Resolute Onyx™ RONYX22522UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169556737), received between Sep 1, 2017 and Jul 1, 2022 — classified as 2 deaths, 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT BOTH STENTS CAME OFF THEIR BALLOONS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883062 ↗
• MalfunctionJul 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE ATTEMPTED TO BE USED TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT BOTH STENTS CAME OFF THEIR BALLOONS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14883051 ↗
• MalfunctionApr 25, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING TO TREAT A CALCIFIED LESION IN THE MID CIRCUMFLEX ARTERY (CX). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DAMAGE OCCURRED DURING WITHDRAWAL OF THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191680 ↗
• MalfunctionJan 25, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT AN EXPIRED RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED IN A PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221824 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED: THREE IN THE LAD AND ONE IN THE 1ST DIAGONAL. APPROXIMATELY 10 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO BILATERAL PNEUMONIA AND ONGOING SEPSIS. THE EVENT WAS TREATED WITH MEDICATION BUT THE PATIENT DIED APPROXIMATELY 5 DAYS LATER. ACUTE RESPIRATORY DISTRESS SYNDROME WAS THE PRIMARY CAUSE OF DEATH AND WAS ASSESSED AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION BY THE INVESTIGATOR AND SPONSOR. THE DEATH WAS CLASSIFIED AS A NON-CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE SEPSIS AS NOT RELATED TO STUDY DEVICE OR ANTI PLATELET MEDICATION AND THE SPONSOR ASSESSED IT AS UNLIKELY RELATED TO STUDY DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Pneumonia

  MAUDE report 10990352 ↗
• InjuryDec 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 MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING CHRONIC TOTAL OCCLUSION (CTO) LOCATED 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 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 DELIVERY TO/AT A LESION. IT WAS STATED THAT THE STENT WAS NOT REMOVED FROM THE PATIENT. A BALLOON WAS USED TO CRUSH THE DISLODGED STENT INTO THE LAD PROXIMAL TO THE TARGET LESION. ANOTHER 2.5 X 22MM ONYX STENT WAS USED TO STENT OVER THE DISLODGED STENT, TRAPPING IT BEHIND THE DEPLOYED STENT. IT WAS STATED THAT THE STENT THAT THE 2.25 X 22 ONYX WAS ATTEMPTING TO CROSS WAS SEVERELY UNDER DEPLOYED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10975015 ↗
• InjuryOct 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX DES WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS IN THE 1ST OBTUSE MARGINAL. THE PROXIMAL CX AND THE DISTAL LEFT MAIN WERE ALSO STENTED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO DAMAGE NOTED WHEN REMOVING THE 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. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION AND FLOW WAS LOST IN THE LAD. THE DISLODGED STENT WAS CRUSHED IN THE LAD, IN ORDER TO SAVE THE LAD. IT WAS ALSO REPORTED THAT MI AND VESSEL OCCLUSION OCCURRED DUE TO THE DEVICE. A 2.75 X 18 MM STENT WAS THEN IMPLANTED IN THE PROXIMAL LAD AND A 3.0 X 8 MM STENT IN THE LEFT MAIN/OSTIAL LAD. PATIENT WAS SENT TO ANOTHER HOSPITAL ((B)(6) HOSPITAL) AND REQUIRED BYPASS SURGERY TWO DAYS LATER. THE PATIENT IS REPORTED TO BE ALIVE WITH INJURY.

  Patient problems: Injury; Insufficient Information; Myocardial Infarction; Obstruction/Occlusion; Occlusion

  MAUDE report 10711157 ↗
• DeathAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX RX STENTS WERE IMPLANTED BETWEEN THE DISTAL LAD WHICH HAD A CHRONIC TOTAL OCCLUSION AND THE PROX LAD WHICH HAD NO OCCLUSION. APPROXIMATELY 32 MONTHS LATER THE PATIENT SUFFERED CARDIOGENIC SHOCK AND CHEST PAIN. THE PATIENT WAS TREATED WITH MEDICATION. WITHIN 24 HOURS THE PATIENT PRESENTED TO ER WITH W/C/O CP & SOB; BRADYCARDIC FOLLOWED BY CARDIAC ARREST. THE PATIENT DIED DUE TO CARDIOGENIC SHOCK. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO INDEX DEVICE AND ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Cardiogenic Shock; Death; Myocardial Infarction

  MAUDE report 10447106 ↗
• InjuryJun 25, 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 MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL/MID OBTUSE MARGINAL (OM) / 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED AND A 2.0X20MM EUPHORA BALLOON WAS INSERTED OVER THE WIRE AND INSIDE THE DISLODGED STENT, THE BALLOON WAS INFLATED DEPLOYING THE STENT INSIDE THE CIRCUMFLEX ARTERY. A 2.25X15MM NC EUPHORA WAS THEN USED TO DILATE THE STENT TO THE RIGHT SIZE OF THE VESSEL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 10193882 ↗
• InjuryMay 15, 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 AND MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVER TO THE LESION. IT WAS STATED THAT A FRESHLY IMPLANTED STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY CAUGHT ON THE RESOLUTE ONYX STENT AS IT WAS ATTEMPTED TO BE DELIVERED TO THE OSTIUM. THE DISLODGED STENT WAS REMOVED USING A SNARE FROM THE PROXIMAL / OSTIAL LEFT MAIN. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; Vascular Dissection

  MAUDE report 10060670 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY LESION EXHIBITING 99% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLETTE FROM THE DEVICE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. THE LESION WAS PREPPED WITH ROTABLATION. AN ATTEMPT WAS MADE TO ADVANCE AND INFLATE THE SPRINTER LEGEND DEVICE. IT WAS REPORTED THAT ON THE FIRST INFLATION/DEFLATION THE BALLOON WAS SLOW TO DEFLATE. CONTRAST WAS PERCEIVED TO BE IN THE BALLOON. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. ON THE SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE, WITH THE INDEFLATOR AND EMPTY SY

  Patient problems: Intimal Dissection; Myocardial Infarction

  MAUDE report 9861251 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE SPRINTER LEGEND RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY LESION EXHIBITING 99% STENOSIS. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH / PACKAGING STYLETTE FROM THE DEVICE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT NOTED WHILE ADVANCING THE DEVICE TO THE LESION. THE LESION WAS PREPPED WITH ROTABLATION. AN ATTEMPT WAS MADE TO ADVANCE AND INFLATE THE SPRINTER LEGEND DEVICE. IT WAS REPORTED THAT ON THE FIRST INFLATION/DEFLATION THE BALLOON WAS SLOW TO DEFLATE. CONTRAST WAS PERCEIVED TO BE IN THE BALLOON. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. ON THE SECOND INFLATION THE BALLOON WOULD NOT DEFLATE. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE, WITH THE INDEFLATOR AND EMPTY SY

  Patient problems: Intimal Dissection; Myocardial Infarction

  MAUDE report 9861166 ↗
• InjuryMar 16, 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 (RONYX22538UX) WAS IMPLANTED IN THE LAD. ONE RESOLUTE ONYX DRUG ELUTING STENT (RONYX22522UX) WAS IMPLANTED IN THE CX DURING A PLANNED STAGED PROCEDURE. ON THE SAME DAY AS THE STAGED PROCEDURE THE PATIENT SUFFERED IN-STENT CORONARY ARTERY RESTENOSIS TREATED WITH REVASCULARIZATION OF THE LAD (CASS 13). THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE DEVICE. CEC ADJUDICATED THE REVASCULARIZATION AS NO EVENT AND COMMENTED "NO CHANGE. STAGED PROCEDURE WITH PLAQUE SHIFT FROM OSTIAL LCX AND DISTAL LEFT MAIN TO OSTIAL LAD PROMPTING RESCUE OF LAD." SAFETY COMMENTED ISR.

  Patient problems: Occlusion

  MAUDE report 9835776 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE A PATIENT WAS IMPLANTED WITH A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION LOCATED IN THE OSTIUM OF THE DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT THROMBOSIS (0-24 HOURS POST STENT IMPLANTATION) AND A MYOCARDIAL INFARCTION (12 HOURS POST STENT IMPLANTATION) RELATED TO THE TARGET VESSEL OCCURRED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 9545771 ↗
• InjurySep 12, 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 MODERATELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID-DISTAL CIRCUMFLEX (CX) 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED BY USING A BALLOON AND TRAPPING IT AGAINST THE NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9005922 ↗
• MalfunctionAug 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY. THE LESION WAS PRE DILATED AGAIN WITH A 2.0 X 20MM BALLOON AND THEN WAS RE STENTED. THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8892064 ↗
• MalfunctionJun 17, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE FIRST DIAGONAL. THE LESION WAS PREDILATED. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND THAT A STRUT WAS NOTED TO BE LIFTED. THE PROCEDURE WAS COMPLETED USING A NON MEDTRONIC DEVICE. THE PATIENT IS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704031 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 3 RESOLUTE ONYX DES WERE IMPLANTED I THE 1ST OBTUSE MARGINAL, 2ND OBTUSE MARGINAL AND RCA. IT WAS REPORTED THE SAME DAY POST PROCEDURE THERE WAS NO REFLOW WHICH WAS TREATED WITH MEDICATION. PATIENT IS RECOVERED. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR INDEX DEVICE. SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION BUT POSSIBLY RELATED TO THE INDEX DEVICE .

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8420728 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL, ONE RESOLUTE ONYX WAS IMPLANTED IN THE 2ND OBTUSE MARGINAL AND ONE RESOLUTE ONYX WAS IMPLANTED IN THE RCA. POST PROCEDURE PATIENT SUFFERED PCI RELATED MI.

  Patient problems: Myocardial Infarction

  MAUDE report 8398279 ↗
• InjuryFeb 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (2.25 X 22MM) TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE DISTAL RCA. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. THERE WAS A PROXIMAL LESION IN THE RCA AS WELL AS A MID TO DISTAL LESION IN THE RCA. THE PROXIMAL LESION WAS PRE-DILATED AND STENTED USING 3.0 X 22MM RESOLUTE ONYX, AND POST-DILATED WITH AN 3.5 NC EUPHORA BALLOON. THE DISTAL LESION WAS THEN PRE-DILATED WITH A 2.0 EUPHORA BALLOON AND THE 2.25 X 22MM STENT WAS ADVANCED THROUGH THE PROXIMAL RCA/STENT TO THE MID-DISTAL PART OF THE RCA. THE STENT COULD NOT BE ADVANCED FAR ENOUGH DOWN THE VESSEL FOR PLACEMENT, AND AN ATTEMPT WAS MADE TO PULL BACK THE STENT TO FURTHER PRE-DILATE THE DISTAL LESION BEFORE PLACING THE STENT. WHEN THE STENT WAS PULLED BACK, THE STENT BECAME DISLODGED FROM THE BALLOON WHEN IT GOT CAUGHT ON THE DISTAL EDGE OF THE PROXIMAL 3.0 X 22 STENT. A NON MEDTRONIC BALLOON WAS USED AND WAS ABLE TO CAR

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8334610 ↗
• MalfunctionJan 18, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE MID RCA WITH 98% STENOSIS. THE DEVICE WAS NOT INSPECTED. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX 2.25 X 26 MM STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8260070 ↗
• InjuryJul 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A NON-TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE O STIUM-PROXIMAL CIRCUMFLEX ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS PASSED TO THE LESION MULTIPLE TIMES POST LESION PREP AND DILATION. POSITIONING AND CROSSING THE LESION WAS DIFFICULT DUE TO CALCIFICATION. IT WAS REPORTED THAT DURING THE FINAL ATTEMPT TO PASS THE STENT TO THE LESION, THE STENT DISLODGED.THE DELIVERY SYSTEM WAS REMOVED AND INSPECTED AND NOTED TO NO LONGER HAVE THE STENT ON THE BALLOON. PICTURES WERE TAKEN AND THE STENT WAS VISUALLY SEEN IN THE PATIENT. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THE STENT WAS MOVED INTO THE BEST POSITION POSSIBLE FO

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7661914 ↗
• DeathJun 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED BY ANGINA AND NON-ST ELEVATION MI ACUTE. DURING THE PROCEDURE, TWO RESOLUTE ONYX DRUG ELUTING STENT WERE SUCCESSFULLY IMPLANTED BETWEEN THE MID AND PROXIMAL LAD TO TREAT LESIONS EXHIBITING 80% STENOSIS. THE LESIONS WERE ECCENTRIC, DIFFUSE, AND HEAVILY CALCIFIED. ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE DISTAL RCA TO TREAT AN IRREGULARLY CONTOURED LESION EXHIBITING 80% STENOSIS. ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID RCA TO TREAT A LIGHTLY CALCIFIED LESION, EXHIBITING 70% STENOSIS. ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST RPL TO TREAT A LESION EXHIBITING 70% STENOSIS, WITH A DIFFUSE AND ECCENTRIC LESION. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMIES. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESIONS WERE PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. APPROXIMATELY 3 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENT ED WITH STEMI

  Patient problems: Death; Stenosis; Thrombus

  MAUDE report 7572679 ↗
• MalfunctionMay 10, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) EXHIBITING 99% STENOSIS. THERE WAS NO DAMAGE NOTED TO PRODUCT PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING EITHER DEVICE FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS NOTED THAT THE VESSEL WAS TORTUOUS AND CALCIFIED. THE DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502174 ↗
• MalfunctionApr 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS LESION IN THE PROXIMAL LEFT MAIN. NO DAMAGE NOTED TO PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. 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 IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT THROUGH A NON-MDT CATHETER. INTERVENTION WAS NOT REQUIRED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7435475 ↗