Resolute Onyx™ RONYX25038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00643169556867), received between Aug 22, 2017 and Jun 14, 2023 — classified as 4 deaths, 34 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (22 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 62 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD FOUR RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED ON (B)(6) 2022. THIS PROCEDURE WAS PERFORMED FOR CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA). THE VESSEL HAD BEEN STENTED FROM THE OSTIUM TO THE DISTAL SEGMENT AT THE BIFURCATION OF THE RIGHT POSTERIOR DESCENDING ARTERY (RPDA) AND POSTEROLATERAL ARTERY (PLA). THE 2.5 X 38MM RESOLUTE ONYX STENT WAS INFLATED TO 14 ATM, THE 3.0 X 38MM RESOLUTE ONYX STENT WAS INFLATED TO 12 ATM, THE 3.0 X 30MM RESOLUTE ONYX STENT WAS INFLATED TO 15 ATM, AND THE 2.25 X 26MM RESOLUTE ONYX STENT WAS INFLATED TO 10 ATM FOLLOWED BY THE BALLOON AT 24 ATM. A 3.0 X 30MM NON-MEDTRONIC (MDT) BALLOON WAS USED FOR POST-DILATION UP TO 22 ATM AS WELL AS A 2 X 15MM BALLOON UP TO 10 ATM. ALL STENT BALLOONS SUCCESSFULLY DEFLATED POST STENT DILATION. THERE WERE NO DIFFICULTIES NOTED DURING THE REMOVAL OF THE GUIDEWIRE. THE BALLOON OR THE DELIVERY SYSTEM DID NOT SNAG ON THE DEPLOYED STENTS. THERE WERE NO DIFFICULTIES DURING STENT DEPLOYMENT AND THERE WERE NO COMPLICATIONS. APPROXIMATELY 11 MONTHS LATER IT WAS REPORTED THAT THE PATIENT EXPERIENCED, AND SHOWED SIGNS OF WHAT WAS THOUGHT TO BE ANOTHER HEART ATTACK AND ATTENDED THE ED

  Patient problems: Angina; Anxiety; Chest Pain; Dizziness; Dyspnea; Myocardial Infarction; Nausea

  MAUDE report 17123407 ↗
• MalfunctionMay 17, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS ALSO STATED THAT THE STENT COULD NOT CROSS THE LESION AFTER MULTIPLE ATTEMPTS. WHEN THE STENT WAS WITHDRAWN AND REMOVED IT WAS NOTED THAT THE STENT STRUTS WERE DEFORMED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946007 ↗
• InjuryFeb 21, 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 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE RESOLUTE ONYX STENT DISLODGED AFTER IT GOT CAUGHT ON AN OLD NON-MEDTRONIC STENT THAT HAD BEEN PREVIOUSLY IMPLANTED. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16407261 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION WITH HIGH AMOUNTS OF CALCIUM IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE LESION WAS PRE-DILATED AND ATHERECTOMY WAS PERFORMED. IT WAS REPORTED THAT THE STENT APPEARED TO ¿ACCORDION¿ DURING ATTEMPTED DELIVERY. A DECISION WAS MADE TO WITHDRAW THE STENT. IT IS BELIEVED THAT THE STENT GOT CAUGHT ON THE EDGE OF THE GUIDE CATHETER AND WAS FURTHER DAMAGED. THE STENT WOULD NOT ENTER THE GUIDE CATHETER. THE GUIDE CATHETER WAS WITHDRAWN AND WHEN THIS WAS DONE THE STENT WAS STRIPPED OFF OF THE DELIVERY SYSTEM DURING WITHDRAWING. ACCESS WAS GAINED IN THE OPPOSITE FEMORAL ARTERY TO SNARE THE STENT. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13951021 ↗
• InjuryNov 16, 2021Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED 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 NOT USED DURING DELIVERY. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS ALSO REPORTED THAT A SNARE WAS UNSUCCESSFULLY ATTEMPTED TO REMOVE THE DEVICE THAT WAS THEN CRUSHED TO THE WALL OF THE VESSEL USING A NON MEDTRONIC STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12820377 ↗
• MalfunctionAug 31, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT IN THE CX. IT WAS REPORTED THAT IT WAS ATTEMPTED TO CROSS THE LESION AND THERE WAS A KINK IN THE STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391788 ↗
• MalfunctionAug 16, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, MODERATELY TORTUOUS WITH 99% 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 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 A STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX DRUG ELUTING STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12324685 ↗
• MalfunctionJul 21, 2021Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID RCA/ LAD WITH 70% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT WAS IMPLANTED NINE DAYS PAST THE EXPIRATION DATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202939 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX AND LAD. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12056196 ↗
• MalfunctionApr 7, 2021Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID LAD. THE DEVICE WAS INSPECTED PRIOR TO USE 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 DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625981 ↗
• InjuryJan 14, 2021Adverse 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 RCA. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ACUTE RIGHT OCCIPITAL INTRACRANIAL HEMORRHAGE (ACUTE ISCHEMIC STROKE). PATIENT'S MEDICATION WERE ADJUSTED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE AND UNLIKELY RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT IS RECOVERING.

  Patient problems: Stroke/CVA

  MAUDE report 11169255 ↗
• 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 10990323 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, FOUR RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX. TWO EUPHORA PTCA BALLOON WERE ALSO USED. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM ELEVATED CARDIAC ENZYMES. INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED. THE CEC ADJUDICATED THAT A MI OCCURRED IN THE TARGET VESSEL, THE CX.

  Patient problems: Myocardial Infarction

  MAUDE report 10894218 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD .IT WAS REPORTED THAT PATIENT'S CARDIAC ENZYMES WERE ELEVATED POST INDEX PROCEDURE. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI (LAD).

  Patient problems: Myocardial Infarction

  MAUDE report 10866555 ↗
• InjuryNov 11, 2020Material Deformation; 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 10821966 ↗
• MalfunctionOct 29, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON EITHER 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 EITHER DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT ONE OF THE STRUTS ON THE STENT LIFTED DURING THE ADVANCEMENT TO THE LAD. IT WAS FURTHER STATED THAT BOTH DEVICES DID NOT CROSS. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

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

  MAUDE report 10754387 ↗
• MalfunctionOct 16, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED ON EITHER 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 EITHER DEVICE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT ONE OF THE STRUTS ON THE STENT LIFTED DURING THE ADVANCEMENT TO THE LAD. IT WAS FURTHER STATED THAT BOTH DEVICES DID NOT CROSS. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

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

  MAUDE report 10688657 ↗
• MalfunctionSep 2, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  ONE RESOLUTE ONYX DES WAS ATTEMPTED TO BE USED TO TREAT THE MID CX. IT WAS REPORTED THAT THE STENT WAS DEFECTIVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482611 ↗
• DeathSep 2, 2020Adverse 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. APPROXIMATELY 34 MONTHS POST PROCEDURE, PATIENT DEATH OCCURRED. THE DEATH CLASSIFICATION IS UNKNOWN, PATIENT DIED IN SLEEP. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death; Insufficient Information

  MAUDE report 10481287 ↗
• DeathSep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX DES STENTS WERE IMPLANTED IN THE RCA TO TREAT A CHRONIC TOTAL OCCLUSION. ONE NC EUPHORA BALLOON AND TWO OTHER MEDTRONIC BALLOONS WERE USED DURING THE INDEX PROCEDURE. APPROXIMATELY 28 MONTHS POST INDEX PROCEDURE THE PATIENT DIED. THE DEATH WAS CLASSED AS NON SUDDEN CARDIAC DEATH. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND UNLIKELY RELATED TO THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE.

  Patient problems: Death

  MAUDE report 10475821 ↗
• MalfunctionAug 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A LESION. THERE WAS NO ISSUE REMOVING THE STENT 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. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY. THE BALLOON WAS PLACED INSIDE THE STENT AND THE STENT WAS DEPLOYED. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 10471205 ↗
• MalfunctionJun 22, 2020Fracture; 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 SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID 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 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 DEFORMATION OCCURRED IN VIVO DURING ADVANCEMENT / POSITIONING. IT WAS STATED THAT THE TWO RESOLUTE ONYX STENTS FAILED TO CROSS THE LESION. THE STENTS WERE REMOVED FROM THE PATIENT AND INSPECTED. UPON INSPECTION THE STENT STRUTS IN THE MID PORTION WERE NOTED TO BE RAISED AND FRACTURED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10177887 ↗
• MalfunctionApr 30, 2020Material Deformation; Material Deformation

  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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012998 ↗
• InjuryMar 18, 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 1 MONTH POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (VESSEL UNKNOWN). ANGIOGRAM WAS PERFORMED. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9847326 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, 5 RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; THREE IN THE RCA AND TWO IN THE LAD. THE FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES WITH NO TREATMENT CARRIED OUT. PATIENT RECOVERED. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI PCI. CEC ASSESSMENT COMMENTED THAT THERE WAS A LARGE SIDE BRANCH OCCLUSION. INVESTIGATOR ASSESSED THE EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9552187 ↗