Resolute Onyx™ RONYX25012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169556799), received between Sep 5, 2017 and Jun 22, 2023 — classified as 8 deaths, 34 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 58 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2023Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS DETAILED THAT A NON-MEDTRONIC STENT WAS UNABLE TO BE DELIVERED SO THE RESOLUTE ONYX STENT WAS THEN USED BUT THE IT DISLODGED IN THE CX. THE DISLODGED STENT WAS FOUND IN THE AORTA AND WAS SUCCESSFULLY REMOVED WITH A SNARE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17179993 ↗
• MalfunctionSep 29, 2022Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. MULTIPLE ATTEMPTS HAD BEEN MADE TO CROSS THE LESION BEFORE THE STENT DISLODGED OFF THE BALLOON. A NEW SMALLER SIZED 1.5MM BALLOON WAS SUCCESSFULLY PUT THROUGH THE UNDEPLOYED STENT AND INFLATED WITH HALF OF THE STENT ON THE BALLOON. THE 1.5MM BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT INTO THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE GUIDE EXTENSION CATHETER AND THE BALLOON WERE THEN REMOVED FROM THE PATIENT WITH THE STENT FULLY INTACT. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. NO FURTHER PATIENT INJURY REPORTED. A SECOND RESOLUTE ONYX STENT (2.5X12MM) AND A EUPHORA CORONARY BALLOON WERE ALSO USED DURING THE PROCEDURE. THERE IS NO COMPLAINT AGAINST THESE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504348 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS AND TWO NON MEDTRONIC STENTS IMPLANTED DURING A PROCEDURE. ADDITIONAL BLOCKAGES WERE NOTED WHICH WERE TREATED WITH MEDICATION. APPROXIMATELY FIVE DAYS LATER THE PATIENT EXPERIENCED CHEST PAIN AND ARM TINGLING ON BOTH SIDES. BOTH SYMPTOMS WENT AWAY ON THE SAME DAY. DURING A FOLLOW UP APPOINTMENT WITH THE CARDIOLOGIST AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED. THE CAUSE OF THE CHEST PAIN COULD NOT BE DETERMINED. ANOTHER MEDICATION WAS PRESCRIBED AND ADDITIONAL TESTS WERE SCHEDULED. THE TESTING PERFORMED WAS THE SINGLE PHOTON EMISSION TOMOGRAPHY (SPECT) MYOCARDIAL PERFUSION IMAGING. THE RESULT DETERMINED THAT WHEN THE STENT WAS PLACED ANOTHER ARTERY WAS RUPTURED, WHICH IS THE REASON FOR THE PAIN. THE CARDIOLOGIST SAID THE PATIENT IS NOT AT RISK FOR A HEART ATTACK. A NON URGENT SURGERY IS NEEDED TO REPAIR THE RUPTURE.

  Patient problems: Chest Pain; Insufficient Information; Rupture

  MAUDE report 14391591 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS AND TWO NON MEDTRONIC STENTS IMPLANTED DURING A PROCEDURE. ADDITIONAL BLOCKAGES WERE NOTED WHICH WERE TREATED WITH MEDICATION. APPROXIMATELY FIVE DAYS LATER THE PATIENT EXPERIENCED CHEST PAIN AND ARM TINGLING ON BOTH SIDES. BOTH SYMPTOMS WENT AWAY ON THE SAME DAY. DURING A FOLLOW UP APPOINTMENT WITH THE CARDIOLOGIST AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED. THE CAUSE OF THE CHEST PAIN COULD NOT BE DETERMINED. ANOTHER MEDICATION WAS PRESCRIBED AND ADDITIONAL TESTS WERE SCHEDULED. THE TESTING PERFORMED WAS THE SINGLE PHOTON EMISSION TOMOGRAPHY (SPECT) MYOCARDIAL PERFUSION IMAGING. THE RESULT DETERMINED THAT WHEN THE STENT WAS PLACED ANOTHER ARTERY WAS RUPTURED, WHICH IS THE REASON FOR THE PAIN. THE CARDIOLOGIST SAID THE PATIENT IS NOT AT RISK FOR A HEART ATTACK. A NON URGENT SURGERY IS NEEDED TO REPAIR THE RUPTURE.

  Patient problems: Chest Pain; Insufficient Information; Rupture

  MAUDE report 14391519 ↗
• MalfunctionFeb 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80-90% STENOSIS IN THE OSTIUM OF THE CIRCUMFLEX (CX) ARTERY PRESENTING ANOMALOUS CIRCUMFLEX OFF OF THE RCA WITH AN ACUTE OSTIAL LESION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASSTHROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE CATHETER WAS KINKED. THE DEVICE ALSO FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT THE DEVICE CATHETER DETACHED DURING DELIVERY THROUGH THE VESSEL. THE STENT WAS NOT DELIVERED AND WAS REMOVED WITH THE STENT DELIVERY SYSTEM FROM THE PATIENT BODY. THE LESION WAS LEFT UNTREATED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422585 ↗
• MalfunctionJan 10, 2022Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A CALCIFIED LESION IN THE MID RCA. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT THE STENT WAS EXPIRED WHEN IT WAS ATTEMPTED TO BE IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203399 ↗
• MalfunctionAug 16, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE OSTIUM OF THE RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX DRUG ELUTING STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324747 ↗
• MalfunctionAug 11, 2021Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PHYSICIAN REPORTED THAT DURING THE PCI, TWO WIRES WERE IN USE AND ONE WIRE HAD A BALLOON WHEN THE RESOLUTE ONYX WAS ATTEMPTED TO ADVANCE OVER THE OTHER WIRE. RESISTANCE WAS NOTED AT THE SUBCLAVIAN PORTION, THE STENT DEVICE WAS STILL IN THE GUIDE WIRE, NOT INTO THE CORONARY VESSELS. THE DEVICE WAS PULLED OUT AND IT WAS NOTED THAT THE STENT STRUTS AND TIP WERE VERY DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX DRUG ELUTING STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305783 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE GRAFT 2ND OBTUSE MARGINAL. TWO DAYS AFTER INDEX PROCEDURE, THE PATIENT UNDERWENT A STAGED PROCEDURE AND THREE RESOLUTE ONYX DES WERE IMPLANTED, TWO IN THE RAMUS AND ONE IN THE LEFT MAIN CORONARY ARTERY. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (NON-TARGET VESSEL). IT IS REPORTED THAT NO TARGET (INDEX PROCEDURE) VESSEL(S) WERE INVOLVED, BUT THE SPECIFIC VESSEL FOR MI INVOLVEMENT IS NOT REPORTED. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 12133352 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX AND LAD. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12056213 ↗
• InjuryFeb 26, 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 07 MONTHS POST PROCEDURE PATIENT SUFFERED NORMOCYTIC ANEMIA. GI BLEEDING WAS SUSPECTED AS THE PATIENT HAD A POSITIVE OCCULT STOOL. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE EVENT WAS TREATED WITH MEDICATION. PATIENT HAS NOT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11384982 ↗
• DeathFeb 22, 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 AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST RPL. A PPROXIMATELY 20 MONTHS POST INDEX PROCEDURE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11357566 ↗
• MalfunctionDec 23, 2020Material Deformation; 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11064235 ↗
• 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 10935404 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT LESIONS IN THE DIAGONAL BRANCH AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT A POSSIBLE DRUG ERUPTION OCCURRED. IT WAS STATED THAT 3 DAYS AFTER HOSPITALISATION THE PATIENT HAD A BLISTERING RASH THAT WRAPPED FROM THE LEFT SPINE TOWARDS THE LEFT HIP AND THAT SINGULAR BLISTERS OCCURRED THAT WERE ERUPTING ON THE PATIENTS NECK, LIMBS AND TRUNK. IT WAS STATED THAT THE PATIENT IS ALSO TAKING SEVERAL NEW MEDICATIONS. THE PATIENT SUFFERS ALLERGIES FROM SULFA AND TYLENOL. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 10926453 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, FOUR RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX. TWO EUPHORA PTCA BALLOON WERE ALSO USED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED CARDIAC ENZYMES. INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED. THE CEC ADJUDICATED THAT A MI OCCURRED IN THE TARGET VESSEL, THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 10894234 ↗
• DeathJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. APPROXIMATELY 20 MONTHS LATER, THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10127349 ↗
• DeathJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. APPROXIMATELY 20 MONTHS LATER, THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10127346 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED BY UNSTABLE ANGINA AND POSITIVE STRESS TEST. DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD. FOLLOWING DAY, PATIENT HAD ELEVATED TROPONIN LEVEL. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO THE STUDY DEVICE BUT NOT RELATED TO THE ANTIPLATELET. CEC ADJUDICATED THE EVENT AS MI (TARGET VESSEL), INVOLVING THE LAD. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 9865676 ↗
• DeathFeb 20, 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. APPROXIMATELY 9 MONTHS POST PROCEDURE, PATIENT SUFFERED CONGESTIVE HEART FAILURE AND DIED. DEATH WAS CLASSIFIED AS A NON-SUDDEN CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 9731647 ↗
• InjuryFeb 11, 2020Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 85% STENOSIS IN THE MID CIRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. STENT WAS EVENTUALLY EXPANDED INTO PLACE WITH A SMALLER BALLOON. IT WAS STATED THAT THE PATIENT CAME BACK NEXT DAY WITH STENT THROMBOSIS. IT WAS ALSO MENTIONED THAT THE STENT COULD BE UNDERSIZED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Thrombus

  MAUDE report 9693160 ↗
• DeathFeb 7, 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 RCA AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION AND DIED ON THE SAME DAY. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE AND ANTIPLATELETS MEDICATION.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 9680717 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA, R-PDA AND LAD. THREE EUPHORA PTA BALLOONS WERE ALSO USED IN THESE VESSELS. APPROXIMATELY 2 WEEKS POST PROCEDURE, PATIENT SUFFERED GASTROENTERITIS WITH CHEST PAIN. SAFETY COMMENTED THAT GI BLEED OCCURRED. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9635921 ↗
• MalfunctionJan 2, 2020Material 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 CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED WITH STRUTS NOTED TO BE LIFTED. THE PROCEDURE WAS COMPLETED USING A 2.5X8MM RESOLUTE ONYX STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537959 ↗
• MalfunctionJan 2, 2020Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS AND NON CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DIFFICULTY OCCURRED WHILE ATTEMPTING TO POSITION THE STENT AND UPON WITHDRAWAL BACK INTO THE GUIDE, STENT DISLODGEMENT OCCURRED. IT WAS DECIDED TO LEAVE THE STENT IN PLACE IN THE RIGHT FEMORAL AREA. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537840 ↗