Resolute Onyx™ RONYX20018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169556652), received between Jun 20, 2018 and Sep 5, 2025 — classified as 14 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG-ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE LESION BEING TREATED WAS SEVERELY CALCIFIED LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975594 ↗
• MalfunctionJun 7, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION WITH 85% STENOSIS IN THE DISTAL RIGHT POSTERIOR DESCENDING (R-PDA) ARTERY. THERE WAS A PREVIOUSLY DEPLOYED STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT A BUDDY WIRE TECHNIQUE WAS BEING USED FOR THE PURPOSE OF STENT DELIVERY. ONCE THE STENT CAME OFF THE BALLOON DELIVERY SYSTEM A TECHNIQUE OF TWISTING THE TWO WIRES TOGETHER WAS USED, AND THIS CAPTURED THE LOOSE STENT, REMOVING IT FROM THE PATIENT. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482848 ↗
• InjuryJul 27, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, NON-CALCIFIED LESION IN THE OSTIUM RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 A FAILED DELIVERY. IT WAS DETAILED THAT FOLLOWING PRE-DILATION TO THE AFFECTED AREA THE STENT WAS ATTEMPTED TO BE ADVANCED TOWARDS THE LESION HOWEVER, THE STENT FAILED TO ADVANCE. THE STENT WAS THEN ATTEMPTED TO BE REMOVED HOWEVER, THE STENT DISLODGED IN THE LEFT MAIN (LM) ARTERY. IT IS UNKNOWN WHETHER THE STENT GOT CAUGHT ON THE STRUTS OF A PREVIOUSLY DEPLOYED STENT IN THE LEFT MAIN (LM), OR ON THE GUIDE CATHETER. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED TO THE VESSEL WALL WITH A 2.25X15MM NON-MEDTRONIC BALLOON AND THEN A 3.5X15MM NON-MEDTRONIC BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 17405816 ↗
• 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 15585523 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE STENT FROM THE BALLOON, THE STENT SHEARED OFF AND WAS LEFT INSIDE THE VESSEL. RETRIEVAL ATTEMPTS WERE UNSUCCESSFUL. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13868505 ↗
• InjuryMar 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE PHYSICIAN STATED THAT THEY THINK THE STENT HOOKED ON THE PREVIOUSLY DEPLOYED STENT AND DID NOT BLAME THE RESOLUTE ONYX STENT. THE DISLODGED STENT WAS REMOVED BY PASSING A SMALL BALLOON DISTAL TO THE STENT, INFLATING THE BALLOON MINIMALLY AND PULLING THE STENT BACK INTO THE GUIDE EXTENSION CATHETER AND THE GUIDE CATHETER. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13838380 ↗
• InjuryFeb 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION WITH 90% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) 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 DEVICE. EXCESSIVE FORCE WAS USED.   IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE STENT WAS UNABLE TO BE DELIVERED TO THE MID LAD, AND THE PATIENT WAS LEFT WITH A DISSECTION. THE DISLODGED STENT WAS SNARED FROM THE VESSEL DOWN INTO THE RADIAL ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT FROM THE RADIAL ARTERY, AND IT WAS POSSIBLE TO BRING THE STENT TO THE ARTERIAL ACCESS SITE. HOWEVER, THE STENT WAS NOT REMOVED. A VASCULAR SURGEON WAS CALLED FOR CONSULT. A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS REPORTED TO BE THE REASON FOR THE STENT DISLODGEMENT OCCURRING. NO CHEST PAIN OR EKG CHANGES WERE NOTED POST PROCEDURE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 13577381 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE FIRST STENT FAILED TO CROSS THE LESION ON MULTIPLE ATTEMPTS AND WHEN REMOVED FROM THE PATIENT A STENT STRUT WAS NOTED TO BE LIFTED. A SECOND STENT WAS THEN ATTEMPTED BUT ALSO FAILED TO CROSS THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13008468 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LAD. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THEN CAME OFF THE BALLOON. ANOTHER BALLOON WAS THEN USED AND THE STENT WAS DEPLOYED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12568356 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT SUFFERED OF CARDIAC ARREST AFTER BELOW-KNEE AMPUTATION. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED A MYOCARDIAL INFARCTION OCCURRED (UNKNOWN VESSEL) DUE TO TROPONIN INCREASE AFTER PROLONGED RESUSCITATION.

  Patient problems: Myocardial Infarction

  MAUDE report 11655017 ↗
• InjuryFeb 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 AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE STENT WAS INSPECTED WITH NO ISSUES NOTED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY FOLLOWING A FAILED DELIVERY. IT WAS BELIEVED THAT THE DISLODGEMENT OCCURRED DURING ONE OF THE MULTIPLE EXCHANGES MADE DURING THE PROCEDURE. THE STENT EITHER CAME LOOSE / DISLODGED BY CATCHING THE PROXIMAL EDGE OF THE STENT ON THE DISTAL TIP OF THE TELESCOPE DURING EXCHANGE OR A COMBINATION OF MULTIPLE ATTEMPTS TO ADVANCE THE STENT THROUGH THE SEVERE LESION CALCIFICATION AND THE EXCHANGES THROUGH THE TELESCOPE. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS NOT IDENTIFIED AS MISSING UNTIL ALL DEVICES HAD BEEN REMOVED AND PROCEDURE DEEMED COMPLETED. THE PATIENT WAS BROUGHT BACK LATER IN THE DAY AND RE-INTERVENED. DURING THE SECOND PROCEDURE, A WIRE WAS PASSED DISTAL TO THE DISLODGED STENT AND ANOTHER

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11313698 ↗
• InjuryOct 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A 2.0 X 18 MM RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID-DISTAL 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. PRIOR TO ATTEMPTING THE 2.0 X 18 MM DEVICE, A 2.75 MM RESOLUTE ONYX WAS DEPLOYED IN THE PROXIMAL VESSEL AND ANOTHER 2.75 MM RESOLUTE ONYX WAS DEPLOYED DISTAL. IT WAS STATED THAT THESE STENTS WERE POST-DILATED AND NOT UNDER-DEPLOYED IN ANY MANNER. A THIRD 2.75 MM RESOLUTE ONYX WAS ALSO ATTEMPTED BUT FAILED TO CROSS. THE LESION WAS BALLOONED AGAIN. IT WAS REPORTED THAT THE 2.0 X18 MM STENT DISLODGED DURING DELIVERY TO THE LESION. AN ATTEMPT WAS MADE TO REMOVE THE STENT BUT WAS U NSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DISLODGED STENT AND TO TREAT THE MID-DISTAL LESION. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10689183 ↗
• MalfunctionOct 13, 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

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

  MAUDE report 10668957 ↗
• MalfunctionAug 13, 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 EXHIBITING 99% STENOSIS LOCATED IN THE MID OBTUSE MARGINAL (OM). 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS STATED THAT THE STENT WAS DEPLOYED WITH NO PROBLEMS WHERE IT DISLODGED, WHICH WAS IN THE LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10401287 ↗
• MalfunctionJul 13, 2020Device 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 MODERATELY TORTUOUS AND CALCIFIED LESION IN THE DISTAL LAD WITH 75% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT 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 AFTER REMOVAL FROM THE PATIENT. AFTER A FAILED DELIVERY, THE STENT DISLODGED FROM THE BALLOON AT THE TOUHY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263345 ↗
• InjuryJul 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE DISLODGED STENT WAS REMOVED USING A SNARE. IT WAS STATED THAT TWO OPERATORS (4TH YEAR FELLOWS AND 2ND DAY OPERATORS), UNDER THE SUPERVISION OF THE ATTENDING PHYSICIAN, IMPLANTED A LONG NON-MEDTRONIC STENT TO THE PROXIMAL/MID LAD OVERLAPPING PREVIOUS IMPLANTED STENTS PLACED IN THE SAME ANATOMY IN A PREVIOUS PROCEDURE. THIS NON-MEDTRONIC STENT WAS PLACED BECAUSE THE PATIENT WAS SUFFERING FROM IN-STENT RESTENOSIS. AFTER IMPLANTATION OF THIS NON-MEDTRONIC STENT, AN OCCLUSION OCCURRED IN THE DISTAL LAD. AN ATTEMPT WAS THEN MADE TO IMPLANT A RESOLUTE ONYX 2.0 X 12MM STENT INTO THE DISTAL LAD TO FIX THE DISTAL OCCLUSION OF THE LAD. AFTER INSERTION OF THE STENT DISTAL TO THE NON-MEDTRONIC STENT IN THE LAD, IT WAS DECIDED TO PULL THE STENT OUT AND UTILIZE A LONGER STENT, A R

  Patient problems: Injury; Insufficient Information

  MAUDE report 10223133 ↗
• MalfunctionApr 8, 2020Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE, ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A LESION. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE RESOLUTE ONYX STENT WAS 12 DAYS PAST ITS EXPIRATION DATE WHEN IMPLANTED. IT WAS STATED THAT THIS ISSUE WAS DISCOVERED AFTER THE STENT WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9937155 ↗
• InjuryMar 9, 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO DURING POSITIONING. IT WAS STATED THAT THE STENT PRE-MATURELY CAME OFF THE DELIVERY CATHETER INSIDE THE PATIENTS RIGHT CORONARY ARTERY (RCA). IT APPEARED THE STENT WAS STRIPPED OFF THE BALLOON CATHETER WHILE ATTEMPTING TO CROSS THROUGH EXISTING STENT STRUTS. THE DELIVERY CATHETER WAS REMOVED. A BALLOON CATHETER WAS USED TO CRUSH THE DISLODGED STENT AGAINST THE VESSEL WALL AND THE STENT WAS THEN COVERED WITH A NEW STENT. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Injury

  MAUDE report 9805239 ↗
• MalfunctionMar 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 SEVERELY CALCIFIED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT WHEN ATTEMPTING TO CROSS TWO STENTS IN THE MID RCA, THE THIRD STENT WAS DISLODGED. THE STENT WAS DISLODGED IN THE PROXIMAL AREA OF VESSEL. USING A BALLOON, THE STENT WAS DEPLOYED AND EXPANDED IN THE PROXIMAL REGION OF THE RCA. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779233 ↗
• MalfunctionJan 13, 2020Device 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, MODERATELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580085 ↗
• InjuryJan 8, 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 1ST OBTUSE MARGINAL. APPROXIMATELY 5 MONTHS POST PROCEDURE, PATIENT SUFFERED WORSENING OF END STAGE RENAL DISEASE WHICH WAS TREATED WITH PERITONEAL DIALYSIS. PATIENT RECOVERED. CEC ADJUDICATED NON-Q-WAVE MI OF UNKNOWN VESSEL. INVESTIGATOR AND SAFETY ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9563419 ↗
• InjuryJan 8, 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 1ST OBTUSE MARGINAL. APPROXIMATELY 5 MONTHS POST PROCEDURE, PATIENT SUFFERED END STAGE RENAL DISEASE WHICH WAS TREATED WITH BLOOD TRANSFUSION, PERITONEAL DIALYSIS AND MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED A NON Q WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9563244 ↗
• MalfunctionNov 27, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) 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 DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A 2.0 MM RESOLUTE ONYX. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382419 ↗
• MalfunctionAug 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DES TO TREAT A LESION IN THE OSTIAL RCA. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND FELL OFF BALLOON BEFORE DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854142 ↗
• MalfunctionApr 9, 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, MODERATE CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS REPORTED THAT THE STENT NEVER MADE IT TO THE CORONARY ARTERY. IT WAS REPORTED THAT THE CALCIFICATION AT SUBCLAVIAN AND A BALLOON IN THE GUIDE CAUSED THE DISLODGEMENT. DISLODGED STENT WAS REMOVED WHEN REMOVING THE GUIDE CATHETER. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED IN THE GUIDE. IT WAS REPORTED THAT THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8494581 ↗