Resolute Onyx™ RONYX20022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169556669), received between Aug 23, 2018 and Aug 29, 2025 — classified as 3 deaths, 10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING DELIVERY TO THE LESION. BALLOON ANGIOPLASTY WAS PERFORMED AND THE STENT WAS IMPLANTED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920694 ↗
• InjuryJul 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION. IT WAS REPORTED THAT BOTH STENTS DISLODGED PRIOR TO DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 15051813 ↗
• DeathApr 5, 2022Device 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 NON-TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL/MID RIGHT CORONARY ARTERY (RCA). 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS NOTED THAT THERE WAS AN OLD STENT IN THE RCA. IT WAS VERY DIFFICULT TO TRY AND PLACE THE NEW STENT AND THERE WAS RESISTANCE. THE STENT COULD NOT PASS THE LESION AND ON AN ATTEMPT TO REMOVE THE STENT IT CAUGHT ON THE GUIDE MOST LIKELY DUE TO A LIFTED STRUT AND DISLODGED. IT WAS STATED THAT THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND DEPLOYED IN PART OF THE LESION USING A BALLOON. ANOTHER STENT WAS REQUIRED TO BE DEPLOYED MORE PROXIMAL IN THE LESION TO COMPLETE THE INTERVENTION. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE STENTS DEPLOYED AND THE RESULT WAS GREAT. FOLLOWING THE INTERVENTIO

  Patient problems: Insufficient Information; Ventricular Fibrillation

  MAUDE report 14013229 ↗
• InjuryFeb 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS.  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.  IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION.  A 1.5MM BALLOON WAS INSERTED AND INFLATED IN DISLODGED STENT TO DEPLOY IT. A SECOND 2.25MM BALLOON WAS USED TO POST-DILATE THE STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13591085 ↗
• InjurySep 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION, WITH 95% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN 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 PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING DELIVERY. THE STENT WAS NOT REMOVED, BUT WAS CRUSHED. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 12545835 ↗
• InjuryJan 28, 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 TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS AND M ODERATELY CALCIFIED LESION IN THE MID LAD WITH 100% STENOSIS. THE PATIENT WAS ON COUMADIN DUE TO ATRIAL FIBRILLATION. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED FOR BOTH DEVICES. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. AFTER THE PCI, THE PATIENT DEVELOPED A GASTRIC BLEED AFTER THE STENT WAS IMPLANTED. A DECISION WAS MADE NOT TO START THE ANTIPLATELET MEDICATION FOR 2 DAYS AFTER THE PCI. SEVERAL DAYS LATER, THE PATIENT DEVELOPED CHEST PAIN AND A SUBSEQUENT HEART CATHETHERISATION SHOWED STENT THROMBOSIS. THE THROMBOSIS WAS REMOVED AND THE STENTS WERE BALLOONED AND THE PATIENT WENT ON DAPT (ASPIRIN AND PLAVIX), THE PATIENT IS DOING FINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Chest Pain; Hemorrhage/Blood Loss/Bleeding; Thrombosis/Thrombus

  MAUDE report 11242949 ↗
• DeathNov 20, 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE OSTIUM OF THE DIAGONAL BRANCH. IT WAS STATED THAT THE AREA WAS OF HEAVY CALCIUM BURDEN. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THERE WAS NO RESISTANCE DURING THE OF THE DEVICE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE STENT WITH A SNARE BUT THE SNARE COULD NOT FIT THROUGH THE GUIDE CATHETER. THE STENT WAS UNABLE TO BE RETRIEVED AND THE PATIENT LATER HAD A BYPASS SURGERY. PATIENT IS REPORTED TO BE ALIVE WITH NO FURTHER INJURY POST SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 10874264 ↗
• MalfunctionJul 31, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE. THERE WAS NO ISSUE REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES .RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE STENT DEFORMED IN VIVO DURING POSITIONING. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 10349457 ↗
• MalfunctionMay 28, 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 MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) 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 THE STENT IMPLANTED DURING THE PROCEDURE WAS EXPIRED BY ONE DAY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10096242 ↗
• InjuryFeb 20, 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 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM RIGHT LUNG PULMONARY EMBOLISM . EVENT WAS TREATED WITH MEDICATION AND IVC FILTER WAS PLACED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT PROBABLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT IS NOT RECOVERED.

  Patient problems: Embolism

  MAUDE report 9732277 ↗
• InjuryFeb 18, 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 N THE R-PDA. ONE RESOLUTE ONYX DES WAS INTRODUCED INTO THE GUIDE CATHETER BUT NOT IMPLANTED. APPROXIMATELY 9 MONTHS POST PROCEDURE PATIENT SUFFERED DEMAND ISCHEMIA. PATIENT IS RECOVERING. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9719722 ↗
• 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 DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 10 MONTHS LATER THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 9680765 ↗
• MalfunctionJan 6, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. IT WAS REPORTED THAT WHILE ATTEMPTING TO CROSS THE LESION RESISTANCE WAS MET AND THEREFORE THE STENT WAS REMOVED. WHEN THE STENT WAS REMOVED FROM THE PATIENT THE STENT WAS NOTED TO BE DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553009 ↗
• MalfunctionDec 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED OUTSIDE OF THE BODY AFTER MULTIPLE ATTEMPTS TO CROSS HEAVY CALCIUM. NO OTHER STENT WAS ABLE TO CROSS, JUST A BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9487247 ↗
• InjuryNov 22, 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 MILDLY TORTUOUS, MILDLY CALCIFIED LESION LOCATED IN THE PROXIMAL OSTIUM OF THE DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. 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 TO/AT THE LESION. THE DISLODGED STENT WAS BALLOONED IN PLACE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9361645 ↗
• MalfunctionOct 24, 2019Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT DURING STENT DEPLOYMENT AN ATTEMPT WAS MADE TO INFLATE THE STENT DELIVERY BALLOON AND IT WAS NOTED THAT IT WAS UNABLE TO INFLATE. THE BALLOON WAS ALSO NOTED TO RUPTURE. THE STENT AND DELIVERY SYSTEM WERE REMOVED SUCCESSFULLY FROM THE PATIENT WITHOUT ISSUE OR HARM. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9232658 ↗
• MalfunctionOct 11, 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. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND ON INSPECTION UPON REMOVAL, THE STENT WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179516 ↗
• InjuryAug 21, 2019Adverse 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. AT AN UNKNOWN DATE, PATIENT SUFFERED STROKE. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE AND ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 8914491 ↗
• MalfunctionMay 23, 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 NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE MID CX ARTERY WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DEVICE WAS PULLED INTO THE GUIDE CATHETER AND RESISTANCE WAS FELT, THEREFORE THE GUIDE CATHETER, GUIDEWIRE AND STENT DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637109 ↗
• MalfunctionJan 16, 2019Material Deformation; Material Deformation

  THE PATIENT PRESENTED WITH A STEMI. AN ATTEMPT WAS MADE TO USE THREE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SIGNIFICANTLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 100% STENOSIS LOCATED IN THE 1ST DIAGONAL BRANCH. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT IS INDICATED THAT AFTER PRE-DILATION THERE WAS 50% STENOSIS REMAINING. THE DEVICES DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. IT IS STATED THAT A SIGNIFICANT AMOUNT OF FORCE WAS USED DURING ATTEMPT TO DELIVER. IT IS STATED THAT A SUPPORTIVE GUIDEWIRE AND ALSO A GUIDELINER WERE USED IN THE ATTEMPT TO CROSS THE LESION. IT WAS REPORTED THAT ALL THREE STENTS WERE ATTEMPTED TO BE USED BUT ALL FAILED TO CROSS THE LESION. UPON REMOVAL OF THE 2.0X22MM AND 2.0X12MM STENTS, STENT DEFORMATION WAS OBSERVED. IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE 2.0X8MM STENT FOLLOWING FAILED DELIVERY THAT IT DISLODGED INSIDE THE GUIDE LINER CATHETER. IT IS INDICATED THAT THE STENT WAS NEVER LOST IN THE PATIENT, IT WAS OFF OF THE STENT DELIVERY SYSTEM AFTER WITHDRAWAL FROM THE BODY. NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8251921 ↗
• MalfunctionJan 8, 2019Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL (OM). BOTH DEVICES WERE INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT WHILE ATTEMPTING TO USE THE 2.00X22MM RESOLUTE ONYX STENT, THERE WERE INFLATION DIFFICULTIES AND THAT THE DEVICE WAS UNABLE TO CROSS THE LESION AND STENT DEFORMATION OCCURRED WITH STRUTS OF THE STENT PROTRUDING FROM THE BALLOON CATHETER. IT WAS ALSO REPORTED THAT THE 2.25X15 MM RESOLUTE ONYX STENT COULD NOT CROSS THE LESION AND STENT DEFORMATION OCCURRED WITH STRUTS OF THE STENT PROTRUDING FROM THE BALLOON CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227009 ↗
• InjurySep 21, 2018Device 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 MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE RAMUS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS ON NEUTRAL PRESSURE DURING DELIVERY. RESISTANCE WAS FELT WHILE TRYING TO GET THE STENT TO THE LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT GOT CAUGHT ON THE CALCIUM. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE, FROM THE PROFUNDA. NO PATIENT INJURY WAS REPORTED. IT IS NOTED THAT THE STENT DISLODGEMENT WAS DUE TO THE LESION AND NOT THE DEVICE ITSELF.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7896944 ↗
• MalfunctionAug 23, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE MID RAMUS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PASS THE DEVICE DISTAL TO A PREVIOUSLY DEPLOYED STENT AND STENT DEFORMATION OCCURRED IN VIVO. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809071 ↗