIRST STENT WAS DEPLOYED AND THEN MIGRATED TO THE PROXIMAL RCA. THE MIGRATED STENT WAS THEN POST-DILATED AND SECURED USING AN NC BALLOON. THE SECOND STENT WAS DEPLOYED IN THE ORIGINAL LESION SITE BUT THIS STENT ALSO MIGRATED, DISTALLY. BOTH STENTS WERE SECURED AFTER SUCCESSIVE NC DILATION. A THIRD RESOLUTE ONYX STENT WAS THEN PLACED BETWEEN THE FIRST TWO STENTS. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 13840052 ↗
• MalfunctionJun 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS STATED THE UPON DELIVERY OF THE STENT THROUGH THE NON-MEDTRONIC GUIDE CATHETER, THE PHYSICIAN FELT SOME RESISTANCE OR ¿CATCHING¿ AS IT PASSED TO THE LESION SITE. ONCE AT THE LESION SITE, THE PHYSICIAN NOTICED THE STENT WAS NOT COMPLETELY LINED UP WITH THE STENT DELIVERY SYSTEM BALLOON. THE PHYSICIAN THEN DECIDED TO DEPLOY THE STENT AT THE LESION AND POST-DILATED THE PORTION THAT WAS NOT DEPLOYED WITH GOOD RESULTS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048428 ↗
• MalfunctionApr 7, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL RCA. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PREDILATED. BOTH DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENOSED STENT. BOTH DEVICES EXPERIENCED RESISTANCE DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT BOTH DEVICES FAILED TO CROSS THE LESION AND STENT DEFORMATION IN VIVO DURING POSITIONING OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626212 ↗
• InjuryJan 25, 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 1ST DIAGONAL. APPROXIMATELY 05 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION INVOLVING THE CX (TARGET VESSEL). EVENT WAS TREATED WITH 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 11222005 ↗
• MalfunctionDec 3, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). 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. IT WAS REPORTED THAT THE RESOLUTE ONYX BALLOON BURST BEFORE REACHING THE RATED BURST PRESSURE DURING STENT DEPLOYMENT. IT WAS STATED THAT THERE WAS NO CALCIUM DUE TO ORBITAL ATHERECTOMY BEINGUSED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10940472 ↗
• DeathOct 29, 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 MODERATELY TORTUROUS, HIGHLY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS WAS IN CONJUNCTION WITH A TAVR INTERVENTION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED BEFORE USE. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED WITH A CORONARY 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER ENCOUNTERING SIGNIFICANT CALCIUM. IT WAS STATED THAT THE STENT BECAME LODGED IN THE TIGHT, HIGHLY CALCIFIED LESION. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE STENT DELIVERY SYSTEM, THE STENT CAME OFF THE DELIVERY SYSTEM BALLOON AND REMAINED UNEXPANDED AND UNDEPLOYED IN THE PATIENT. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE THE UNDEPLOYED STENT. INITIALLY, A SMALL NON-MEDTRONIC BALLOON WAS USED TO TRY TO R

  Patient problems: Death; Injury; Insufficient Information; Vascular Dissection

  MAUDE report 10755451 ↗
• DeathSep 7, 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. ONE IN THE RCA AND THE OTHER IN THE LCX. APPROXIMATELY 15 MONTHS POST PROCEDURE, PATIENT EXPIRED. DEATH CLASSIFICATION IS UNKNOWN. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death; Insufficient Information; Respiratory Failure

  MAUDE report 10498965 ↗
• MalfunctionAug 4, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80% LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A 2.0 SEMI-COMPLIANT 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT RESISTANCE WAS FELT. THE STENT WAS REMOVED AND DEFORMATION TO THE STENT WAS NOTED. THE PROCEDURE WAS COMPLETED BY A SECOND PRE-DILATION USING AN NC EUPHORA BALLOON AND ANOTHER RESOLUTE ONYX STENT OF THE SAME SIZE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 10360813 ↗
• InjuryMay 6, 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 14 MONTHS POST PROCEDURE, PATIENT SUFFERED RECTAL BLEEDING AND MEDICATION WAS CHANGED. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT PROBABLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 10028160 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE CX AND ONE IN THE LAD. APPROXIMATELY 7 MONTHS LATER THE PATIENT SUFFERED MI OF THE LAD AND CX TREATED WITH HOSPITALIZATION AND NITROGLYCERIN. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE 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.

  Patient problems: Myocardial Infarction

  MAUDE report 9852300 ↗
• InjuryMar 16, 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: ONE IN THE CX AND ONE IN THE LAD. APPROXIMATELY SEVEN MONTHS POST PROCEDURE, PATIENT SUFFERED CORONARY ARTERY DISEASE. PATIENT HAD SEVERE THREE VESSEL (RCA,LCX AND LAD) CAD/AORTIC STENOSIS AND CABG WAS CARRIED OUT TO TREAT THE STENOSIS. IN STENT STENOSIS WAS REPORTED IN THE CX AND LAD. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATION. CEC ASSESSED EVENT IS A NON-Q WAVE MI OF TARGET VESSEL, 3RD UDMI SPONTANEOUS. CEC ALSO ADJUDICATED THE REVASCULARISATION AS TL CABG CLINICALLY DRIVEN REVASCULARIZATION OF THE CX AND LAD AND NON-TARGET VESSEL SURGERY, CLINICALLY DRIVEN REVASCULARISATION OF THE RCA.

  Patient problems: Myocardial Infarction

  MAUDE report 9834281 ↗
• MalfunctionFeb 19, 2020Inflation Problem; Activation Problem; Inflation Problem; Activation Problem

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS USED TO TREAT A DE NOVO LESION IN THE 1ST DIAGONAL . IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE DEPLOYED AND IT WAS SUBSEQUENTLY REMOVED INTACT. IT WAS THEN REUSED, BEING DEPLOYED AT 10 ATM FOR 10 SECONDS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9726325 ↗
• InjurySep 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY. TWO WIRES WERE INSERTED INTO THE RCA. WHEN THE STENT DELIVERY SYSTEM WAS PULLED BACK, THE STENT CAME OFF THE BALLOON IN THE PATIENT. A BALLOON WAS USED TO SMASH THE STENT AGAINST THE WALL. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 8955611 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A CONCENTRIC, CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS AND THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8938971 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT PREVIOUSLY IMPLANTED WITH TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS REPORTS EXPERIENCING A RASH ON THE FACE SINCE HAVE THE STENTS IMPLANTED. IT WAS QUERIED IF THE RASH IS A REACTION TO THE STENTS. THE PATIENT STATED THAT THEY ARE FOLLOWING UP WITH AN ALLERGIST. THE PATIENT WAS ADVISED TO CONSULT WITH THEIR ALLERGIST AS PLANNED AND TO ARRANGE TESTING WITH THE ALLERGIST TO SEE IF THEY ARE ALLERGIC TO ANY COMPONENTS IN THE STENTS.

  Patient problems: Reaction

  MAUDE report 8826930 ↗
• MalfunctionMay 27, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AND ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT TO TREAT A LESION. IT IS INDICATED ON A NON COMPLIANT PRODUCT REPLACEMENT REQUEST FORM THAT STENT DEFORMATION OCCURRED TRYING TO CROSS THE LESION. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643927 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO STENT WERE IMPLANTED - ONE INTO THE CX AND ONE INTO THE RCA. ON THE SAME DAY. THE PATIENT SUFFERED CHEST PAIN AND WAS TREATED WITH MEDICATION. PATIENT REPORTED TO HAVE RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLE RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION. CEC ADJUDICATED A NON Q-WAVE MI IN THE TARGET VESSEL, 3RD UDMI PERI-PCI.

  Patient problems: Myocardial Infarction

  MAUDE report 8639763 ↗
• InjuryApr 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE LESION WAS HIGHLY CALCIFIED AND AFTER TRYING TO REMOVE THE DEVICE, THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS REMOVED FROM THE ILIAC USING A SNARE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 8563923 ↗
• DeathApr 17, 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. 2 DAYS POST PROCEDURE PATIENT DIED. NO ACTION WAS TAKEN. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR INDEX DEVICE.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 8523173 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE OM1. POST PROCEDURE ELEVATED TROPONIN WAS OBSERVED. CEC ADJUDICATED Q-WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI, Q-WAVE MI (TARGET VESSEL), SCAI DEFINITION PERI-PCI AND ADJUDICATED STENT THROMBOSIS NO EVENT. IT IS REPORTED THAT THE MI OCCURRED IN THE TARGET VESSEL - THE RCA, AND ALSO IN THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 8338523 ↗