Resolute Onyx™ RONYX20012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00643169556638), received between Aug 24, 2018 and Sep 3, 2024 — classified as 3 deaths, 19 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (31 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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL CIRCUMFLEX (CX) ARTERY AND OBTUSE MARGINAL (OM). BOTH DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED ON THE RESOLUTE ONYX DEVICE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES ON THE ONYX FRONTIER DEVICE. 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 OF THE DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. AN ATTEMPT WAS FIRST MADE TO PLACE THE RESOLUTE ONYX STENT INTO THE DISTAL OM, AFTER PRE-DILATION, USING A NON-MEDTRONIC GUIDE EXTENSION CATHETER FOR ADDITIONAL SUPPORT. THE CX WAS HEAVILY CALCIFIED AND PREVENTED DELIVERY OF THE STENT TO THE OM. THE RESOLUTE ONYX STENT DISLODGED AND WAS REMOVED FROM THE PATIENT BY INFLATING A 1. 25X6MM SPRINTER BALLOON INTO THE LUMEN OF THE STENT AND PULLING THE STENT BACK INTO THE GUIDE, SUCCESSFULLY REMOVING IT FROM THE BODY. AN ATTEMPT

  Patient problems: Insufficient Information

  MAUDE report 20123675 ↗
• MalfunctionMar 27, 2024Entrapment of Device; Device Dislodged or Dislocated; Positioning Problem; Entrapment of Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. 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 THE DEVICE FAILED TO CROSS THE LESION. WHEN THE STENT WAS PULLED BACK THROUGH THE CATHETER, THE STENT UNKNOWINGLY CAME OFF THE BALLOON. THEN, WHEN AN ATTEMPT WAS MADE TO GO UP THE CATHETER WITH A NEW DIFFERENT STENT, THIS STENT ENDED UP TANGLING WITH THE DISLODGED RESOLUTE ONYX STENT LEFT IN THE CATHETER. THE ISSUE WAS SPOTTED PRIOR TO DEPLOYMENT AND BOTH STENTS WERE REMOVED SAFELY FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986043 ↗
• MalfunctionJun 22, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID OBTUSE MARGINAL (OM). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. 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 A STENT DISLODGEMENT OCCURRED DURING INSERTION INTO THE HOMEOSTATIC VALVE. IT WAS DETAILED THAT AN INITIAL ATTEMPT WAS MADE TO DELIVER THE STENT TO THE OM THROUGH A MID CIRCUMFLEX (CX) LESION. THE STENT WAS REMOVED INTACT. THE MID-CX LESION WAS THEN STENTED. UPON REINSERTION OF THE RESOLUTE ONYX STENT IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. USING FLUOROSCOPY, THE STENT WAS FOUND TO BE LODGED IN THE HOMEOSTATIC VALVE. THE HOMEOSTATIC VALVE WAS REMOVED AND REPLACED. A NEW 2.0X12MM RESOLUTE ONYX DES WAS INSERTED AND DEPLOYED WITH NO COMPLICATIONS AND NO ISSUES. THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180263 ↗
• InjuryMay 9, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID CIRCUMFLEX (CX) 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO STENT THE MID CX HOWEVER THE STENT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT DISLODGED IN THE LEFT MAIN (LM). IT WAS DETAILED THAT A RETRIEVAL WAS ATTEMPTED BUT FAILED. THE DISLODGED STENT WAS NOT REMOVED . A 4.0X12MM NON-MEDTRONIC DEVICE WAS USED TO CRUSHED THE DISLODGED STENT IN THE LM. THE CRUSHING TECHNIQUE CAUSED A 90% OSTIAL LESION OF THE LEFT ANTERIOR DESCENDING (LAD). THE PATIENT UNDERWENT BYPASS SURGERY FOR THE OSTIAL LAD AND MID 90% CIRCUMFLEX LESIONS. IT WAS STATED THAT THE PATIENT REQUIRED OPEN HEART SURGERY DUE TO DISLODGED STENT AND WAS RECOVERING IN INTENSIVE CARE UNIT (I

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

  MAUDE report 16893619 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE IMPLANTED. IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED AFTER THE STENT PROCEDURES AND THE PATIENT EXPERIENCED AN ITCHY RASH ALL OVER. THE PATIENT HAS BEEN TO AN ALLERGIST FOR TESTING AND HAD MEDICATIONS STOPPED, HOWEVER THE PATIENT STILL HAS THE RASH. STEROIDS WERE ALSO PRESCRIBED WHICH HELPED FOR A SHORT PERIOD OF TIME, HOWEVER THE RASH AND ITCHING HAS NOT GONE AWAY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Local Reaction

  MAUDE report 15585529 ↗
• InjuryOct 6, 2022Device 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING INSERTION INTO THE HOMEOSTATIC VALVE. IT WAS ALSO REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT DISLODGED BEFORE IT COULD GET DOWN TO THE VESSEL. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 15549137 ↗
• InjuryAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION WITH NO SIGNIFICANT TORTUOSITY ALTHOUGH ANGULATION WAS PRESENT AT THE ORIGIN OF THE OBTUSE MARGINAL (OM) RELATIVE TO THE CIRCUMFLEX. THE LESION HAD 80% STENOSIS. THERE WERE NO ISSUES NOTED DURING REMOVAL OF THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. MILD RESISTANCE WAS ENCOUNTERED, THIS WAS PRESUMED TO BE DUE THE ANGULATION OF THE VESSEL AND THE STENOSIS PRESENT. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO OR AT THE LESION. IT WAS DETAILED THAT THE DEVICE WAS IN POSITION IN THE PROXIMAL OBTUSE MARGINAL (OM). IT WAS NOT POSSIBLE TO DELIVER A BALLOON INTO THE DISTAL CIRCUMFLEX (FOR PROTECTION) THROUGH THE NON MEDTRONIC GUIDE EXTENSION CATHETER SUCH THAT IT WAS WITHDRAWN. IT WAS PLANNED TO REMOVE THE RESOLUTE ONYX 2.0MM STENT AND SUBSEQUENTLY THE NON MEDTRONIC GUIDE EXTENSION CATHETER, AND REPLACE BOTH THE STENT AND THE BALLOON. ON SLOW WITHDRAWS OF THE DEVI

  Patient problems: Insufficient Information

  MAUDE report 15202738 ↗
• InjuryAug 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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. A 1.5MM BALLOON WAS USED TO RETRIEVE THE DISLODGED STENT INTO THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15144336 ↗
• 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051899 ↗
• MalfunctionMay 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE STENT WAS INSERTED INTO THE DIAGONAL ARTERY AND THE STENT BALLOON WAS INFLATED. IT WAS REPORTED THAT WHEN THE BALLOON WAS DEFLATED THE STENT WAS NOT VISIBLE ON X-RAY. THE STENT WAS FOUND TO HAVE REMAINED ON THE STYLETTE AND WAS FOUND ON THE STERILE FIELD. IT WAS STATED THAT NOTHING WAS LEFT IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14494819 ↗
• MalfunctionMay 20, 2022Material 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14448246 ↗
• InjuryApr 20, 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 LESION IN THE DISTAL OF THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY AT THE LESION. THE STENT WAS CRUSHED, A SECOND MDT-STENT WAS PLACED TO COVER THE DISLODGED STENT. STENT EMBOLIZATION WAS REPORTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Embolism/Embolus; Insufficient Information

  MAUDE report 14160271 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG STENT WAS ATTEMPTED TO BE USED TO TREAT A LESION IN THE CIRCUMFLEX (CX). IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13276810 ↗
• MalfunctionDec 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12999006 ↗
• InjuryDec 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESIONS IN THE OSTIUM DIAGONAL BRANCH WITH 90% STENOSIS AND IN THE MID LAD WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 STENT DISLODGEMENT OCCURRED DURING DELIVERY. THE STENT CAME OFF THE BALLOON AFTER LEAVING THE GUIDE INTO THE LAD. ATTEMPTS WERE MADE TO REMOVE THE DISLODGED STENT BUT THEY WERE UNSUCCESSFUL. THE BALLOON WAS MOVED DOWN THE GUIDEWIRE INTO THE 1ST DIAGONAL AND THEN PUSHED INTO THE STENT. THE STENT WAS DEPLOYED INTO THE OSTIUM OF THE DIAGONAL WITH THE PROXIMAL PORTION OF THE STENT LEFT IN THE LAD. AFTER, ANOTHER STENT WAS THEN PLACED OVER THE PROXIMAL EDGE OF THE STENT INTO ANOTHER LESION IN THE LAD AND BOTH THE LESION AND STENT WERE CRUSHED INTO THE WALL OF THE LAD STENT. IT WAS SUGGESTED THAT THE STENT APPEARED TO COME OFF THE BALLOON WHILE EXITING THE GUIDE. THERE WERE TWO WIRES I

  Patient problems: Insufficient Information

  MAUDE report 12983006 ↗
• MalfunctionNov 3, 2021Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING DELIVERY. THE DEVICE WAS NOT REMOVED FROM PATIENT. THE STENT WAS DEPLOYED BUT NOT IN THE INTENDED AREA OF THE VESSEL BY INFLATING THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12744949 ↗
• InjuryAug 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE PROXIMAL/ MID LAD ARTERY WITH 90% STENOSIS. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE 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 DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT TWO STENTS FAILED TO CROSS THE LESION. THE RESOLUTE ONYX WAS THEN ATTEMPTED TO CROSS THE LESION, HOWEVER THE STENT DISLODGED ON CALCIFICATION DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS NOT REMOVED AND THE PATIENT WAS SENT FOR CABG. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12292588 ↗
• MalfunctionApr 21, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A LESION IN THE LAD. THERE WAS NO DAMAGED NOTED TO THE OUTER PACKAGING. 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 DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT BROKE. IT WAS STATED THAT THE STRUT LIFTED WHILE DELIVERING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700523 ↗
• InjuryApr 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH MULTIPLE BALLOONS. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT THE STENT GOT STUCK IN THE FIRST STENT AND WAS WEDGED. THE STENT WAS THEN DEPLOYED WITH A SMALLER 1.25MM BALLOON AND WORKED UP TO A 2.5X12MM BALLOON. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11626020 ↗
• MalfunctionMar 24, 2021Fracture; Fracture

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND A STENT FRACTURE OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561616 ↗
• MalfunctionFeb 11, 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL / OSTIUM OF THE CIRCUMFLEX (CX) 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 PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. THE STENT WAS NOT REMOVED AND IT WAS DEPLOYED IN THE PROXIMAL AREA. IT WAS BELIEVED THAT THE STENT GOT HUNG UP ON THE EXISTING OSTIAL STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11312628 ↗
• InjuryFeb 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE DISTAL CIRCUMFLEX. NEGATIVE PREP WAS PERFORMED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS STATED THAT THE STENT WAS CRUSHED AS AN INTERVENTION. THE PATIENT IS ALIVE AND NO INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11257352 ↗
• MalfunctionJan 29, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND SEVERELY TORTUOUS LESION EXHIBITING 85% STENOSIS LOCATED BETWEEN THE PROXIMAL TO DISTAL RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. IT WAS REPORTED THAT THE CATHETER DETACHED/FRACTURED DURING ADVANCEMENT THROUGH GUIDE CATHETER. THE DEVICE WAS KINKED AND RESTRAIGHTENED DURING USE. IT WAS STATED THAT ALL COMPONENTS OF STENT WERE REMOVED SUCCESSFULLY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250458 ↗
• MalfunctionDec 11, 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A 1.5X10 MM SPRINTER BALLOON. 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 REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS REMOVED FROM THE PATIENTS BODY. UPON EXAMINATION THE STENT WAS NO LONGER SECURE ON THE DELIVERY SYSTEM AND HAD DISLODGED ONTO A TOWEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10994293 ↗
• InjuryDec 3, 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 MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10940504 ↗