Resolute Onyx™ RONYX40018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169557178), received between Dec 14, 2017 and Nov 6, 2023 — classified as 2 deaths, 25 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT THE STENT WAS IN THE GUIDE CATHETER. THE DISLODGED STENT WAS REMOVED INSIDE THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077433 ↗
• InjuryJun 27, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL-MID RIGHT CORONARY ARTERY (RCA). THE PROCEDURE WAS A STAGED PCI DUE TO CALCIUM AND COMPLEXITY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING NC BALLOONS AND ORBITAL ATHERECTOMY AT 80RPM. A NON-MEDTRONIC GUIDE WIRE AND GUIDE EXTENSION CATHETER WERE USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. THE STENT FAILED TO CROSS THE LESION SO ORBITAL ATHERECTOMY WAS PERFORMED AGAIN. THE STENT WAS CHECKED FOR DAMAGE BUT NONE WAS NOTED. ANOTHER ATTEMPT TO ADVANCE THE STENT WAS MADE BUT THE STENT DISLODGED PROXIMALLY. THE WIRE WAS STILL IN THE DISLODGED STENT SO A BALLOON TECHNIQUE WAS USED TO REMOVE THE STENT. A 1.5 MM BALLOON WAS PASSED BEYOND THE STENT AND THE ENTIRE SYSTEM (STENT, BALLOON, GUIDE CATHETER) WAS PULLED BACK AS ONE UNIT.

  Patient problems: Insufficient Information

  MAUDE report 14826126 ↗
• InjuryJun 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE RESOLUTE ONYX STENTS WERE INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED. BOTH STENTS DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOTED ADVANCING THE STENTS AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT AN ATTEMPT TO CROSS THE 2.75X38MM RESOLUTE ONYX STENT THROUGH PREVIOUSLY DEPLOYED STENTS FAILED AND DURING REMOVAL OF THE DEVCIE THE STENT BECAME DEFORMED AND DISLODGED IN THE LEFT MAIN. AN ATTEMPT WAS THEN MADE TO DELIVER AND DEPLOY THE 4.0 X 18MM RESOLUTE ONYX STENT AND THIS STENT ALSO DISLODGED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. BOTH STENTS WERE REMOVED USING A SNARE. ATHERECTOMY AND VESSEL PREP WAS COMPLETED AND A 3.0X 38MM RESOLUTE ONYX WAS IMPLANTED IN THE DISTAL LAD. NO FURTHER PATIENT INJURY WAS REPORTED.  TWO NC EUPHORA RX PTCA BALLOON CATHETERS WERE ALSO INTENDED TO BE USED DURING THIS PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE ISSUES NOTED DURING REMOVAL OF THE NC EUPHORA BALLOONS

  Patient problems: Insufficient Information

  MAUDE report 14652646 ↗
• MalfunctionOct 15, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. IT WAS REPORTED THAT THE STENT FAILED TO CROSS AND STENT STRUCTURE DID NOT ADHERE TO THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638221 ↗
• MalfunctionAug 11, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE CX. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND A STENT DISLODGEMENT OCCURRED. THE STENT CAME OFF THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306234 ↗
• DeathMay 11, 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. APPROXIMATELY 25 MONTHS POST PROCEDURE IT WAS FOUND ON THE STUDY EXIT CRF (CASE REPORT FORM) THAT PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 11805545 ↗
• InjuryMar 19, 2021Adverse 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 1ST OBTUSE MARGINAL. APPROXIMATELY 20 MONTHS POST PROCEDURE THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA RELATED TO COVID-19 AND DURING HOSPITALIZATION SUFFERED MYOCARDIAL INFARCTION IN A UNKNOWN VESSEL. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT HAS NOT RECOVERED.

  Patient problems: Myocardial Infarction; Pneumonia

  MAUDE report 11527054 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE THREE RESOLUTE ONYX DES. IT WAS STATED THAT AFTER DEPLOYING THE THREE STENTS THE DISTAL PART OF THE VESSEL LOOKED WORSE AND IT WAS DECIDED TO DEPLOY A FOURTH RESOLUTE ONYX. THE STENT WAS UNABLE TO GET THROUGH SO IT WAS REMOVED, THE PROXIMAL LESION WAS PREDILATED AND THE STENT WAS THEN DEPLOYED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11320720 ↗
• DeathNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED - ONE WAS IMPLANTED IN THE LAD AND ONE WAS IMPLANTED IN THE RCA. APPROXIMATELY 30 MONTHS POST PROCEDURE, PATIENT SUFFERED PRE-EXISTING END STAGE RENAL DISEASE AND DIED THE SAME DAY WHILE IN HOSPICE CARE. THE DEATH WAS CLASSIFIED AS A NON CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED THE EVENT AS CARDIAC DEATH.

  Patient problems: Renal Failure

  MAUDE report 10868144 ↗
• InjuryNov 4, 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 THE STENT WAS CRUSHED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT HAD TO BE TRANSFERRED TO SPECTRUM HEALTH. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY. THE PATIENT WAS DISCHARGED AND WAS REPORTED TO BE DOING WELL.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10783701 ↗
• InjuryAug 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 DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A BILATERAL PULMONARY EMBOLI. THE PATIENT WAS TREATED WITH MEDICATION AND HOSPITALIZATION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Embolism; Embolism/Embolus; Myocardial Infarction

  MAUDE report 10447206 ↗
• MalfunctionMay 15, 2020Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE RESOLUTE ONYX STENT WAS EXPIRED APPROXIMATELY 6 WEEKS AT THE TIME THE STENT WAS IMPLANTED. IT WAS STATED THAT THE USE BY DATE WAS NOT CHECKED PRIOR TO OPENING THE BOX OF THE STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060459 ↗
• InjuryFeb 26, 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 1ST DIAGONAL AND CX. APPROXIMATELY 13 MONTHS POST PROCEDURE, PATIENT SUFFERED NSTEMI IN A TARGET VESSEL (LAD) AND WAS TREATED WITH A RESOLUTE ONYX DES IMPLANTED IN THE 1ST DIAGONAL. INVESTIGATOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT UNLIKELY RELATED TO ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE AND ANTI PLATELET MEDICATION. PATIENT RECOVERED.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 9755865 ↗
• InjuryFeb 14, 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 AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM WORSENING CORONARY ARTERY DISEASE. IT WAS REPORTED THAT THERE WAS A TOTAL OCCLUSION IN THE LAD, PAST THE POINT OF PREVIOUS STENTS. EVENT WAS TREATED WITH MEDICATION. AN UNSUCCESSFUL ATTEMPT WAS MADE TO TREAT THE EVENT WITH TRANSLUMINAL CORONARY ANGIOPLASTY. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT IS NOT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 9710873 ↗
• InjuryOct 24, 2019Adverse 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 DEPLOYED, ONE IN THE FIRST DIAGONAL AND ONE IN THE PROXIMAL CIRCUMFLEX. APPROXIMATELY 10 MONTHS LATER, THE PATIENT PRESENTED WITH UNSTABLE ANGINAL PAIN. ANGIO SHOWED SEVERE IN-STENT RESTENOSIS WITH IN-STENT THROMBUS TO THE VEIN GRAFT SUPPLYING THE FIRST DIAGONAL. THE PATIENT WAS HOSPITALIZED AND REVASCULARIZATION OF THE FIRST DIAGONAL CARRIED OUT. PATIENT RECOVERED. THE SITE ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO THE ANTIPLATELET MEDICATION AND PROBABLY DEVICE RELATED. THE SPONSOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE ANTI PLATELET MEDICATION AND POSSIBLY DEVICE RELATED.

  Patient problems: Injury; Thrombus

  MAUDE report 9233328 ↗
• MalfunctionOct 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX (4.00 X 18) RX CORONARY DRUG ELUTING STENT TO TREAT A BIFURCATION IN THE MID CIRCUMFLEX ARTERY /OBTUSE MARGINAL. THE LESION EXHIBITED 90% STENOSIS, MILD TORTUOSITY AND MILD CALCIFICATION. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS CARRIED OUT PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A 3.5 X 15 RESOLUTE ONYX WAS FIRSTLY IMPLANTED IN THE OSTIUM OF THE OBTUSE MARGINAL. A "CRUSH TECHNIQUE" WAS USED TO DEPLOY THE 3.5 X 15 STENT. A 6F TELESCOPE GUIDE EXTENSION CATHETER WAS THEN ADVANCED TO THE CRUSHED STENT. IT WAS REPORTED THAT THE RESOLUTE ONYX (4.00 X 18) DEVICE WAS ADVANCED HOWEVER WAS UNABLE TO CROSS THE LESION. STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS STUCK IN THE END OF THE 6F TELESCOPE. THE TELESCOPE, GUIDE CATHETER, AND STENT DELIVERY BALLOON WERE WITHDRAWN AS A UNIT OUT OF THE BODY. THE PROCEDURE WAS COMPLETED FOLLOWING RE-WIRING, PRE-DILATION AND THE USE OF KISSING BALLOONS WHICH ENABLED STENT DELIVERY. NO PATIENT INJUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202362 ↗
• InjuryOct 4, 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 GRAFT R-PDA. APPROXIMATELY 6 MONTHS POST PROCEDURE, PATIENT SUFFERED STEMI WHICH IS RELATED TO MYOCARDIAL INFARCTION OF THE TARGET VESSEL RCA. EVENT WAS TREATED WITH AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. 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.

  Patient problems: Myocardial Infarction

  MAUDE report 9155251 ↗
• InjurySep 27, 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; ONE IN THE GRAFT 2ND DIAGONAL. APPROXIMATELY 24 MONTHS POST PROCEDURE, PATIENT DEATH WAS REPORTED. CAUSE OF DEATH IS UNKNOWN. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT IS NOT RELATED TO DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Aneurysm; Death; Thrombus

  MAUDE report 9127576 ↗
• InjuryAug 7, 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 GRAFT RAMUS. APPROXIMATELY ONE MONTH POST PROCEDURE PATIENT SUFFERED ELEVATED TROPONIN WHICH WAS TREATED WITH MEDICATION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTIPLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED DEVICE BUT NOT RELATED TO ANTIPLATELET. CEC ADJUDICATED EVENT AS MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 8869744 ↗
• InjuryAug 7, 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 GRAFT RAMUS. APPROXIMATELY ONE MONTH POST PROCEDURE PATIENT SUFFERED ELEVATED TROPONIN WHICH WAS TREATED WITH MEDICATION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTIPLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED DEVICE BUT NOT RELATED TO ANTIPLATELET. CEC ADJUDICATED EVENT AS MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 8869694 ↗
• 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 DES WERE IMPLANTED IN THE RCA. AFTER THE INDEX PROCEDURE THE PATIENT HAD ST ELEVATION AND CHEST PAIN WHICH RESOLVED AT PRESENTATION TO THE CATH LAB. REVASCULARISATION WAS PERFORMED BY IMPLANTING TWO RESOLUTE ONYX DES IN THE RCA ON THE SAME DAY. CEC ADJUDICATED A NON Q WAVE TARGET VESSEL MI 3RD UDMI PERI-PCI AND THE REVASC AS CLINICALLY DRIVEN TLR.

  Patient problems: Myocardial Infarction

  MAUDE report 8845634 ↗
• 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 DES WERE IMPLANTED IN THE RCA. THE PATIENT SUFFERED A TARGET VESSEL MYOCARDIAL INFARCTION DUE TO IN- STENT RESTENOSIS AND ACUTE THROMBOSIS ON THE SAME DAY AND REVASCULARISATION WAS PERFORMED BY IMPLANTING TWO RESOLUTE ONYX DES IN THE RCA. CEC ADJUDICATED THE MI A NON Q WAVE TARGET VESSEL MI 3RD UDMI PERI-PCI AND THE REVASC AS CLINICALLY DRIVEN TLR.

  Patient problems: Myocardial Infarction

  MAUDE report 8844832 ↗
• MalfunctionJun 17, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A NON- TORTUOUS AND SEVERELY CALCIFIED LESION IN THE MID 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703175 ↗
• InjuryMay 27, 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 GRAFT 1ST OBTUSE MARGINAL. APPROXIMATELY 1 MONTH POST PROCEDURE THE PATIENT SUFFERED NSTEMI, NO ACTION WAS TAKEN. THE PATIENT IS NOT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR INDEX DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE INDEX DEVICE.

  Patient problems: Myocardial Infarction

  MAUDE report 8643959 ↗
• MalfunctionApr 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT A DETACHMENT OCCURRED IN THE CATHETER OF THE DEVICE WHILE ADVANCING THOUGH THE GUIDE CATHETER. IT WAS REPORTED THAT THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE DEVICE WAS NOT USED IN THE PATIENT. THE DEVICE RETURNED WITH A DETACHMENT ON THE HYPOTUBE 90.3 CM DISTAL TO THE STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8554280 ↗