Resolute Onyx™ RONYX27515UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169556898), received between Sep 25, 2017 and Sep 27, 2023 — classified as 3 deaths, 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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.

• MalfunctionSep 27, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). AN ANGIOPLASTY WITH A NON-MEDTRONIC (MDT) BALLOON WAS ALSO PERFORMED TO THE 1ST DIAGONAL ARTERY. THREE LAUNCHER GUIDE CATHETERS WERE ALSO USED DURING THE PROCEDURE. APPROXIMATELY 11 MONTHS POST PROCEDURE THE PATIENT BEGAN HAVING NEW CHEST PAINS WITH EXERTION AND RELIEVED WITH REST. THREE MONTHS LATER THE PATIENT SAW CARDIOLOGY AND HAD ABNORMAL POSITRON EMISSION TOMOGRAPHY¿COMPUTED TOMOGRAPHY (PET CT) FINDINGS AND WAS BROUGHT IN FOR ANGIOGRAM. THE ANGIOGRAM REVEALED RESTENOSIS IN MID LAD PROXIMAL AND DISTAL TO THE STENT AT INDEX PROCEDURE. IN-STENT RESTENOSIS (ISR) WAS ALSO NOTED IN THE MID RCA. UNDER-EXPANDED STENT WAS ALSO REPORTED. THE RESTENOSIS IN THE LAD WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), INTRAVASCULAR LITHOTRIPSY (IVL), AND STENTING. THE MID RCA ISR WAS TREATED WITH PTCA AND IVL. THE PATIENT WAS REPORTED AS RECOVERING. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO THE DEVICE AND PROCEDURE. THE SPONSOR ASSESSED THE E

  Patient problems: Chest Pain; Insufficient Information; Stenosis

  MAUDE report 17824035 ↗
• InjuryNov 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OM). IT WAS STATED THAT IT WAS A TIGHT LESION WITH RECOIL. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED MULTIPLE TIMES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT COULD NOT REACH THE CORRECT POSITION DUE TO LESION RECOIL AND STENT DISLODGEMENT OCCURRED DURING REMOVAL OF THE DEVICE. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT USING A SNARE BUT WAS UNSUCCESSFUL. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. ATTEMPTS WERE ALSO MADE TO RE-ENGAGE THE STENT WITH A SMALLER BALLOON AND TO WRAP WIRES DISTAL TO THE STENT TO PULL THE SYSTEM OUT BUT THESE WERE ALSO UNSUCCESSFUL. IT WAS STATED THAT AFTER MULTIPLE ATTEMPTS TO REMOVE THE STENT A DISSECTION WAS NOTED IN THE LEFT MAIN (LM). DURING BALLOON PUMP INSERTION THE PATIENT SUFFERED MULTIPLE ARRHYTHMIAS REQUIRING DEFIBRILLATION. THE LM WAS RE-ENGAGED. THE CIRCUMFLEX (C

  Patient problems: Arrhythmia; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 12802068 ↗
• InjuryOct 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT THE STENTS HAVE 100% OCCLUSION AND THE PATIENT WILL NEED A BYPASS SURGERY TO TREAT THE BLOCKED STENTS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12670599 ↗
• InjuryMay 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE MID CX ARTERY WITH 90% STENOSIS. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS REMOVED USING A PTCA BALLOON AND A SNARE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11892327 ↗
• DeathApr 27, 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 LAD. APPROXIMATELY 13 MONTHS POST PROCEDURE PATIENT SUFFERED OF COVID-19 AND DIED DUE TO COMPLICATIONS OF COVID19. THE DEATH IS CLASSIFIED AS UNKNOWN.

  Patient problems: Viral Infection

  MAUDE report 11730900 ↗
• InjuryFeb 16, 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO / AT A LESION. IT WAS STATED THAT THE STENT WAS NOT REMOVED AND A SECOND STENT WAS IMPLANTED OVER THE DISLODGED STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11331796 ↗
• InjuryNov 26, 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 2ND OBTUSE MARGINAL AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. IT WAS REPORTED THAT ON THE SAME DAY POST INDEX PROCEDURE, PATIENT'S CARDIAC ENZYMES WERE ELEVATED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION IN THE 2ND OBTUSE MARGINAL.

  Patient problems: Myocardial Infarction

  MAUDE report 10911746 ↗
• MalfunctionOct 9, 2020Deflation Problem; Deflation Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED. IT WAS REPORTED THAT THE STENT WAS DEPLOYED BUT THE BALLOON DID NOT DEFLATE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10654391 ↗
• InjuryOct 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LAD. A TELESCOPE GUIDE EXTENSION CATHETER WAS ALSO USED. THE RESOLUTE ONYX DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A NON-MEDTRONIC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND AFTER THE THIRD ATTEMPT TO CROSS, STENT DISLODGEMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO PASS A 1.25 MM BALLOON INTO THE STENT ONCE IT WAS FLOATING IN THE LAD BUT WAS UNSUCCESSFUL. A WIRE WAS THEN PUT ALONG SIDE IT BUT THE BALLOON COULD NOT BE PASSED. THE PATIENT WAS PUT ON A BALLOON PUMP AND SENT TO SURGERY. THE STENT REMAINS IN THE PATIENT AND WAS LEFT IN AFTER A SINGLE BYPASS WAS PERFORMED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10618657 ↗
• MalfunctionJul 28, 2020Deflation Problem; Activation, Positioning or Separation Problem

  ELDERLY MALE TO EMERGENCY DEPARTMENT WITH ACTIVE CHEST PAIN. DURING THE HEART CATH, STENT DID DEPLOY BUT THE BALLOON DID NOT DEFLATE. NO KNOWN HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332039 ↗
• MalfunctionJun 23, 2020Device Dislodged or Dislocated; Material Deformation; 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. 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 INSERTION INTO THE HOMEOSTATIC VALVE. IT WAS STATED THAT THE STENT DETACHED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE DISLODGED STENT WAS REMOVED BY RETRACTION FROM THE GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183139 ↗
• InjuryMay 1, 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. APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CHEST PAIN. EVENT WAS CLASSIFIED AS MYOCARDIAL INFARCTION INVOLVING THE TARGET VESSEL (LAD). EVENT WAS TREATED WITH LEFT HEART CATHETERIZATION AND LEFT IN THE HOSPITAL FOR 'WASHOUT' OF ANTICOAGULANT THERAPY PRIOR TO BYPASS SURGERY (2 VESSEL). INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO INDEX DEVICE. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION PATIENT IS RECOVERING.

  Patient problems: Myocardial Infarction

  MAUDE report 10016903 ↗
• DeathMar 3, 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 IMPLANT IN THE CX. APPROXIMATELY 14 MONTHS POST PROCEDURE, PATIENT DEATH OCCURRED. THE DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Death

  MAUDE report 9779207 ↗
• InjuryDec 11, 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 RCA. APPROXIMATELY 6 MONTHS LATER THE PATIENT SUFFERED CVA TREATED WITH HOSPITALIZATION. IT WAS STATED THAT THE EVENT WAS LIKELY HYPOTENSION RESULTING IN ISCHEMIC STROKE. THE PATIENT IS RECOVERING. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 9450636 ↗
• MalfunctionNov 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID-PROXIMAL 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 ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A DETACHMENT OCCURRED AT THE CATHETER DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION WAS REMOVED THROUGH THE GUIDE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9361618 ↗
• InjuryAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. THE STENT WAS LEFT IN THE INTERNAL ILIAC ARTERY. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8887218 ↗
• MalfunctionJun 7, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE PROXIMAL LAD. IT IS INDICATED ON A NON COMPLAINT PRODUCT REPLACEMENT REQUEST FORM THAT THE STENT WAS DEFORMED AND THAT THE STENT WOULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER ONYX 2.6MM X 12MM STENT. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8678003 ↗
• MalfunctionMay 20, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT STENT DEFORMATION OCCURRED AFTER MULTIPLE FAILED ATTEMPTS TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8623036 ↗
• MalfunctionMay 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT TO TREAT A MODERATE TORTUOSITY, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED USING 3 DIFFERENT SIZE SPRINTER BALLOONS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. THE FIRST ATTEMPT TO CROSS THE PROXIMAL CIRCUMFLEX LESION WITH THE RESOLUTE ONYX STENT FAILED. IT WAS REPORTED THAT DURING A SECOND ATTEMPT TO PLACE THE STENT, THE STENT BECAME CAUGHT ON THE EDGE OF THE ENTRY PORT OF THE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND THE STENT CAME OFF THE BALLOON. THE STENT DISLODGED PROXIMALLY TOWARD THE STENT DELIVERY SYSTEM CATHETER SHAFT WHILE INSIDE THE GUIDE CATHETER, PROXIMAL TO THE TELESCOPE ENTRY PORT. AT THAT TIME, THE GUIDE CATHETER WAS INSIDE THE PATIENTS BODY. THE STENT CAME OFF INSIDE THE PATIENT, BUT NOT IN THE PATIENTS ANATOMY AS IT WAS STILL ON THE STENT DELIVERY SYSTEM CATHETER SHAFT, AND PROXIMAL TO THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586761 ↗
• InjuryMar 25, 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 CIRCUMFLEX AND OTHER IN THE LAD. THIRTY-TWO DAYS POST PROCEDURE, NSTEMI OF THE TARGET VESSEL WAS REPORTED AND TREATED WITH MEDICATION AND REVASCULARIZATION WITH A DRUG-ELUTING STENT IMPLANTED IN THE LAD. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE DEVICE AND ANTIPLATELETS. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELETS. PATIENT RECOVERED.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 8447543 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PREVIOUSLY IMPLANTED WITH TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS HAS BEEN EXPERIENCING A FULL BODY RASH SINCE BOTH STENTS WERE IMPLANTED. IT IS INDICATED THAT THE RASH LOOKS LIKE ECZEMA. IT WAS QUERIED IF THE STENT COULD HAVE CAUSED THE RASH. THE PATIENT WAS ADVISED TO CONTACT THEIR PHYSICIAN TO REQUEST A METAL ALLERGY TEST TO DETERMINE IF THEY HAVE A NICKEL ALLERGY. IT IS INDICATED THAT THE PATIENT IS CURRENTLY BEING TREATED FOR THE REACTION.

  Patient problems: Rash; Reaction

  MAUDE report 8423887 ↗
• InjuryMar 14, 2019Adverse 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 1ST DIAGONAL. 3 DAYS POST PROCEDURE THE PATIENT SUFFERED MELENA. PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. EVENT WAS TREATED WITH MEDICATION. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION. PATIENT IS RECOVERING.

  Patient problems: Blood Loss

  MAUDE report 8420234 ↗
• DeathDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A RESOLUTE ONYX CORONARY DRUG ELUTING STENT. THE PATIENT'S FAMILY CALLED, FOLLOWING ADVICE FROM THE PHYSICIAN TO REPORT THAT THE PATIENT HAD DIED APPROXIMATELY 5 MONTHS POST-IMPLANTATION OF THE STENT. THE PATIENT'S FAMILY WAS ASKED IF THE PHYSICIAN FELT THAT THE STENT CONTRIBUTED TO THE PATIENT'S DEATH AND THEY REPLIED "NO, THE PATIENT DIED OF HEART FAILURE.". THE PHYSICIAN REPORTED THAT NO ISSUES WERE ENCOUNTERED DURING THE IMPLANTATION PROCEDURE AND ASSESSED THE DEVICE AND STENT IMPLANTATION AS NOT A CONTRIBUTORY CAUSE TO THE PATIENT'S DEATH.

  Patient problems: Death

  MAUDE report 8189162 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IMPLANTED WITH FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS REPORTS HAVING AN MI APPROXIMATELY TWO MONTHS POST IMPLANTATION. THE PATIENT QUERY'S WHY AN MI OCCURRED POST IMPLANTATION OF THE FOUR STENTS. A GUIDE TO UNDERSTANDING YOUR DES PROCEDURE WAS SENT TO THE PATIENTS ADDRESS.

  Patient problems: Myocardial Infarction

  MAUDE report 8073931 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS ((B)(4)) AND ((B)(4)) WERE IMPLANTED IN THE OSTIUM OF THE RAMUS. THE LESION EXHIBITED MILD CALCIFICATION AND 80% STENOSIS. ARTERY DIAMETER 2.75 X12MM. THERE WAS NO DAMAGED NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE PRODUCTS WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUED NOTED. THE LESION WAS PREDILATED. THE DEVICES 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 APPROXIMATELY 5 DAYS POST IMPLANT THE PATIENT PRESENTED WITH VESSEL OCCLUSION DUE TO INSTENT SUBACUTE THROMBOSIS (REDUCTION IN LEFT VENTRICULAR EJECTION FRACTION FROM NORMAL TO 35%) AND A TARGET VESSEL MYOCARDIAL INFARCTION. PATIENT IS REPORTED TO HAVE BEEN TAKING DAPT. PATIENT STATUS IS ALIVE WITH INJURY.

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7908985 ↗