Resolute Onyx™ RONYX30038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169557048), received between Jul 26, 2017 and Nov 25, 2024 — classified as 5 deaths, 14 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2024Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A RESOLUTE ONYX CORONARY DRUG ELUTING STENT, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DISTAL BALLOON DID NOT INFLATE AND THE STENT REMAINED CRIMPED, BUT THE PROXIMAL BALLOON INFLATED AND THE STENT IN THAT AREA EXPANDED. HOWEVER, THE FULLY UNINFLATED BALLOON WOULD NOT FULLY EXPAND THE STENT. THE STENT WAS IMPLANTED IN THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20771942 ↗
• MalfunctionDec 19, 2023Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS RETURNED. IT WAS INDICATED THAT THE STENT DISLODGED IN THE DELIVERY CATHETER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18353453 ↗
• 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 17123418 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED INSIDE THE NON-MEDTRONIC GUIDE EXTENSION CATHETER DURING DELIVERY OF THE DEVICE TO THE LESION. IT WAS INDICATED THAT THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280430 ↗
• MalfunctionJun 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  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 WHILE DELIVERING THE STENT ON THE DELIVERY SYSTEM, THE DELIVERY SYSTEM BROKE IN HALF. THE UNDEPLOYED STENT WAS RETRIEVED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073777 ↗
• MalfunctionMay 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A NONE CALCIFIED LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THE DEVICE WAS REMOVED FROM THE HOOP WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE CATHETER OF THE STENT DELIVERY SYSTEM DETACHED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE DETACHED PORTION OF THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819075 ↗
• DeathApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED OF CONGESTIVE SYSTOLIC AND DIASTOLIC HEART AND DIED. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. NOTE ON DEATH CERTIFICATE STATED THAT THE CAUSE OF DEATH COULD ALSO BE ATRIAL FIBRILLATION, CAD AND HYPERTENSION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11640048 ↗
• MalfunctionMar 24, 2021Material 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 LOCATED IN THE PROXIMAL 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 THE STENT FAILED TO CROSS THE TIGHT AND CALCIFIED LESION AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / ADVANCEMENT. PRE-DILATION WAS PREFORMED USING MORE NC BALLOONS AND 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

  MAUDE report 11559649 ↗
• InjuryFeb 26, 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 RCA. DURING A STAGED PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. APPROXIMATELY 16 MONTHS POST INDEX AND STAGED PROCEDURES THE PATIENT SUFFERED FROM CHEST DISCOMFORT. IT WAS REPORTED THAT A SCAR WAS OBSERVED IN THE AREA OF THE STENT, LIKELY A JAILED SEPTAL IN THE MID ANTERIOR LATERAL WALL. PATIENT WAS TREATED WITH MEDICATION. THE PATIENT IS NOT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11385096 ↗
• MalfunctionJan 22, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, NON-CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID 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. IT WAS STATED THAT DUE TO PATIENT ANATOMY, THE GUIDE CATHETER DIDN'T PROVIDE A GOOD BACKUP SUPPORT AND IT IS BELIEVED THAT THE STENT GOT DISRUPTED BY THE TIP OF THE GUIDE CATHETER. 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

  MAUDE report 11213650 ↗
• DeathJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE CIRCUMFLEX. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. [UPDATES UP TO 14 JAN 2021 REVIEWED].

  Patient problems: Insufficient Information

  MAUDE report 11185261 ↗
• InjuryDec 8, 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 DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION AND THE STENT ENDED UP IN THE RIGHT UPPER EXTREMITY. IT WAS STATED THAT THE DISLODGED STENT WAS REMOVED FROM THE PATIENT SUCCESSFULLY USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10966375 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED. CEC ADJUDICATED THAT ON THE NEXT DAY, PATIENT SUFFERED A TARGET VESSEL MYOCARDIAL INFARCTION INVOLVING THE CX AND THE LAD POST INDEX PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 10905296 ↗
• MalfunctionSep 25, 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 IN VIVO OCCURRED DURING POSITIONING / ADVANCEMENT. IT WAS STATED THAT THE STENT WAS DEFECTIVE, AND COULD NOT GO THROUGH, AS IT WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 10585491 ↗
• 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 10475805 ↗
• 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 10475803 ↗
• InjuryAug 20, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX DES WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. 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 BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED WHEN ATTEMPTING TO REMOVE THE STENT FROM THE ARTERY. THE STENT DEFORMATION OCCURRED AT THE TIP OF THE GUIDE CATHETER. IT WAS STATED THAT THE STENT WOULD NOT GO INTO THE TIP OF THE GUIDE CATHETER, SO THE PHYSICIAN ATTEMPTED TO PULL THE GUIDE ALL THE WAY BACK TO THE SHEATH IN THE RIGHT WRIST. THE DEFORMED STENT WOULD NOT GO IN THE SHEATH SO THE PHYSICIAN HAD TO DO A CUT DOWN ON THE RADIAL ARTERY TO GET THE STENT OUT. IT WAS STATED THAT AT THIS POINT THE STENT WAS OFF THE BALLOON AND A HEMOSTAT WAS USED TO REMOVE THE STENT, CAUSING IT TO ELONGATE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10431047 ↗
• InjuryMar 25, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 100% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE 3.00 X 38MM STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE 3.00 X 30MM STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THE 3.00 X 38MM STENT WAS DEPLOYED. AN ATTEMPT TO CROSS THE DEPLOYED 3.00 X 38MM STENT WITH THE 3.00 X 30MM STENT FAILED AND STENT DISLODGEMENT OCCURRED WHEN ATTEMPTING TO REMOVE THE CATHETER. IT WAS REPORTED THAT A SNARE WAS USED TO GRAB THE 3.00 X 30MM STENT WHICH THEN ENTANGLED WITH THE 3.00 X 38MM STENT AND BOTH STENTS WERE REMOVED USING THE SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9876763 ↗
• DeathFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CANCER AND DIED 10 MONTHS POST INDEX PROCEDURE. DEATH CLASSIFICATION IS UNKNOWN. DEATH TOOK PLACE AFTER PATIENT'S STUDY EXIT. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9675955 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM, PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). 100% STENOSIS WAS PRESENT. ALL DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL FOUR DEVICES WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL FOUR DEVICES BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ANY OF THE DEVICES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION AND AN MI OCCURRED IN RELATION TO THE TARGET VESSEL 7 HOURS POST STENT IMPLANTATION. THE CLOT WAS REMOVED BY ASPIRATION WITH A NON MEDTRONIC DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9590959 ↗
• MalfunctionNov 14, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOUS LESION EXHIBITING 95% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT MET RESISTANCE WHEN ATTEMPTING TO CROSS THE LESION. THE STENT WAS REMOVED TO PRE-DILATE THE LESION ONCE AGAIN. IT WAS REPORTED THAT UPON INSPECTION OF THE STENT AFTER REMOVAL THE STENT WAS NOTED TO BE DEFORMED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321169 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD, R-PDA AND RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE BLOOD LOSS ANEMIA SECONDARY TO PREPYLORIC ULCER. EVENT WAS TREATED WITH BLOOD TRANSFUSION AND ME DICATION. PATIENT WAS ON DAPT WITHIN 24 HOURS PRIOR TO EVENT. SPONSOR ASSESSED EVENT AS NOT RELATED TO DEVICE BUT POSSIBLY RELATED ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9144298 ↗
• InjurySep 23, 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 NON TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE OSTIUM RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED BY INFLATING A BALLOON INSIDE IT AND TRAPPING IT IN THE GUIDE, THE ENTIRE SYSTEM WAS REMOVED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9102596 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED THE RCA. IT WAS REPORTED THAT ON THE SAME DAY, THE PATIENT HAD ELEVATED CARDIAC ENZYMES. CEC ADJUDICATED THE EVENT AS A MYOCARDIAL INFARCTION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Myocardial Infarction

  MAUDE report 8849540 ↗
• MalfunctionMay 24, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODE RATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 S TENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE POSITIONED AND UPON REMOVING FROM THE PATIENT STENT DEFORMATION WAS NOTED. A BURR WAS OBSERVED ON THE DISTAL EDGE OF THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER 3.00 X 38 MM RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639546 ↗