Resolute Onyx™ RONYX35015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00643169557079), received between Jun 20, 2017 and Dec 18, 2025 — classified as 6 deaths, 27 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, DIFFICULTY WAS ENCOUNTERED ADVANCING STENT. THE GUIDE WIRE CAME BACK FROM ACROSS LESION AND WHILE REPOSITIONING, THE STENT CAME LOOSE FROM DELIVERY SYSTEM. ALL WIRES AND CATHETERS WERE IMMEDIATELY REMOVED, BUT THE STENT COULD NOT BE LOCATED VISUALLY OR VIA FLUOROSCOPY IN THE CATHETER. IT IS BELIEVED THAT THE DISLODGED STENT TRAVELED TO UNKNOWN LOCATION IN BODY SUCH AS THE HEAD OR NECK. THE STENT COULD NOT BE FOUND. THE PATIENT HAS HAD ISSUES SINCE THE EVENT AND IS CURRENTLY INTUBATED IN THE ICU. THE LESION BEING TREATED WAS IN THE CIRCUMFLEX ARTERY (CX). 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 ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PATIENT IS ALIVE WITH INJURY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 23838373 ↗
• 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 15585728 ↗
• MalfunctionAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT, A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. 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 HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202110 ↗
• MalfunctionJun 13, 2022Component Missing; Component Missing

  DURING A PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. DAMAGE WAS NOT NOTED TO THE PACKAGING. THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THERE WAS NO STENT ON THE DELIVERY BALLOON. THE STENT WAS NOTED TO BE MISSING FROM THE BALLOON CATHETER UPON REMOVAL OF THE DEVICE FROM THE HOOP. THE PHYSICIAN STATED THAT NO STENT WAS ON THE BALLOON PRIOR TO USE BUT THE BALLOON WAS USED ON THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674382 ↗
• MalfunctionMay 20, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE TELESCOPE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE STENTS WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED.  IT WAS REPORTED THAT THE FIRST RESOLUTE ONYX STENT (3.50X15MM) BECAME LODGED WITHIN THE INNER DIAMETER OF THE TELESCOPE GEC. THE PHYSICIAN THEN PULLED THE STENT AND TELESCOPE OUT TO START OVER AGAIN. TWO OTHER RESOLUTE ONYX STENTS WERE ATTEMPTED TO BE USED BUT FAILED TO CROSS THE LESION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460720 ↗
• InjuryApr 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A 3.5 X 15MM RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD AN ABNORMALITY IN ANATOMY, A SHEPHERD'S CROOK. 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 USED DURING DELIVERY. FIRST, A 3.50 X 30MM RESOLUTE ONYX WAS SUCCESSFULLY DEPLOYED DISTAL TO THE LESION. IT WAS REPORTED THAT WHEN ATTEMPTING TO ADVANCE THE 3.5 X 15MM RESOLUTE ONYX, DIFFICULTY WAS ENCOUNTERED PLACING THE STENT IN THE CORRECT SPOT TO OVERLAP THE STENT. THE DEVICE WAS ADVANCED BACK AND FORTH AND IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE BALLOON CATHETER. A 2.0 MM BALLOON WAS ADVANCED INTO THE STENT TO OPEN IT AND A 3.5MM NON COMPLIANT BALLOON WAS THEN USED TO COMPLETELY DEPLOY THE STENT WHERE IT HAD DISLODGED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13994601 ↗
• InjuryMar 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION IN THE OSTIUM OF THE CIRCUMFLEX (CX). A NON-MEDTRONIC GUIDE WIRE WAS USED. THE LESION WAS PRE-DILATED A FEW TIMES USING A 3.0X15MM EUHPORA BALLOON. IVUS WAS ALSO USED. THE STENT FAILED TO CROSS THE LESION. MORE EUPHORA BALLOONS WERE USED. IT WAS REPORTED THAT ON THE THIRD ATTEMPT TO PASS THE STENT, STENT DISLODGEMENT OCCURRED IN THE LEFT MAIN (LM) AND CX. THE PHYSICIAN PASSED A 2.0X12MM EUPHORA BALLOON THROUGH THE DISLODGED STENT AND INFLATED IT. A NON-MEDTRONIC STENT WAS ATTEMPTED TO BE USED TO COVER THE LESION BUT FAILED TO CROSS. ANOTHER RESOLUTE ONYX STENT WAS ABLE TO CROSS THE DISLODGED STENT AND WAS DEPLOYED. A 4.0X12MM NC EUPHORA BALLOON WAS USED TO DILATE BOTH STENTS. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13790897 ↗
• InjuryMay 24, 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. A FORTH RESOLUTE ONYX DES WAS ALSO IMPLANTED . 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 11869490 ↗
• DeathMar 29, 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 AND ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11580789 ↗
• InjuryFeb 23, 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, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE RCA. APPROXIMATELY 15 MONTHS, POST INDEX PROCEDURE, THE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION IN THE RCA WITH NEW STENOSIS IN THE LAD AND RCA AND 99% STENOSED IN THE RPA. EVENT WAS TREATED WITH 1 DES STENT IMPLANTED IN THE R-PAV. EVENT IS NOT RESOLVED.

  Patient problems: Myocardial Infarction

  MAUDE report 11364437 ↗
• InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT PLACED IN THE PROXIMAL LEFT MAIN CORONARY ARTERY. THE PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE PATIENT EXPERIENCED A UNIQUE REACTION IN THE FORM OF SIGNIFICANT PAIN IMMEDIATELY AFTER THE PROCEDURE AND WAS TREATED WITH MORPHINE AND FENTANYL. THE PATIENT STATES HAVING HAD CONSISTENT AND PERSISTENT DAILY CHEST PAIN SINCE THE PROCEDURE. THE PATIENT HAS BEEN HOSPITALIZED MULTIPLE TIMES SINCE THE PROCEDURE FOR CHEST PAIN. THE PATIENT RECEIVED FOUR ANGIOGRAMS, CT SCANS, MRI ON SHOULDER AND NECK, AND SCANS WERE CLEAR. THE PATIENT HAS ALSO BEEN CLEARED FROM A GASTROINTESTINAL TEAM. THE PATIENTS CARDIOLOGIST DOES NOT BELIEVE THE PATIENTS SENSITIVITY TO NICKEL AND IRIDIUM COULD BE THE ISSUE. HOWEVER, IT WAS LATER REPORTED BY AN ADDITIONAL PHYSICIAN THAT A UNIQUE REACTION INVOLVING CHEST PAIN COULD NOT BE RULED OUT AND WILL BE INVESTIGATED. ACCORDING TO THE PATIENTS PHYSICIAN: INTRAVASCULAR ULTRASOUND (IVUS) IMAGING AND FRACTIONAL FLOW RESERVE (FFR) WERE CONDUCTED POSTOPERATIVE AND THE STENT IS FULLY EXPANDED AND APPOSED. THERE ARE NO VISIBLE ISSUES WITH THE STENT AND THERE WERE NO COMPLICATIONS WITH THE STENT DURING THE INI

  Patient problems: Chest Pain; Local Reaction; Unspecified Tissue Injury

  MAUDE report 11348374 ↗
• MalfunctionNov 23, 2020Detachment 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. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE CATHETER DETACHED DURING ADVANCEMENT THOUGH THE GUIDE CATHETER. IT WAS STATED THAT WHEN ATTEMPTING TO PLACE THE STENT AND WHEN ADVANCING THE STENT INTO THE BODY AND TRYING TO CROSS A LESION, THE SHAFT PORTION OF THE CATHETER THAT WAS OUTSIDE OF THE BODY, BROKE IN TWO. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10884218 ↗
• InjurySep 3, 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 TO TREAT A LESION. CEC ADJUDICATED THAT THE PATIENT SUFFERED MYOCARDIAL INFARCTION IN THE CIRCUMFLEX (TARGET VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 10486938 ↗
• MalfunctionAug 28, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT DELIVERY OF THE STENTS WAS NOT POSSIBLE AND UPON REMOVAL OF THE DELIVERY SYSTEM, STRUT DAMAGE WAS EVIDENT TO BOTH STENTS. THE PROCEDURE WAS COMPLETED USING NON-MEDTRONIC STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464284 ↗
• InjuryJan 17, 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 LAD. DURING A REVASCULARIZATION, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER TWO RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS , PATIENT SUFFERED NSTEMI IN THE RCA. THE EVENT WAS TREATED WITH TWO RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA AND THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9602163 ↗
• InjuryJan 17, 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 LAD. DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS, PATIENT SUFFERED NSTEMI IN THE RCA. EVENT WAS TREATED WITH 2 RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA. SHORTLY AFTER PROCEDURE PATIENT BECAME SHORT OF BREATH, EKG SHOWED STEMI AND WAS TREATED WITH ANOTHER PCI. PATIENT RECOVERED. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9602049 ↗
• InjuryJan 10, 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 2 MONTHS POST INDEX PROCEDURE, DURING A SECOND REVASCULARIZATION PATIENT SUFFERED FROM OCCLUSION CAUSED BY A PLAQUE SHIFT INTO PREVIOUSLY STENTED SUB BRANCH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Occlusion

  MAUDE report 9574088 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE PATIENT HAD ONE RESOLUTE ONYX STENT IMPLANTED IN THE LAD. IT WAS REPORTED THAT A STENT PINCH OF SIDE BRANCH OCCURRED AFTER IMPLANT REQUIRING BALLOONING. AFTER THE STENT WAS IMPLANTED IN THE LAD THERE WAS A 95% OCCLUSION OF THE 1ST DIAGONAL.

  Patient problems: Occlusion

  MAUDE report 9327828 ↗
• MalfunctionNov 12, 2019Material Deformation; Material Deformation

  IT WAS INDICATED THAT A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT FAILED TO CROSS A LESION AND A STENT STRUT BECAME DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310294 ↗
• MalfunctionOct 30, 2019Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE STENT DID NOT DEPLOY, THE STENT GOT PUSHED BACK PROXIMAL TO THE BALLOON ON THE SHAFT OF THE DELIVERY SYSTEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254946 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX RX CORONARY DES WAS IMPLANTED IN THE CX ARTERY. APPROX SIX WEEKS LATER THE PATIENT SUFFERED PROBABLE ACUTE TYPE 2 NON-ST ELEVATION MYOCARDIAL INFARCTION DUE TO SUPPLY-DEMAND MISMATCH. THE PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR TO THE ANTI PLATELET MEDICATION. 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 9075515 ↗
• MalfunctionAug 27, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE DISTAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENT WAS UNABLE TO DEPLOY AND WAS REMOVED INTACT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8935321 ↗
• DeathAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. IT WAS REPORTED THE PATIENT DIED. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 8868576 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE CX. APPROX 3 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED NSTEMI OF UNKNOWN VESSEL AND WAS TREATED WITH MEDICATION. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY TO THE DEVICE. THE PATIENT IS NOT RECOVERED. [UPDATES 15 AND 24 JUL 19 REVIEWED.]

  Patient problems: Myocardial Infarction

  MAUDE report 8854158 ↗
• DeathAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE CX. APPROX 3 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED ACUTE HYPOXIC RESPIRATORY FAILURE. 7 DAYS LATER THE PATIENT DIED (SUDDEN CARDIAC DEATH). THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 8850413 ↗