Resolute Onyx™ RONYX20030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169556683), received between Jun 6, 2018 and May 30, 2025 — classified as 2 deaths, 18 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (21 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A COMPLEX PERCUTANEOUS CORONARY INTERVENTION, ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT FAILED TO CR OSS THE LESION. THE LESION WAS CALCIFIED AND IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS USED TO ADVANCE THE STENT TO THE LESION. THE STENT FAILED TO CROSS THE LESION AND WHEN PULLING THE STENT BACK INTO THE GEC, THE STENT CAME OFF THE DELIVERY CATHETER/BALLOON. THE STENT WAS SUBSEQUENTLY JAILED USING ANOTHER STENT. THE PATIENT IS DOING WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22113909 ↗
• MalfunctionFeb 17, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE DISTAL 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 STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH A SAME SIZE RESOLUTE ONYX STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395293 ↗
• MalfunctionNov 10, 2022Material Deformation; Material Deformation

  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 70% STENOSIS LOCATED IN THE DISTAL 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15769496 ↗
• InjuryJun 27, 2022Defective Component; Device Dislodged or Dislocated; Defective Component; 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 95% STENOSIS IN THE OSTIAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. IT WAS ALSO REPORTED THAT WHEN THE OPERATOR DEPLOYED THE STENT IT WAS NOTED TO HAVE FORESHORTENED CONSIDERABLY. THE PATIENT WAS SENT FOR SURGERY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 14827569 ↗
• InjuryMay 20, 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL OBTUSE MARGINAL (OM). 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO DURING DELIVERY TO/AT A LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14452802 ↗
• 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 SMALL, TIGHT STENOSIS AND CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A STENT STRUT WAS RAISED AFTER THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. IT WAS STATED THAT THIS WAS BECAUSE OF THE LESION CHARACTERISTICS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14448302 ↗
• InjuryFeb 8, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS PULLED BACK TO THE RIGHT FEMORAL AND REMOVED USING ANOTHER BALLOON. ANOTHER STENT WAS THEN DEPLOYED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13478884 ↗
• MalfunctionDec 2, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A ACC/AHA TYPE C HIGH RISK LESION WITH 99% STENOSIS, LOCATED IN THE PROXIMAL OM BRANCH. THE DEVICES WERE INSPECTED BEFORE USE, WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 2.0 X 15 MM NON-MEDTRONIC NC BALLOON. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICES TO THE LESION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE 2.0 X 30 MM STENT WAS UNABLE TO CROSS THE LESION. ON REMOVAL IT WAS NOTED THAT THE STRUTS WERE ALL SEVERELY DAMAGED. A 2.0 X 15 MM NON-MEDTRONIC NC BALLOON WAS THEN USED TO FURTHER PRE-DILATE THE LESION. THE SECOND 2.0 X 26 MM STENT WAS THEN ATTEMPTED TO BE USED, BUT ALSO DID NOT CROSS THE LESION. NO DEFORMATION WAS NOTED TO THIS STENT UPON REMOVAL. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915284 ↗
• 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 12133353 ↗
• MalfunctionFeb 8, 2021Device 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 LESION LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS NOT REMOVED AND LEFT IN THE LEFT MAIN ARTERY. IT WAS STATED THAT THE PHYSICIAN BELIEVED THAT THE STENT WAS POSSIBLY STRIPPED OFF BY THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY IN ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 11292956 ↗
• MalfunctionFeb 4, 2021Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENTS FAILED TO CROSS THE LESION AND STENT STRUTS WERE NOTED TO BE LIFTED/FRACTURED ON REMOVAL. THE PROCEDURE WAS COMPLETED USING A SHORTER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278958 ↗
• MalfunctionFeb 4, 2021Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENTS FAILED TO CROSS THE LESION AND STENT STRUTS WERE NOTED TO BE LIFTED/FRACTURED ON REMOVAL. THE PROCEDURE WAS COMPLETED USING A SHORTER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278917 ↗
• InjuryNov 11, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DES (2.50X38MM AND 2.00X30MM) TO TREAT MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE PROXIMAL AND DISTAL CX ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. RESOLUTE ONYX 2.50X38MM DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND 2.00X30MM DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE ONYX 2.50X38MM WAS PLACED AT THE PROXIMAL CRX WITH NO ISSUE. THE ONYX 2.00X30MM WAS TO BE PLACED IN THE DISTAL CRX, BUT WAS UNSUCCESSFUL DUE TO CALCIFICATION AND FAILED TO CROSS THE LESION. UPON REMOVING THE ONYX 2.00X30MM IT GOT CAUGHT ON THE ONYX 2.50X38MM AND DISLODGED. STENT DISLODGEMENT WAS NOT REALISED UNTIL THE DEVICE WAS REMOVED FROM THE PATIENT AND INSPECTED, THE STENT WAS NOTED TO BE MISSING. A NON MEDTRONIC SNARE WAS USED AND BOTH STENTS WERE SUCCESSFULLY REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10821984 ↗
• InjuryNov 3, 2020Device 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 DES TO TREAT A LESION IN THE OBTUSE MARGINAL. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THAT THE STENT WAS HUNG UP ON THE GUIDE AT THE GUIDE TRANSITION POINT UPON WITHDRAWAL. IT WAS INDICATED THAT THE STENT MAY HAVE INCURRED SOME STRUT DAMAGE DURING DELIVERY ATTEMPT AND THAT STRUT DAMAGE CONTRIBUTED TO THE HANG UP ON THE GUIDE. INFLATION OF THE DELIVERY SYSTEM BALLOON NEAR/WITHIN THE GUIDE WAS ATTEMPTED TO SECURE THE STENT BUT THIS WAS UNSUCCESSFUL. DURING THE PROCESS OF ATTEMPTING TO CAPTURE THE STENT WITH A SNARE, THE STENT MIGRATED DOWN THE AORTA, PAST THE COMMON FEMORAL AND ULTIMATELY BECAME LODGED IN THE PROFUNDA ARTERY. RETRIEVAL WITH A SNARE WAS UNSUCCESSFUL AFTER SEVERAL ATTEMPTS. THE STENT WAS NOT REMOVED FROM THE PATIENT. THE STENT WAS CRUSHED INTO THE SIDEWALL OF THE PROFUNDA ARTERY WITH A BALLOON DILATATION CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10776867 ↗
• InjuryOct 28, 2020Material Separation

  DURING A HEART CATHETERIZATION PROCEDURE A STENT WAS NOT ABLE TO MAKE IT TO THE DESIRED DESTINATION IN THE VEIN. WHEN RETRACTING THE INTRODUCER WITH THE STENT, THE STENT CAME OFF WITHOUT BALLOON INFLATION. THE SENT THEN HAD TO BE RETRIEVED FROM INSIDE THE PATIENT. THERE WERE NO RELEVANT TEST RESULTS TO REPORT. FLUOROSCOPY IS IN USE DURING THE PROCEDURE AND THE EVENT WAS IMMEDIATELY IDENTIFIED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10755709 ↗
• InjuryOct 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVER. THE STENT WAS REMOVED USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY, THE PATIENT WENT TO SURGERY FOR CABG.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10704773 ↗
• MalfunctionOct 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL LAD. 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 BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS STATED THAT THE DISLODGED STENT WAS REMOVED WITH THE GUIDE CATHETER. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10655788 ↗
• DeathAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE ONE RESOLUTE ONYX DES STENT WAS IMPLANTED IN THE DISTAL LAD. APPROXIMATELY 10 MONTHS LATER THE PATIENT SUFFERED APPENDICEAL SIGNET RING CELL ADENOCARCINOMA. THE PATIENT HAD A PROLONGED HOSPITAL VISIT AND WAS TREATED WITH ILEOCOLECTOMY APPENDECTOMY. APPROXIMATELY 18 MONTHS POST PROCEDURE THE PATIENT DIED. THE DEATH WAS CLASSIFIED AS A NON SUDDEN CARDIAC DEATH. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE MEDICATION OR THE DEVICE.

  Patient problems: Death

  MAUDE report 10458529 ↗
• 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 10127358 ↗
• MalfunctionFeb 17, 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 LOCATED IN THE MID CIRCUMFLEX (CX) 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 NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS STATED THE DISLODGED STENT WAS IN THE GUIDE CATHETER. THE GUIDE CATHETER WAS REMOVED FROM THE PATIENT AND THE DISLODGED STENT WAS THEN REMOVED FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING TWO SHORTER RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716675 ↗
• InjuryDec 20, 2019Adverse 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 9 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ACUTE ON CHRONIC BLOOD LOSS ANEMIA. IT WAS REPORTED THAT THE CAUSE OF BLEEDING WAS EXTERNAL HEMORRHOIDS. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. EVENT WAS TREATED WITH BLOOD TRANSFUSION. INVESTIGATOR AND SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 9502802 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE ONYX DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID DIAGONAL BRANCH. THE DEVICE WAS INSPECTED 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS STATED THAT THE STENT APPEARED TO BE IMPLANTED SUCCESSFULLY WITH NO DEFORMATION ISSUES OR KINKS NOTED. IT WAS REPORTED THAT THE PATIENT SUFFERED SUB-ACUTE STENT THROMBOSIS 8 DAYS POST STENT IMPLANT. THE PATIENT ALSO SUFFERED VESSEL OCCLUSION DUE TO THE THROMBUS. IT WAS STATED THAT THE THROMBOSIS WAS BELIEVED TO BE RELATED TO POSSIBLE DAPT COMPLIANCE ISSUES. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Occlusion; Thrombus

  MAUDE report 9443323 ↗
• MalfunctionNov 20, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) 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 NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A 2.0X18MM RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346839 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY MI. DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD. THE PATIENT HAD A NOSEBLEED AND WAS TREATED WITH NASAL CAUTERY AND RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI PLATELETS. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE ANTI PLATELETS. THE CEC ADJUDICATED A STROKE OCCURRED.

  Patient problems: Stroke/CVA

  MAUDE report 9201177 ↗
• MalfunctionSep 11, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION EXHIBITING 90% STENOSIS IN THE DISTAL 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 NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DAMAGE OCCURRED TO THE STENT AND THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION INSIDE THE GUIDE LINER. THE GUIDE LINER WAS REMOVED WITH THE DISLODGED STENT INSIDE IT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8991698 ↗